Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 1000 mg, 72 chewable tablets, Distributed by: Amerisourcebergen, 1 West First Avenue, Conshohocken, PA, 19428,…
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 1000 mg, 72 chewable tablets, Distributed by: Amerisourcebergen, 1 West First Avenue, Conshohocken, PA, 19428, NDC 24385-595-23. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, Exp 1/31/2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: Extra strength Antacid Calcium Carbonate 750 mg, chewable tablets, 96-count bottle, DISTRIBUTED BY CASEY'S MARKETING COMPANY, ANKENY, IA 50521, UPC: 0 98437 24361 9.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
Extra strength Antacid Calcium Carbonate 750 mg, chewable tablets, 96-count bottle, DISTRIBUTED BY CASEY'S MARKETING COMPANY, ANKENY, IA 50521, UPC: 0 98437 24361 9. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276118, Exp 1/31/2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: 24/7 life BY 7-ELEVEN, Extra strength Antacid Tablets, Calcium Carbonate 750 mg, 96 chewable tablets, DISTRIBUTED BY 7-ELEVEN, IRVING, TX 75063, UPC 0 5254863573 2.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
24/7 life BY 7-ELEVEN, Extra strength Antacid Tablets, Calcium Carbonate 750 mg, 96 chewable tablets, DISTRIBUTED BY 7-ELEVEN, IRVING, TX 75063, UPC 0 5254863573 2. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276119, Exp 1/31/2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: MARKET BASKET ANTACID Calcium Carbonate 1000 mg, ULTRA STRENGTH, 72 Tablets, Distributed by: De Moules Supermarkets, Inc.,Tewksbury, Mass 01875, UPC 0 49705 83149 6.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
MARKET BASKET ANTACID Calcium Carbonate 1000 mg, ULTRA STRENGTH, 72 Tablets, Distributed by: De Moules Supermarkets, Inc.,Tewksbury, Mass 01875, UPC 0 49705 83149 6. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, expires: JAN 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-127-80.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-127-80. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276118, 1276119, expires: JAN 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: CAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-178-23.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
CAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-178-23. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716259, Exp 3/31/2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS, Calcium Carbonate 750 mg, 96 Tablets, Distributed by: Drug Mart- Food Fair Medina, OH 44256, UPC: 0 93351 03992 8.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS, Calcium Carbonate 750 mg, 96 Tablets, Distributed by: Drug Mart- Food Fair Medina, OH 44256, UPC: 0 93351 03992 8. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276118, Exp 1/31/2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOOD BRANDS, LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA.…
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOOD BRANDS, LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA., NDC 55319-171-68. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, expires: JAN 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOOD BRANDS, LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA.…
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOOD BRANDS, LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA., UP: 0 32251-92282-4. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716259, expires: MAR 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: Harris Teeter, ULTRA STRENGTH ANTACID, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, Distributed by: Harris Teeter, LLC.,MATTHEWS, NC 28105, UPC: 0 72036-73108-1.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
Harris Teeter, ULTRA STRENGTH ANTACID, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, Distributed by: Harris Teeter, LLC.,MATTHEWS, NC 28105, UPC: 0 72036-73108-1. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, expires: JAN 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82497 1.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82497 1. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276119, expires: Jan 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82514 5.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82514 5. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, expires: JAN 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: H.E.B Extra Strength Calcium Carbonate Antacid Tablets, Calcium Carbonate 750 mg, 96 Chewable Tablets, MADE WITH PRIDE & CARE FOR H.E.B, 646 S. FLORES ST, SAN ANTONIO, TX, NDC…
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
H.E.B Extra Strength Calcium Carbonate Antacid Tablets, Calcium Carbonate 750 mg, 96 Chewable Tablets, MADE WITH PRIDE & CARE FOR H.E.B, 646 S. FLORES ST, SAN ANTONIO, TX, NDC 37808-136-22. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276118, expires: JAN 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: GOODSENSE Extra Strength, Antacid TABLETS, Calcium Carbonate 750 mg, 96 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-129-22.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
GOODSENSE Extra Strength, Antacid TABLETS, Calcium Carbonate 750 mg, 96 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-129-22. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276118, expires: JAN- 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: GOODSENSE Ultra Strength, Antacid TABLETS, Calcium Carbonate 1000 mg, 72 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-171-68.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
GOODSENSE Ultra Strength, Antacid TABLETS, Calcium Carbonate 1000 mg, 72 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-171-68. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, expires: JAN- 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-129-22.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-129-22. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276118, expires: JAN- 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-171-68.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-171-68. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, expires: JAN- 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: TopCare health, EXTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 750mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-128-…
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
TopCare health, EXTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 750mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-128-22. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276119, expires: JAN- 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: TopCare health, ULTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 1000mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-129…
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
TopCare health, ULTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 1000mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-129-68. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, expires: JAN- 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Ajanta Pharma USA Inc: Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807, NDC 27241-120…
CGMP Deviations
Product, lots & distribution
Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807, NDC 27241-120-04. — Distribution: U.S. Nationwide — Lots/codes: Lot # PA02216; Exp. 12/2029 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
CareFusion 213, LLC: BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, T…
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Product, lots & distribution
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31. — Distribution: Nationwide inthe USA, as well as other foreign distribution. — Lots/codes: Lot # 3201277, Exp Date: 06/30/2026; Lot # 3213912, 3214206, 3214914, 3215710, 3227485, Exp Date: 07/31/2026; Lot # 3234036, 3234037, 3236460, 3237244, 3243095, 3263576, 3263580, 3264318, Exp Date: 08/31/2026; Lot # 3266655, 3266657, 3270586, 3278714, 3279949, 3282215, 3282956, Exp Date: 09/30/2026; Lot # 3299094, 3299684, 3302529, 3301463, 3309836, 3310556, 3312230, 3314562, Exp Date: 10/31/2026; Lot # 3321426, Exp Date: 11/30/2026; Lot # 3350974, 3352268, 3354120, 3354127, 3356911, 4003299, 4013168, Exp Date: 12/31/2026; Lot # 4023898, 4024208, 4024754, 4030686, 4031689, 4032182, 4032183, 4… — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
CareFusion 213, LLC: BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El…
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Product, lots & distribution
BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30. — Distribution: Nationwide inthe USA, as well as other foreign distribution. — Lots/codes: Lot # 3143780, 3151595, 3152898, 3152906, 3157235, 3158139, 3159803, 3166919, 3167620, 3191056, Exp Date: 05/31/2026; Lot # 3171115, 3172853, 3177820, 3193968, 3194750, 3199123, 3201195, 3206618, 3212202, 3213819, 3214876, Exp Date: 06/30/2026; Lot # 3222170, 3226846, 3228153, 3229867, 3228293, 3243337, Exp Date: 07/31/2026; Lot # 3230424, 3234042, 3240990, 3244469, 3249346, 3251278, 3254346, 3255678, 3258407, Exp Date: 08/31/2026; Lot # 3261058, 3263492, 3264573, 3268341, 3270418, 3275533, 3276460, 3278683, 3283037, 3284107, 3292960, 3292965, Exp Date: 09/30/2026; Lot # 3286221, 3290240, 329… — Status: Ongoing (voluntary: firm initiated)
Class IIFoodMay 28, 2026
Specialty Bakers, LLC: Vanilla Dessert Shells (Giant), 6 dessert shells/1 package, 1 dessert shell is approximately 23.67 grams. 1package is 142 grams. 1 package has 1 plastic tray which holds 6 dess…
Undeclared Allergen (Soy)
Product, lots & distribution
Vanilla Dessert Shells (Giant), 6 dessert shells/1 package, 1 dessert shell is approximately 23.67 grams. 1package is 142 grams. 1 package has 1 plastic tray which holds 6 desserts shells. Plastic is wrapped around 1 tray. 24 packs/Case. Frozen — Distribution: The adulterated product was distributed to the following states, Pennsylvania. — Lots/codes: Lot Number: 968674 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodMay 28, 2026
Wise Foods Inc: Wise Onion Rings, 3.75 oz, metalized film in cardboard cartons, 14 bags per case,
The product contains undeclared Yellow 5 and 6, Blue 1, and unapproved Red 3.
Product, lots & distribution
Wise Onion Rings, 3.75 oz, metalized film in cardboard cartons, 14 bags per case, — Distribution: The adulterated product was distributed to the following States: NC, VA, PA, NJ, NY, SC, FL — Lots/codes: UPC: 041262288874 Internal production number: 4228887 Lot Codes (expiration date): AUG0326, AUG1026, AUG1726 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 27, 2026
Lannett Company Inc.: Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46.
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Product, lots & distribution
Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46. — Distribution: Nationwide within the United States — Lots/codes: Lot #: 25282724A, Exp. Date 2027/01 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 27, 2026
Glenmark Pharmaceuticals Inc., USA: Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day re…
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Product, lots & distribution
Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day regimen, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430, NDC 68462-556-29 — Distribution: USA Nationwide. — Lots/codes: Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 27, 2026
Ajanta Pharma USA Inc: Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-056-03.
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Product, lots & distribution
Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-056-03. — Distribution: U.S. Nationwide — Lots/codes: Lot: PA00805, expires: 01/31/2029 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodMay 26, 2026
Nutricia North America: functional formularies LIQUID HOPE ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY NET WT. 12 OZ (341g) case UPC 8 57858 00453 3, package UPC 8 57858 00450 2
Subpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A than what is actually in the product.
Product, lots & distribution
functional formularies LIQUID HOPE ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY NET WT. 12 OZ (341g) case UPC 8 57858 00453 3, package UPC 8 57858 00450 2 — Distribution: Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT,… — Lots/codes: 24 count case with BEST IF USED BY DATES up to and including March 15, 2028 12 count package BEST IF USED BY DATES up to and including October 7, 2027 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodMay 26, 2026
Nutricia North America: functional formularies NOURISH ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY COMPLETE PLANT BASED NUTRITION NET WT. 12 OZ (341g) case UPC 8 57858 00445 8,…
Subpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A than what is actually in the product.
Product, lots & distribution
functional formularies NOURISH ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY COMPLETE PLANT BASED NUTRITION NET WT. 12 OZ (341g) case UPC 8 57858 00445 8, package UPC 8 57858 00447 2 — Distribution: Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT,… — Lots/codes: 24 count case with BEST IF USED BY DATES up to and including April 14, 2028 12 count package BEST IF USED BY DATES up to and including February 19, 2028 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 22, 2026
Zep Inc: Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc. Brand, Distributed by: Zap Inc., 350 Joe Frank Harris Parkway, SE, Emerson, GA 30137, N…
Microbial contamination of sterile products
Product, lots & distribution
Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc. Brand, Distributed by: Zap Inc., 350 Joe Frank Harris Parkway, SE, Emerson, GA 30137, NDC 66949-133-85. — Distribution: US Nationwide. — Lots/codes: Batch # E2612116, Exp Date: April 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 22, 2026
SUN PHARMACEUTICAL INDUSTRIES INC: Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by:…
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Product, lots & distribution
Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-762-10 — Distribution: Nationwide within the United States — Lots/codes: Lot #: AD93852, Exp Date: 06/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 22, 2026
SUN PHARMACEUTICAL INDUSTRIES INC: Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by:…
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Product, lots & distribution
Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-058-10 — Distribution: Nationwide within the United States — Lots/codes: Lot #: AE11393, Exp Date: 10/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIFoodMay 22, 2026
University of California Health Milk Bank: 001165: Standard Pasteurized Donor Human Milk; 100 mL bottles 001198: Pediatric Pasteurized Donor Human Milk; 200 mL bottles No UPC
Product is potentially contaminated with foreign material (plastic particles).
Product, lots & distribution
001165: Standard Pasteurized Donor Human Milk; 100 mL bottles 001198: Pediatric Pasteurized Donor Human Milk; 200 mL bottles No UPC — Distribution: Product is distributed to medical facilities and direct to consumer through medical facility. All facilities and consumers are located in CA. — Lots/codes: Expiration dates: 001165: 8/4/2026 001198: 10/31/2026 Lot Codes: 001165-1, 001165-2, 001165-3, 001165-4, 001165-5, 001165-6, 001165-7, 001165-8 001198-, 001198-2, 00198-3, 001198-4, 001198-5 — Status: Terminated (voluntary: firm initiated)
Class IIFoodMay 22, 2026
Boichik Bagels, Inc.: boichik bagels Whitefish Salad Ingredients: Smoked whitefish, mayonnaise (soybean oil, water, whole eggs and egg yolks, distilled vinegar, salt, sugar, lemon juice concentrate,…
Ingredient statement declares eggs, but eggs are omitted from the "contains" allergen statement on the product labels.
Product, lots & distribution
boichik bagels Whitefish Salad Ingredients: Smoked whitefish, mayonnaise (soybean oil, water, whole eggs and egg yolks, distilled vinegar, salt, sugar, lemon juice concentrate, calcium disodium edta, natural flavors), pickle juice, mustard, chives, black pepper. Contains: Fish — Distribution: Domestic: CA Foreign: Not applicable — Lots/codes: Sell By: 05-22-26, 05-23-26, 05-24-26, 05-25-26, 05-27-26, 05-28-26, 05-29-26, 05-30-26, 05-31-26, 06-01-26, 06-02-26, 06-03-26, 06-04-26 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodMay 22, 2026
Boichik Bagels, Inc.: boichik bagles Tuna Salad Ingredients: albacore tuna, mayonnaise (soybean oil, water, whole eggs and egg yolks, distilled vinegar, salt, sugar, lemon juice concentrate, calcium…
Ingredient statement declares eggs, but eggs are omitted from the "contains" allergen statement on the product labels.
Product, lots & distribution
boichik bagles Tuna Salad Ingredients: albacore tuna, mayonnaise (soybean oil, water, whole eggs and egg yolks, distilled vinegar, salt, sugar, lemon juice concentrate, calcium disodium edta, natural flavors), pickle juice, mustard, chives, black pepper. Contains: Fish — Distribution: Domestic: CA Foreign: Not applicable — Lots/codes: Sell By: 05-22-26, 05-23-26, 05-24-26, 05-25-26, 05-27-26, 05-28-26, 05-29-26, 05-30-26, 05-31-26, 06-01-26, 06-02-26, 06-03-26, 06-04-26 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodMay 22, 2026
Boichik Bagels, Inc.: boichik bagles Pumpernickel Mix Bagels 6 pre-sliced bagels NET WT 26.5 OZ (1.66 LB) 750g Ingredients: Organic wheat flour ... Contains Wheat Topped flavors may additionally cont…
Undeclared allergen, sesame.
Product, lots & distribution
boichik bagles Pumpernickel Mix Bagels 6 pre-sliced bagels NET WT 26.5 OZ (1.66 LB) 750g Ingredients: Organic wheat flour ... Contains Wheat Topped flavors may additionally contain ... sesame seeds ... Best by SE 26 26 UPC: 850016588067 — Distribution: Domestic: CA Foreign: Not applicable — Lots/codes: Best by: MAY 25 26, JUN 20 26, JUL 15 26, AUG 23 26, SE 26 26 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 21, 2026
Keystone Industries: Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Contents: 1 oz (3o g), Manufactured for: Pearson Dental Supply Inc., Sylmar, CA 91342 USA, NDC 43305-000…
Defective container:may contain bottles with incomplete seals
Product, lots & distribution
Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Contents: 1 oz (3o g), Manufactured for: Pearson Dental Supply Inc., Sylmar, CA 91342 USA, NDC 43305-0009-3. — Distribution: Nationwide in the USA — Lots/codes: BNZ-001917, Exp 04/01/2029 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 21, 2026
Keystone Industries: Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products, Made in USA for NDC Inc., 407 Sanford Road, Le…
Defective container:may contain bottles with incomplete seals
Product, lots & distribution
Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products, Made in USA for NDC Inc., 407 Sanford Road, Le Vergne, TN 37086, NDC 43128-034-30. — Distribution: Nationwide in the USA — Lots/codes: BNZ-001921, EXP 04/15/2029 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 21, 2026
Keystone Industries: DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured for and Distributed by Dental Health Products, Inc, 2614 North Sugar Bush Road, New Fran…
Defective container:may contain bottles with incomplete seals
Product, lots & distribution
DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured for and Distributed by Dental Health Products, Inc, 2614 North Sugar Bush Road, New Franken, WI 54229. NDC 69634-020-30 — Distribution: Nationwide in the USA — Lots/codes: BNZ-001921, EXP 04/15/2029 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 21, 2026
Keystone Industries: Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30
Defective container:may contain bottles with incomplete seals
Product, lots & distribution
Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30 — Distribution: Nationwide in the USA — Lots/codes: BNZ-001917, Exp 04/15/2029 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 21, 2026
Keystone Industries: Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g), Distributed by Dental City, 3205 Yeager Dr., Green Bay, WI 54311. NDC 69483-001-30
Defective container:may contain bottles with incomplete seals
Product, lots & distribution
Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g), Distributed by Dental City, 3205 Yeager Dr., Green Bay, WI 54311. NDC 69483-001-30 — Distribution: Nationwide in the USA — Lots/codes: BNZ-001921, Exp 04/15/2029 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 21, 2026
Keystone Industries: PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, Manufactured for PureLife LLC., Carson, CA 90810. NDC 68987-001…
Defective container:may contain bottles with incomplete seals
Product, lots & distribution
PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, Manufactured for PureLife LLC., Carson, CA 90810. NDC 68987-001-30 — Distribution: Nationwide in the USA — Lots/codes: BNZ-001921, EXP 04/15/2029 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 21, 2026
Keystone Industries: safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60099, Made in USA,…
Defective container:may contain bottles with incomplete seals
Product, lots & distribution
safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60099, Made in USA, NDC 67239-0223-1. — Distribution: Nationwide in the USA — Lots/codes: BNZ-001921, Exp 04/15/2029 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodMay 21, 2026
Fairhope Roasting Company: Fairhope Roasting Company Cold Brew Coffee Concentrate, packaged in 1-gallon plastic jugs, UPC 852236006062, for food service only
Product requires refrigeration but the label is missing a "Keep Refrigerated" statement
Product, lots & distribution
Fairhope Roasting Company Cold Brew Coffee Concentrate, packaged in 1-gallon plastic jugs, UPC 852236006062, for food service only — Distribution: Product distributed in AL for food service only — Lots/codes: Batch Number: 05/11/26, Expiration Date: 09/09/26 Batch Number: 05/12/26, Expiration Date: 09/10/26 Batch Number: 05/13/26, Expiration Date: 09/11/26 Batch Number: 05/14/26, Expiration Date: 09/12/26 — Status: Terminated (voluntary: firm initiated)
Class IIFoodMay 21, 2026
Alb-USA Enterprises Inc: El David Gelee, Bonbons with fruits Soft & Juicy, 400g. Packaged in decorated paperboard box and covered entirely in transparent, flexible plastic wrap. (20 bonbon pieces per…
Undeclared colors (FD&C Yellow 5 and FD&C Red 40).
Product, lots & distribution
El David Gelee, Bonbons with fruits Soft & Juicy, 400g. Packaged in decorated paperboard box and covered entirely in transparent, flexible plastic wrap. (20 bonbon pieces per 400g box). UPC 5304000050757 — Distribution: NY, NJ — Lots/codes: Expiration Date(s): 12.05.2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 19, 2026
Shimoga Chemicals: Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC 84849-000-01), b) 500 g (NDC 84849-000-02), (c) 100 g (NDC 84849-000-03), Rx Only, S…
cGMP deviations
Product, lots & distribution
Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC 84849-000-01), b) 500 g (NDC 84849-000-02), (c) 100 g (NDC 84849-000-03), Rx Only, Shimoga Chemicals Address -W-57A, MIDC Kupwad Samgli, Maharashtra, 416436, India. — Distribution: CA & FL only — Lots/codes: Lot #: a) CC/004/24-25, Exp Date September 2029; CC0032526, Exp. Date August 2030 b) CC0442526, Exp. Date Aug 2030; CC/005/24-25, Exp. Date November 2029 c) CC0032526, Exp. Date August 2030; CC/009/24-25, Exp. Date January 2030;CC/005/24-25, Exp. Date November 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIFoodMay 19, 2026
Rich Products Corp: Farm Rich Pizza Cheese Crunchers
May contain metal pieces
Product, lots & distribution
Farm Rich Pizza Cheese Crunchers — Distribution: TX, MD, MO, NY, AR, FL, NJ, TN, AL, OH, KY, PA, NC, SC, KS, MI, IA, IN, WI, GA, CA — Lots/codes: Lot/Unit Numbers: 003029976 Best by 7/30/27 UPC Codes: 041322652256 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 18, 2026
IntegraDose Compounding Services LLC: Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC. 3650 Victoria St N, Suite 900, Shoreview, MN, NDC 71139-0190-1.
Subpotent Drug
Product, lots & distribution
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC. 3650 Victoria St N, Suite 900, Shoreview, MN, NDC 71139-0190-1. — Distribution: U.S.A. Nationwide — Lots/codes: Lot#: 20260327VAS-3, BUD: 05/26/2026; 20260320VAS-3, BUD: 05/19/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 18, 2026
PReye LLC: PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO
Lack of Assurance of Sterility
Product, lots & distribution
PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO — Distribution: CO — Lots/codes: All lots within expiry — Status: Ongoing (voluntary: firm initiated)
Class IIFoodMay 18, 2026
International Food Products Corporation: Legacy Tex Dressing Stabilizer Blend #7604-50, 50lb bags
Product tested positive for Salmonella
Product, lots & distribution
Legacy Tex Dressing Stabilizer Blend #7604-50, 50lb bags — Distribution: TX, TN, OK — Lots/codes: Lot 26121A6A Item #502574 Use by 2027-05-04 — Status: Ongoing (voluntary: firm initiated)