FDA · food & medication · last 6 months

The recall log.

Every food and medication enforcement action the FDA has published in the last six months. No account needed — this is public record, made readable.

914 ENFORCEMENT ACTIONS · CLASS I MEANS A REASONABLE PROBABILITY OF SERIOUS HARM

Class IIFoodMar 12, 2026

Western Mixers Produce & Nuts, Inc.: Chilli Spanish Peanuts, First Street brand, 11oz clear plastic container. UPC: None Item Code: 2608-T20

Foreign object (glass) found inside sealed container of finished product.

Product, lots & distribution

Chilli Spanish Peanuts, First Street brand, 11oz clear plastic container. UPC: None Item Code: 2608-T20 — Distribution: Distribution was to two consignees who have a total of 53 retail locations nationwide. — Lots/codes: Lot#: 260422, 260442, 260543, Expiration date: 2/11/2027, 2/13/2027, 2/23/2027 — Status: Ongoing (voluntary: firm initiated)

H-0589-2026 · 384 cases (6 bags/11ounce each per case)

Class IIFoodMar 12, 2026

Western Mixers Produce & Nuts, Inc.: Chilli Spanish Peanuts, Treasured Harvest brand, 25lb clear plastic bag container. UPC:none Item code: 2608-25

Foreign object (glass) found inside sealed container of finished product.

Product, lots & distribution

Chilli Spanish Peanuts, Treasured Harvest brand, 25lb clear plastic bag container. UPC:none Item code: 2608-25 — Distribution: Distribution was to two consignees who have a total of 53 retail locations nationwide. — Lots/codes: Lot#: 260230 Expiration date: 1/23/2027 — Status: Ongoing (voluntary: firm initiated)

H-0590-2026 · 1 case

Class IIFoodMar 12, 2026

Lidl US TRADING: Favorina Chocolate Ladybugs German-Style Nougat, Net Wt 3.52 oz (100g). UPC 2030 4492. Distributed By Lidl US, LLC, 3500 S. Clark St, Arlington, VA 22202. Product of Germany.

Label does not specify type of tree nut contained in the product.

Product, lots & distribution

Favorina Chocolate Ladybugs German-Style Nougat, Net Wt 3.52 oz (100g). UPC 2030 4492. Distributed By Lidl US, LLC, 3500 S. Clark St, Arlington, VA 22202. Product of Germany. — Distribution: DC, DE, GA, MD, NC, NJ, NY, PA, SC, VA — Lots/codes: Best If Used By: Jun 30 2026 — Status: Ongoing (voluntary: firm initiated)

H-0631-2026 · 17,056 units

Class IIIFoodMar 12, 2026

Sato Pharmaceutical Inc.: Yunker(branded) Energy & Health Herbal Supplement with Vitamins; Manufactured by Sato Pharmaceuticals Co. Ltd.; 30ml container. Packed in single serving, 3 units/pack, and 1…

Product does not meet label claim for Vitamin E.

Product, lots & distribution

Yunker(branded) Energy & Health Herbal Supplement with Vitamins; Manufactured by Sato Pharmaceuticals Co. Ltd.; 30ml container. Packed in single serving, 3 units/pack, and 10 units per pack. Single UPC: 49873-916-11 3pack UPC: 49873-916-15 10pack UPC: 49873-916-07 — Distribution: Product was distributed to two domestic consignees who further distribute nationwide. — Lots/codes: Lot: Expiration date: single CXW T Jan-27 3pack CXW T Jan-27 10pack PXW Z Mar-26 10pack XXW W Dec-27 — Status: Ongoing (voluntary: firm initiated)

H-0892-2026 · 25,130 units across all package sizes

Class IIMedicationMar 11, 2026

Fresenius Kabi USA, LLC: 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zuric…

Lack of Assurance of Sterility

Product, lots & distribution

0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case). — Distribution: US Nationwide , Alaska, and Puerto Rico. — Lots/codes: Batch # 6402413, Exp Date: 02/29/2028 — Status: Ongoing (voluntary: firm initiated)

D-0424-2026

Class IIMedicationMar 11, 2026

Fresenius Kabi USA, LLC: 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC:…

Lack of Assurance of Sterility

Product, lots & distribution

0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale NDC Number: 65219-466-60. — Distribution: US Nationwide , Alaska, and Puerto Rico. — Lots/codes: Batch# 6402372, 6402374, Exp Date: 08/31/2026; Batch# 6402437, Exp Date: 10/31/2026. — Status: Ongoing (voluntary: firm initiated)

D-0425-2026

Class IIMedicationMar 11, 2026

Fresenius Kabi USA, LLC: 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich,…

Lack of Assurance of Sterility

Product, lots & distribution

0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 600047, Unit of Use NDC: 65219-468-05, Unit of Sale NDC Number: 65219-468-50. — Distribution: US Nationwide , Alaska, and Puerto Rico. — Lots/codes: Batch# 6402299, 6402300, 6402301, 6402302, 6402303, Exp Date: 01/31/2027; Batch# 6402305, 6402398, Exp Date: 02/28/2027; Batch# 6402467, Exp Date: 04/30/2027; Batch# 6402577, 6402578, Exp Date: 06/30/2027. — Status: Ongoing (voluntary: firm initiated)

D-0426-2026

Class IIMedicationMar 11, 2026

Fresenius Kabi USA, LLC: 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL…

Lack of Assurance of Sterility

Product, lots & distribution

0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-470-05, Unit of Sale NDC Number: 65219-470-30. — Distribution: US Nationwide , Alaska, and Puerto Rico. — Lots/codes: Batch# 23SU10008, Exp Date: 12/31/2026; Batch# 24JU10003, Exp Date: 07/31/2027; Batch# 24LU10011, 24LU10012, Exp Date: 9/30/2027; Batch# 6402273, 6402275, Exp Date: 01/31/2028; Batch# 6402420, 6402421, 6402422, 6402423, Exp Date: 03/31/2028; Batch# 6402473, 6402474, 6402475, 6402476, 6402485, Exp Date: 04/30/2028; Batch# 6402516, Exp Date: 05/31/2028. — Status: Ongoing (voluntary: firm initiated)

D-0427-2026

Class IIMedicationMar 11, 2026

Fresenius Kabi USA, LLC: 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL…

Lack of Assurance of Sterility

Product, lots & distribution

0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20. — Distribution: US Nationwide , Alaska, and Puerto Rico. — Lots/codes: Batch# 24LU10013, 24LU10014, Exp Date: 09/30/2027; Batch# 24NU10001, 24NU10002, Exp Date: 10/31/2027. — Status: Ongoing (voluntary: firm initiated)

D-0428-2026

Class IIMedicationMar 11, 2026

Fresenius Kabi USA, LLC: 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi…

Lack of Assurance of Sterility

Product, lots & distribution

0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-02. — Distribution: US Nationwide , Alaska, and Puerto Rico. — Lots/codes: Batch# 6402428, Exp Date: 10/31/2026; Batch# 6402481, 6402482, Exp Date: 11/30/2026. — Status: Ongoing (voluntary: firm initiated)

D-0429-2026

Class IIMedicationMar 11, 2026

Fresenius Kabi USA, LLC: 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin…

Lack of Assurance of Sterility

Product, lots & distribution

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-03. — Distribution: US Nationwide , Alaska, and Puerto Rico. — Lots/codes: Batch# 6402153, Exp Date: 11/30/2026; Batch# 6402297, 6402298, Exp Date: 01/31/2027; Batch# 6402377, 6402378, 6402379, Exp Date: 02/28/2027; Batch # 6402429, 6402430, 6402431, 6402432, 6402433, Exp Date: 03/31/2027; Batch# 6402434, Exp Date: 04/30/2027; Batch# 6402512, Exp Date: 05/2027; Batch# 6402574, 6402576, Exp Date: 06/30/2027. — Status: Ongoing (voluntary: firm initiated)

D-0430-2026

Class IIMedicationMar 11, 2026

Fresenius Kabi USA, LLC: 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton Drive, Franklin…

Lack of Assurance of Sterility

Product, lots & distribution

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-05. — Distribution: US Nationwide , Alaska, and Puerto Rico. — Lots/codes: Batch# 6402290, 6402291, Exp Date: 01/31/2028; Batch# 6402411, Exp Date: 02/29/2028; Batch# 6402412, 6402419, 6402424, 6402425, 6402426, 6402427, Exp Date: 03/31/2028; Batch# 6402479, 6402480, 6402517, 6402571, Exp Date: 05/31/2028; Batch# 6402518, Exp Date: 06/30/2028. — Status: Ongoing (voluntary: firm initiated)

D-0431-2026

Class IIMedicationMar 11, 2026

Fresenius Kabi USA, LLC: 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius K…

Lack of Assurance of Sterility

Product, lots & distribution

0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20, Unit of Sale NDC Number: 65219-432-85. — Distribution: US Nationwide , Alaska, and Puerto Rico. — Lots/codes: Batch# 23DU10004, Exp Date: 04/30/2026; Batch# 23HU10006, Exp Date: 06/30/2026. — Status: Ongoing (voluntary: firm initiated)

D-0432-2026

Class IIMedicationMar 11, 2026

Fresenius Kabi USA, LLC: 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distribut…

Lack of Assurance of Sterility

Product, lots & distribution

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical Care RTG, LLC, Manufactured by: Fresenius Kabi, Unit of Use NDC: 65219-282-01, Unit of Sale NDC Number: 65219-282-10. — Distribution: US Nationwide , Alaska, and Puerto Rico. — Lots/codes: Batch# 23SU10001, Exp Date: 12/31/2026; Batch# 24AU10003, 24AU10004, 24AU10005, 24AU10008, Exp Date: 01/31/2027; Batch # 24EU10001, 24EU10002, Exp Date: 05/31/2027; Batch# 24PU10002, Exp Date: 11/30/2027; Batch# 25BU10003, Exp Date: 02/29/2028; Batch# 25EU10005, Exp Date: 05/31/2028. — Status: Ongoing (voluntary: firm initiated)

D-0433-2026

Class IIMedicationMar 11, 2026

Fresenius Kabi USA, LLC: 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin…

Lack of Assurance of Sterility

Product, lots & distribution

0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by Fresenius Kabi, Unit of Sale NDC Number: 17271-701-07. — Distribution: US Nationwide , Alaska, and Puerto Rico. — Lots/codes: Batch# 24EU10010, Exp Date: 05/31/2027. — Status: Ongoing (voluntary: firm initiated)

D-0434-2026

Class IIMedicationMar 11, 2026

Fresenius Kabi USA, LLC: 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-456-05, Unit of S…

Lack of Assurance of Sterility

Product, lots & distribution

5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-456-05, Unit of Sale NDC Number: 65219-456-60. — Distribution: US Nationwide , Alaska, and Puerto Rico. — Lots/codes: Batch# 6402296, Exp Date: 07/31/2026. — Status: Ongoing (voluntary: firm initiated)

D-0435-2026

Class IIMedicationMar 11, 2026

Fresenius Kabi USA, LLC: 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-464-05, Unit of S…

Lack of Assurance of Sterility

Product, lots & distribution

5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-464-05, Unit of Sale NDC Number: 65219-464-50. — Distribution: US Nationwide , Alaska, and Puerto Rico. — Lots/codes: Batch# 6402399, 6402400, 6402401, Exp Date: 02/28/2027. — Status: Ongoing (voluntary: firm initiated)

D-0436-2026

Class IIMedicationMar 11, 2026

Fresenius Kabi USA, LLC: 5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit o…

Lack of Assurance of Sterility

Product, lots & distribution

5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 65219-458-30. — Distribution: US Nationwide , Alaska, and Puerto Rico. — Lots/codes: Batch# 6402165, Exp Date: 05/30/2028. — Status: Ongoing (voluntary: firm initiated)

D-0437-2026

Class IIFoodMar 11, 2026

ASUKAR FOODS CORP: TETAS Mireya, Cherry Milkshake (Colita con Leche), i unit Popsicle, Net wt 6OZ. 170GRS. KEEP FROZEN. UPC Code 83822654822

Undeclared allergen: Soy Lecithin

Product, lots & distribution

TETAS Mireya, Cherry Milkshake (Colita con Leche), i unit Popsicle, Net wt 6OZ. 170GRS. KEEP FROZEN. UPC Code 83822654822 — Distribution: FL — Lots/codes: Expiration Date (s): 03/30/2027 — Status: Ongoing (voluntary: firm initiated)

H-0584-2026 · 259 units

Class IFoodMar 11, 2026

Lone Star Dairy Products LLC: Spray Dried Dairy Powder 25 kg bags or 1 metric ton totes

Salmonella spp. identified in finished product testing

Product, lots & distribution

Spray Dried Dairy Powder 25 kg bags or 1 metric ton totes — Distribution: USA — Lots/codes: NFDM Low Heat, NFDM High Heat, and SMP Medium Heat Lot Codes : 26015B; 26016B; 26017B; 26018B; 26019B; 26022B; 26023B; 26024B; 26024BT; 26025B; 26025BT; 26026B; 26027B; 26028B; 26029B; 26030B; 26034B; 26035B; 26040B; 26041B; 26041BT; 26042B; 26042BT; 26043B; 26044B; 26046BT; 26047BT; 26048BT. The products were packaged in 25 kg bags or 1 metric ton totes. — Status: Ongoing (voluntary: firm initiated)

H-0640-2026 · 1,791,543.94 lbs

Class IFoodMar 11, 2026

Griffith Foods Inc.: Costco Service Deli Department 63 MEATLOAF SEASONING MORE FLV Pack Size: 4-5lb. Bags Net Weight: 20lbs Allergy Information: CONTAINS: MILK, WHEAT Packed BY: Griffith Foods STONEC…

Potential Salmonella contamination. The firm was notified from their supplier that the nonfat dry milk may be contaminated with Salmonella.

Product, lots & distribution

Costco Service Deli Department 63 MEATLOAF SEASONING MORE FLV Pack Size: 4-5lb. Bags Net Weight: 20lbs Allergy Information: CONTAINS: MILK, WHEAT Packed BY: Griffith Foods STONECREST, GA 30058 — Distribution: Product was shipped to the following states: AZ, CA, CO, FL, GA, IL, LA, MD, MI, NC, PA, SC, TN, TX & WA. — Lots/codes: Lot 669648 Use By: 2-18-2027, Lot 669649 Use By: 2-18-2027, Lot 669650 Use By: 2-18-2027, Lot 669651 Use By: 2-19-2027, Lot 669652 Use By: 2-19-2027, Lot 669653 Use By: 2-19-2027, Lot 669654 Use By: 2-19-2027 & Lot 669655 Use By: 2-19-2027. — Status: Ongoing (voluntary: firm initiated)

H-0691-2026 · 2,374/4/5lb bags

Class IFoodMar 11, 2026

Griffith Foods Inc.: MILK WASH NET WEIGHT: 50OZ (1417g) Packed Exclusively For: Chick-fil-A, Inc. 5200 Buffington Road Atlanta, GA 30349

Potential Salmonella contamination. The firm was notified from their supplier that the nonfat dry milk may be contaminated with Salmonella.

Product, lots & distribution

MILK WASH NET WEIGHT: 50OZ (1417g) Packed Exclusively For: Chick-fil-A, Inc. 5200 Buffington Road Atlanta, GA 30349 — Distribution: Product was shipped to the following states: AZ, CA, CO, FL, GA, IL, LA, MD, MI, NC, PA, SC, TN, TX & WA. — Lots/codes: L 671742 Best By AUG 30 2026, L 671741 Best By AUG 30 2026, L 670653 Best By AUG 24 2026, L 669617 Best By AUG 17 2026, L 669616 Best By AUG 17 2026, L 669611 Best By AUG 16 2026 & L 669610 Best By AUG 16 2026. — Status: Ongoing (voluntary: firm initiated)

H-0692-2026 · 1,450cs/10/50oz bags

Class IFoodMar 11, 2026

Griffith Foods Inc.: MILK-N-EGG MIX NET WEIGHT: 50 LBS, PROCESSED FROM NONFAT DRIED MILK, DRIED WHEY, DRIED EGG WHITES CONTAINS: EGG, MILK Mfred By: Griffith Goods, One Griffith Way, Stonecrest, GA

Potential Salmonella contamination. The firm was notified from their supplier that the nonfat dry milk may be contaminated with Salmonella.

Product, lots & distribution

MILK-N-EGG MIX NET WEIGHT: 50 LBS, PROCESSED FROM NONFAT DRIED MILK, DRIED WHEY, DRIED EGG WHITES CONTAINS: EGG, MILK Mfred By: Griffith Goods, One Griffith Way, Stonecrest, GA — Distribution: Product was shipped to the following states: AZ, CA, CO, FL, GA, IL, LA, MD, MI, NC, PA, SC, TN, TX & WA. — Lots/codes: L 669896 Use By: 2-17-2027, L 669833 Use By: 2-16-2027, L 668712 Use By: 2-16-2027, L 668711 Use By: 2-16-2027, L 668710 Use By: 2-16-2027, L 668709 Use By: 2-16-2027 & L 668708 Use By: 2-16-2027. — Status: Ongoing (voluntary: firm initiated)

H-0693-2026 · 833/50lb bags

Class IIFoodMar 11, 2026

Horizon Organic Dairy, LLC: Horizon Organic Chocolate Organic Lowfat Milk. Saleable Unit UPC: 742365004322 (6-8 FL OZ Milk Boxes). Case: ORG MILK 1% DHA CHOCOLATE 3/6PK (item 136518). Case UPC: 74236…

Package integrity compromised.

Product, lots & distribution

Horizon Organic Chocolate Organic Lowfat Milk. Saleable Unit UPC: 742365004322 (6-8 FL OZ Milk Boxes). Case: ORG MILK 1% DHA CHOCOLATE 3/6PK (item 136518). Case UPC: 742365004322. Three 6-Packs, 18-8 FL OZ Containers (236 mL)/case. Individual milk boxes are packed in 8-oz Tetra Pak cartons. Distributed by: Horizon Organic Dairy, LLC (Horizon) 12303 Airport Way Suite 200 Broomfield, CO 80021. Shelf Stable, refrigerate after opening. — Distribution: Distributed to the following states: AZ, CA, NV, OR. — Lots/codes: BEST BY 14 AUG 2026 and BEST BY 15 AUG 2026 — Status: Completed (voluntary: firm initiated)

H-0711-2026 · 3,522 cases (18-8oz cartons/case)

Class IFoodMar 10, 2026

Nuts.com Inc.: Nuts.com, Espresso Malted Milk Balls, 1 lb. sealed pouch & 20 lb. clear poly bag in Nuts.com cardboard box . Packages are only sold individually .

Undeclared Allergen - Wheat and Soy (from Soy Lecithin). The ingredient statement and allergen information do not include wheat or soy.

Product, lots & distribution

Nuts.com, Espresso Malted Milk Balls, 1 lb. sealed pouch & 20 lb. clear poly bag in Nuts.com cardboard box . Packages are only sold individually . — Distribution: The recalled product was distributed throughout the US. — Lots/codes: Product SKU Item Name 5106-01 Espresso Malted Milk Balls — Status: Terminated (voluntary: firm initiated)

H-0632-2026 · 10,190 lbs

Class IIMedicationMar 9, 2026

Zydus Pharmaceuticals (USA) Inc: Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA)…

Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.

Product, lots & distribution

Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7 — Distribution: Nationwide in the USA — Lots/codes: Lot #: S2520249, S2520250, S2520267, Exp. Date 2027/Jan; S2520303, S2520305, S2520332, Exp. Date 2027/Feb; S2540208, S2540209, Exp. Date 2027/Apr — Status: Ongoing (voluntary: firm initiated)

D-0400-2026 · 60,541 bottles

Class IIFoodMar 9, 2026

South Florida Food, LLC: Pan de Bono (Cheese Bread), 100 units per Paper Cardboard Box, Net Wt 14.4 lb. KEEP FROZEN

Undeclared Soy.

Product, lots & distribution

Pan de Bono (Cheese Bread), 100 units per Paper Cardboard Box, Net Wt 14.4 lb. KEEP FROZEN — Distribution: Products distribute in FL — Lots/codes: Lot #: 02/26/26 Expiration date:07/26/2026 — Status: Ongoing (voluntary: firm initiated)

H-0623-2026 · 15 master cardboard Box 100 units each, Net Wt 14.4 lb

Class IIMedicationMar 6, 2026

PAYLESS COMPOUNDERS, LLC: Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beaverton, OR

Lack of Assurance of Sterility

Product, lots & distribution

Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beaverton, OR — Distribution: OR — Lots/codes: Lot Number 01-27-2026@14S.5 — Status: Ongoing (voluntary: firm initiated)

D-0471-2026 · 91 vials

Class IFoodMar 6, 2026

Kradjian Importing Company, Inc.: MID EAST Jordanian Zaatar spice mix; NET Wt. 5lb plastic bag; UPC: 094379607038 Packed by: Propack Inc. Sunvalley, CA 91354

Undeclared allergen ingredients (sesame and wheat) in Zaatar Spice mix.

Product, lots & distribution

MID EAST Jordanian Zaatar spice mix; NET Wt. 5lb plastic bag; UPC: 094379607038 Packed by: Propack Inc. Sunvalley, CA 91354 — Distribution: Distribution is to bakeries for further processing into various Zaatar breads and pastries. — Lots/codes: m-dd format of repacking — Status: Terminated (voluntary: firm initiated)

H-0576-2026 · 4,400 pounds

Class IFoodMar 6, 2026

Distribuidora de Alimentos Sendero LLC: Gorditas de Azucar UPC 860010238134

Gorditas and Doraditas are missing the following allergens in product label: Wheat and Soy

Product, lots & distribution

Gorditas de Azucar UPC 860010238134 — Distribution: Texas — Lots/codes: All expiration dates — Status: Completed (voluntary: firm initiated)

H-0648-2026 · 2500 units

Class IFoodMar 6, 2026

Distribuidora de Alimentos Sendero LLC: Doraditas de Azucar UPC 5901234123457

Gorditas and Doraditas are missing the following allergens in product label: Wheat and Soy

Product, lots & distribution

Doraditas de Azucar UPC 5901234123457 — Distribution: Texas — Lots/codes: All expiration dates — Status: Completed (voluntary: firm initiated)

H-0649-2026 · 500 units

Class IIMedicationMar 5, 2026

Apotex Corp.: Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1.

Lack of Assurance of Sterility

Product, lots & distribution

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1. — Distribution: U.S. Nationwide — Lots/codes: Lots VJ8599, Exp Date 09/30/2026 & VL1668, Exp Date 01/31/2027 — Status: Ongoing (voluntary: firm initiated)

D-0407-2026 · 107,136 vials

Class IIFoodMar 5, 2026

JFE FRANCHISING INC: " Dumpling Vegetable 4.5 oz 011110658067 " Loaded Dumpling Vegetable 5.7 oz 011110696953

Foreign Object (Glass)

Product, lots & distribution

" Dumpling Vegetable 4.5 oz 011110658067 " Loaded Dumpling Vegetable 5.7 oz 011110696953 — Distribution: AK, AR, AZ, CA, OR, CO, CT, DC, DE, ID, IN, KY, LA, MA, MD, ME, MI, MN, MS, MT, ND, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WA, WI, WV, WY — Lots/codes: tba — Status: Ongoing (voluntary: firm initiated)

H-0638-2026 · Unknown

Class IIFoodMar 5, 2026

JFE FRANCHISING INC: " Dumpling Party Tray (20pcs) Vegetable 13 oz 011110661173 " Dumpling Party Tray (40pcs) Vegetable 26 oz 011110661180 " Cheetos Flamin Hot Loaded Dumpling Vegetable 6oz 011110663…

Foreign Object (Glass)

Product, lots & distribution

" Dumpling Party Tray (20pcs) Vegetable 13 oz 011110661173 " Dumpling Party Tray (40pcs) Vegetable 26 oz 011110661180 " Cheetos Flamin Hot Loaded Dumpling Vegetable 6oz 011110663474 — Distribution: AK, AR, AZ, CA, OR, CO, CT, DC, DE, ID, IN, KY, LA, MA, MD, ME, MI, MN, MS, MT, ND, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WA, WI, WV, WY — Lots/codes: tba — Status: Ongoing (voluntary: firm initiated)

H-0639-2026 · Unknown

Class IIFoodMar 4, 2026

Disaronno Ingredients S.p.a.: Montebianco, 113542 Base Vegan, 2 Kg (4.41 Lb) Bag, packed 8 bags per master case of 2 Kg (4.41 lb) each total case weight,16 Kg / 35.27 lb

Undeclared allergen Milk. The presence of the milk allergen in the product was found to exceed acceptable levels despite the product being labeled with the statement *May contain milk. *

Product, lots & distribution

Montebianco, 113542 Base Vegan, 2 Kg (4.41 Lb) Bag, packed 8 bags per master case of 2 Kg (4.41 lb) each total case weight,16 Kg / 35.27 lb — Distribution: Product distributed in MD — Lots/codes: Lot#L070725 0727 BBE: 31.07.2027 — Status: Terminated (voluntary: firm initiated)

H-0690-2026 · 15 boxes (8 bags per case of 2Kg 4,41 lb each one) and 6 bags

Class IIMedicationMar 3, 2026

Rising Pharma Holding, Inc.: Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin:…

Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing

Product, lots & distribution

Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51. — Distribution: Nationwide within the U.S — Lots/codes: Lot #: 1TM0524003A, Exp. Date 09/2026. — Status: Ongoing (voluntary: firm initiated)

D-0384-2026 · 1200 bottles

Class IIMedicationMar 3, 2026

K.C. Pharmaceuticals, Inc: Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KA…

Lack of Assurance of Sterility

Product, lots & distribution

Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, UPC 0 70038 47010 6; b) QC-Quality Choice, Sterile Eye drops Irritation Relief, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-190-14; c) Discount drug mart, Eye Drops A.C., Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01158 0; d) Good Sense Sterile Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-160-01; e) Walgreens, Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 17954 4; f) CAREONE, Itchy relief Eye drops, DISTRIBUTED BY: FOODHOLD U.S.A, LLC., LANDOVER, MD 20785; g) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 25114 4; h) TopCare health TM, DISTRIBUTED BY: TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, UPC 0 36800 03640 6; i) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-598-01; j) H.E.B A.C. Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43746 7 — Distribution: Nationwide in the US — Lots/codes: Lot: a) AC24E01, Exp.: 05/31/26; b) AC24E01, Exp.: 05/31/26; c) AC24E01, Exp.: 05/31/26; d) AC24E01, Exp.: 05/31/26; e) AC24E01, Exp.: 05/31/26; f) AC24E01, Exp.: 05/31/26; g) AC24E01, Exp.: 05/31/26; h)AC24E01, Exp.: 05/31/26; i) AC24E01, Exp.: 05/31/26; j) AC24E01, Exp.: 05/31/26; — Status: Ongoing (voluntary: firm initiated)

D-0409-2026 · 182,424 bottles

Class IIMedicationMar 3, 2026

K.C. Pharmaceuticals, Inc: EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles, Sterile; a) Walgreens, DISTRIBUTED BY: W…

Lack of Assurance of Sterility

Product, lots & distribution

EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles, Sterile; a) Walgreens, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015; UPC 3 11917 20074 3; b) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202; c) CVS Health, Distributed by :CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 43544 1; d) QC-Quality Choice, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-191-14; e) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01155 9; f) Foster & Thrive, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141, NDC 70677-1158-1; g) GoodSense, Distributed By: Perrigo Direct Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-130-01; h) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03641 3; I) DG health Sterile, DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 02556 3; j) Fast Acting, CODE RED Eye Drops, Sterile, Distributed by: 4 Trees, LLC, NDC 83817-963-01. — Distribution: Nationwide in the US — Lots/codes: Lot: a) AR24D01, Exp.: 04/30/26; AR24G01, AR24G02, Exp.: 07/31/26; AR24M01, Exp.: 10/31/26; b) AR24D01, Exp.: 04/30/26; AR24G01, Exp.: 07/31/26; AR24M01, Exp.: 10/31/26; c) AR24D01, Exp.: 04/30/26; AR24G02, Exp.: 07/31/26; AR24M01, Exp.: 10/31/26; d) AR24G02, Exp.: 07/31/26; e) AR24G02, Exp.: 07/31/26; f) AR24G02, Exp.: 07/31/26; g) AR24M01, Exp.: 10/31/26, h) AR24G01, Exp.: 07/31/26; AR24M01, Exp.:10/31/26; I) AR24M01, Exp.:10/31/26; j) AR24D01, Exp.: 04/30/26. — Status: Ongoing (voluntary: firm initiated)

D-0410-2026 · 303,216 bottles

Class IIMedicationMar 3, 2026

K.C. Pharmaceuticals, Inc: Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 FL OZ (15 mL) bottles; a) GERI CARE, Distributed by: Gericare Pharmaceutical…

Lack of Assurance of Sterility

Product, lots & distribution

Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 FL OZ (15 mL) bottles; a) GERI CARE, Distributed by: Gericare Pharmaceuticals Corp., Lakewood, NJ 08701, NDC 57896-181-05; b) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 36100 3; c) Rite Aid, DISTRIBUTEDBY: RITE AID, Camp Hill, PA 17011, NDC 11822-1067-2; d) LEADER DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0502-1; e) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01156 6; f) H-E-B, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43741 2; g) Foster & Thrive, Distributed by: McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1158-1; h) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-718-01; i) DG health Sterile, DISTRIBUTED BY OLD EAST MAIN CO., GOODLETTSVILLE, TN 37072, UPC 0 95072 02656 0; j) Harris Teeter, Eye Drops, Artificial Tears, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 71303 2; k) exchange select, Manufactured for your Military Exchanges by: KC Pharmaceuticals, Inc., Pomona, CA 91768, UPC 6 14299 05620 6; l) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 46122-605-05 — Distribution: Nationwide in the US — Lots/codes: Lot: a) LT24E01, LT24E02, LT24E03, Exp.: 05/31/26; LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; LT24M01, LT24M02, Exp.: 10/31/26; b) LT24E03, Exp.: 05/31/26; LT24F01, Exp.:06/30/26; LT24G01, Exp.:07/31/26; LT24M02, Exp.: 10/31/26; c) LT24F01, Exp.: 06/30/26; d) LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; e) LT24F01, Exp.: 06/30/26; f) LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; g) LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; h) LT24F01, Exp.: 06/30/26; i) LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; j) LT24F01, Exp.: 06/30/26; k) LT24G01, Exp.: 07/31/26; L) LT24F01,… — Status: Ongoing (voluntary: firm initiated)

D-0411-2026 · 1,023,096 bottles

Class IIMedicationMar 3, 2026

K.C. Pharmaceuticals, Inc: Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017…

Lack of Assurance of Sterility

Product, lots & distribution

Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0457-1; b) Harris Teeter, Eye Drops, Ultra Lubricant, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 73588 1; c) Foster & Thrive, Lubricating Eye Drops, Distributed by: McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1160-1; d) Walgreens Lubricant Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20167 2; e) P high performance Eye drops, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 09876 3; f) Kroger high performance lubricant eye drops, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202; g) Good Sense Ultra Lubricant Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-160-01; h) meijer Ultra Lubricant, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-937-01; i) CVS Health, Fast Acting Lubricant Eye Drops, Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 39690 2; j) CVS Health, Fast Acting Lubricant Eye Drops, Twin pack, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 44738 3; k) QC-Quality Choice, Lubricant Eye Drops, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-029-15; l) AVENOVA LUBRICANT EYE DROPS, Twin pack, Distributed by: NovaBay Pharmaceuticals, Inc., CA 94608, UPC 8 57005 00411 9. — Distribution: Nationwide in the US — Lots/codes: Lot: a) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; b) SU24E01, Exp.: 5/31/26; c) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; d) SU24E01, SU24E02, Exp.: 5/31/26; e) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; f) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; g) SU24E01, SU24E02, SU24E03, Exp.: 5/31/26; h) SU24E01, Exp.: 5/31/26; i) SU24E01, SU24E02, SU24E03, Exp.: 5/31/26; j) SU24E03, Exp.: 5/31/26; k) SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; L) SU24K01, Exp.: 9/30/26. — Status: Ongoing (voluntary: firm initiated)

D-0412-2026 · 245,184 bottles

Class IIMedicationMar 3, 2026

K.C. Pharmaceuticals, Inc: Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL) bottles; a) Good Sense Sterile Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree…

Lack of Assurance of Sterility

Product, lots & distribution

Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL) bottles; a) Good Sense Sterile Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-141-01; b) Walgreens, Eye Drops, Original Formula, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20073 6; c) Walgreens, Eye Drops, Original Formula, 2 Bottles, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20076 7; d) Kroger Sterile eye drops, Original, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 1110 38597 0; e) Sterile eye drops, Regular formula, Product manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404, UPC 3 66715 68324 3; f) CVP Sterile EYE DROPS, Distributed by: Salado Sales. Inc., Temple, TX 76503; UPC 7 61606 16500 3; g) Harris Teeter, Eye Drops, Original, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 71302 5; h) H.E.B Original Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43747 4; i) Rugby tetrahydrozoline ophthalmic Solution, Distributed by: RUGBY LABORATORIES, IN 46268, NDC 0536-1217-94, j) Equaline, DISTRIBUTED BY UNFI, PROVIDENCE, RI 02908, UPC 0 41163 25110 6; k) Discount drug mart, EyeDrops ORIGINAL, Discount Drug Mart Food Fair, 211 Commerce Drive, Medina, OH 44256, UPC 0 93351 01156 3; L) LEADER Original Eye Drops, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0454-1; m) CAREone, DISTRIBUTED BY FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 41520-431-05; n) Circle K sterile eye drops, Product manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404, Proudly distributed by Circle K Stores Inc., UPC 1 94283 65185 8; o) DG health Original Formula, DISTRIBUTED BY OLD EAST MAIN CO., GOODLETTSVILLE, TN 37072, UPC 0 95072 00556 5; p) Good Neighbor Pharmacy Eye Drops, Original Formula, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 24385-075-05; q) TopCare health, Original Eye Drops, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03639 0; r) Best Choice, Eye Drops, ORIGINAL, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., KANSAS CITY, KS 66106, UPC 0 70038 47011 3 — Distribution: Nationwide in the US — Lots/codes: Lot: a) RG24E01, Exp.: 05/31/26; RG24G02, Exp.: 07/31/26; b) RG24E01, Exp.: 05/31/26; RG24G02, Exp.: 07/31/26; c) RG24G02, Exp.: 07/31/26; d) RG24E01, Exp.: 05/31/26; RG24G01, RG24G02; Exp.: 07/31/26; e) RG24E01, Exp.: 05/31/26; RG24G01, Exp.: 07/31/26; f) RG24E01, Exp.: 05/31/26; RG24G02; Exp.: 07/31/26; g) RG24E01, Exp.: 05/31/26; h) RG24E01, Exp.: 05/31/26; RG24G02, Exp.: 07/31/26; i) RG24E01, Exp.: 05/31/26; j) RG24E01, Exp.: 05/31/26; k) RG24E01, Exp.: 05/31/26; L) RG24E01, Exp.: 05/31/26; m) RG24E01, Exp.: 05/31/26; n) RG24G01, Exp.: 07/31/26; o) RG24G01, Exp.: 07/31/26; p) RG24G02, Exp… — Status: Ongoing (voluntary: firm initiated)

D-0413-2026 · 378,144 bottles

Class IIMedicationMar 3, 2026

K.C. Pharmaceuticals, Inc: Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bottles; a) Industrial Eye Relief, Distributed by: Cintas Corp., Mason, O…

Lack of Assurance of Sterility

Product, lots & distribution

Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bottles; a) Industrial Eye Relief, Distributed by: Cintas Corp., Mason, OH 45040, UPC 130209; b) Good Neighbor Pharmacy Eye Drops, Redness & Dry Eye Relief, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 46122-606-05; c) Colirio Ojo De Aguila Eye Drops, Distributed by: Grandall Distributing Co., Inc., Glendale, CA 91204-2707, UPC 3 48201 01615 5; d) Colirio OFTAL-MYCIN, Distributed by: Grandall Distributing Co., Inc., Glendale, CA 91204-2707, UPC 3 48201 01613 1; e) LEADER Redness Relief, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0010-1; f) Equaline, sterile redness relief, DISTRIBUTED BY UNFI, PROVIDENCE, RI 02908, UPC 0 41163 46151 2; g) Walgreens, Redness Relief Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 17741 0; h) Foster & Thrive, Redness Relief Eye Drops, Sterile, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1161-1; i) LUBRICANT EYE DROPS, Redness Relief, DISTRIBUTEDBY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011, NDC 11822-6453-4; j) Discount drug mart, Eye Drops Redness Relief, Distributed by: Discount Drug Mart, Medina, OH 44256, UPC 0 93351 03411 4 — Distribution: Nationwide in the US — Lots/codes: Lot: a) RL24D01, Exp.: 04/30/26; RL24F01, RL24F02, Exp.:06/30/26; b) RL24F01, RL24F02, Exp.:06/30/26; c) RL24F01, Exp.:06/30/26; d) RL24F02, Exp.:06/30/26; e) RL24F01, RL24F02, Exp.:06/30/26; f) RL24F01, RL24F02, Exp.:06/30/26; g) RL24F01, RL24F02, Exp.:06/30/26; h) RL24F01, Exp.:06/30/26; i) RL24F01, Exp.:06/30/26; j) RL24F02, Exp.:06/30/26; k) — Status: Ongoing (voluntary: firm initiated)

D-0414-2026 · 315,144 bottles

Class IIMedicationMar 3, 2026

K.C. Pharmaceuticals, Inc: STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles; a) Rugby LUBRICATING EYE DROPS, Distributed by:…

Lack of Assurance of Sterility

Product, lots & distribution

STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles; a) Rugby LUBRICATING EYE DROPS, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1219-94; b) Walgreens, Lubricant Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20300 3 — Distribution: Nationwide in the US — Lots/codes: Lot: a) SY24K01, SY24K02, Exp.: 09/30/26; b) SY24K01, SY24K02, Exp.: 09/30/26. — Status: Ongoing (voluntary: firm initiated)

D-0415-2026 · 74,016 bottles

Class IIMedicationMar 3, 2026

K.C. Pharmaceuticals, Inc: Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 430…

Lack of Assurance of Sterility

Product, lots & distribution

Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0011-1; b) Good Sense, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-110-01; c) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 24385-006-05; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 09331 7; e) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., KANSAS CITY, KS 66106, UPC 0 70038 47008 3; f) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38600 7; g) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 00976 9; h) Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-189-14 — Distribution: Nationwide in the US — Lots/codes: Lot: a) AT24D01, Exp.: 04/30/26; AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; b) AT24D01, Exp.: 04/30/26; AT24E01, AT24E02, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; c) AT24D01, Exp.: 04/30/26; AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; d) AT24D01, Exp.: 04/30/26; AT24E01, AT24E02, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; e) AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; f) AT24E01, AT24E02, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; g) AT24E02, Exp.: 05/31/26. — Status: Ongoing (voluntary: firm initiated)

D-0416-2026 · 589,848 bottles

Class IIMedicationMar 3, 2026

Owen Biosciences Inc.: FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0.5 fl. oz./15ml; and b)1 fl. oz./30ml tubes; Made in the USA for FarmHouse F…

Chemical contamination: Presence of benzene

Product, lots & distribution

FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0.5 fl. oz./15ml; and b)1 fl. oz./30ml tubes; Made in the USA for FarmHouse Fresh, 8797 CR 858 McKinney, Texas — Distribution: U.S. Nationwide — Lots/codes: Lot #2595500, Exp.10/2/2026 Lot #2549700, Exp.6/12/2026 Lot #2638200, Exp.4/30/2027 — Status: Ongoing (voluntary: firm initiated)

D-0452-2026 · 7,975 tubes

Class IIMedicationMar 3, 2026

Owen Biosciences Inc.: HydroPeptide CLEAR ALLIANCE SERUM, 2.5% BENZOYL PEROXIDE, a)1 FL OZ/30ml; b) 2 FL OZ/60ml spray bottle; DIST BY HYDROPEPTIDE LLC, ISSAQUAH, WA 98027

Chemical contamination: Presence of benzene

Product, lots & distribution

HydroPeptide CLEAR ALLIANCE SERUM, 2.5% BENZOYL PEROXIDE, a)1 FL OZ/30ml; b) 2 FL OZ/60ml spray bottle; DIST BY HYDROPEPTIDE LLC, ISSAQUAH, WA 98027 — Distribution: U.S. Nationwide — Lots/codes: Lot# 2518800, Exp.: 4/30/2027 Lot# 2518900, Exp.: 4/1/2027 — Status: Ongoing (voluntary: firm initiated)

D-0453-2026 · 9,850 bottles

Class IIMedicationMar 3, 2026

Owen Biosciences Inc.: SLMD BP Acne Spot Treatment, 10% Benzoyl Peroxide, 0.5 fl. oz - 15 mL bottles, Sandra Lee MD, Distributed by Skin PS Brands, Culver City, CA90232.

Chemical contamination: Presence of benzene

Product, lots & distribution

SLMD BP Acne Spot Treatment, 10% Benzoyl Peroxide, 0.5 fl. oz - 15 mL bottles, Sandra Lee MD, Distributed by Skin PS Brands, Culver City, CA90232. — Distribution: U.S. Nationwide — Lots/codes: Lot# 2567200, Exp.8/1/26 Lot# 2691600, Exp.10/30/2027 — Status: Ongoing (voluntary: firm initiated)

D-0454-2026 · 2269 bottles

Class IIMedicationMar 3, 2026

Owen Biosciences Inc.: SLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%, a) 0.7 fl. oz - 21 mL and b) 1.5 fl. oz. - 44mL bottles, SANDRA LEE MD., Distributed by Skin PS Brands, Culver City, C…

Chemical contamination: Presence of benzene

Product, lots & distribution

SLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%, a) 0.7 fl. oz - 21 mL and b) 1.5 fl. oz. - 44mL bottles, SANDRA LEE MD., Distributed by Skin PS Brands, Culver City, CA 90232. — Distribution: U.S. Nationwide — Lots/codes: Lot# 2691700, Exp.10/31/2027 Lot# 2691800, Exp. 11/4/2027 — Status: Ongoing (voluntary: firm initiated)

D-0455-2026 · 2,500 bottles

Class IFoodMar 3, 2026

FRITO-LAY NORTH AMERICA, INC.: Miss Vickies Spicy Dill Pickle; 8 oz bag

Undeclared Allergen: Milk

Product, lots & distribution

Miss Vickies Spicy Dill Pickle; 8 oz bag — Distribution: Arkansas, Louisiana, Mississippi, New Mexico, Oklahoma, and Texas. — Lots/codes: "Guaranteed Fresh" date of 21 APR 2026 And one of these 9-digit Manufacturing Codes 38U301414 48U101514 — Status: Terminated (voluntary: firm initiated)

H-0571-2026 · 5,292 bags

Class IIFoodMar 3, 2026

Ajinomoto Foods North America Inc.: Item 5650173 Trader Joe's Japanese Style Fried Rice with Edamame, Tofu, and Hijiki Seaweed. SKU #097908. Net wt. 1lb. per bag. Retail bag UPC 00979085. Product pac…

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

Product, lots & distribution

Item 5650173 Trader Joe's Japanese Style Fried Rice with Edamame, Tofu, and Hijiki Seaweed. SKU #097908. Net wt. 1lb. per bag. Retail bag UPC 00979085. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 24/1lb. bags per case. Case UPC 10097908500001. All products are intended to be stored frozen and fully cooked to 165F before eating. — Distribution: Distributed in AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WY. — Lots/codes: Best By Dates Range: 2/28/2026 to 11/14/2026 Best By Dates: 2/28/2026 3/7/2026 3/14/2026 3/21/2026 3/28/2026 4/3/2026 4/4/2026 4/16/2026 4/17/2026 4/25/2026 5/2/2026 5/9/2026 5/23/2026 5/30/2026 6/5/2026 6/6/2026 6/12/2026 6/13/2026 7/8/2026 7/9/2026 7/17/2026 7/18/2026 7/24/2026 7/25/2026 8/1/2026 8/15/2026 8/22/2026 9/12/2026 9/26/2026 10/3/2026 10/10/2026 10/17/2026 10/24/2026 10/30/2026 10/31/2026 11/7/2026 11/14/2026 — Status: Ongoing (voluntary: firm initiated)

H-0591-2026 · 3,059,808 lbs. or 127,492 cases (24 lbs. per case)

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