Class IIMedicationJun 10, 2026
ACCORD BIOPHARMA INC: IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco corporate Drive, Suite 200, Raleigh, N…
Lack of assurance of Sterility:
Product, lots & distribution
IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco corporate Drive, Suite 200, Raleigh, NC 27617, USA, Manufactured at: Catalent Indiana, LLC, 1300 S. Patterson Drive, Bloomington, IN 47403, USA, NDC 69448-019-26. — Distribution: US Nationwide. — Lots/codes: Lot # 004L24A, Exp Date: 02/19/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 10, 2026
McKesson: Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Manufactured by: THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Gosla…
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
Product, lots & distribution
Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Manufactured by: THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany; Distributed by: Hikma, Berkeley Heights, NJ 07922. NDC: 0143-9341-01 — Distribution: Nationwide within the United States — Lots/codes: Lot #: CB0046, Exp. Date 06/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodJun 10, 2026
Fry Pie Factory LLC: Pepperoni Rolls, Net Wt. 5 oz (141g), individually packaged in a clear plastic bag, UPC 601959803041
Undeclared allergen (milk) and process deviation (product not held under refrigeration as required)
Product, lots & distribution
Pepperoni Rolls, Net Wt. 5 oz (141g), individually packaged in a clear plastic bag, UPC 601959803041 — Distribution: OH, WV — Lots/codes: Sell by dates 061226 through 062126 — Status: Completed (voluntary: firm initiated)
Class IIFoodJun 10, 2026
Wells Enterprises, Inc.: Plastic 1-gallon clear pail blue label which reads in part as "BLUE RIBBON CLASSICS FRENCH VANILLA, MFD. BY WELLS ENTERPRISES, INC. D/B/A WELLS DAIRY, INC., P.O. BOX 1310 LE…
Elevated coliforms
Product, lots & distribution
Plastic 1-gallon clear pail blue label which reads in part as "BLUE RIBBON CLASSICS FRENCH VANILLA, MFD. BY WELLS ENTERPRISES, INC. D/B/A WELLS DAIRY, INC., P.O. BOX 1310 LE MARS, IA 51031 — Distribution: One customer located in Kenosha, WI — Lots/codes: Pallet LPN: L7396434 Product lot code: 60003 JJJ 19115 18:00 6098 Best If Used By 10/07/27 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 8, 2026
ACCORD HEALTHCARE, INC.: Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: lntas Pharmace…
Subpotent Drug
Product, lots & distribution
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: lntas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-458-15. — Distribution: US Nationwide. — Lots/codes: Lot # D2401522, Exp Date: 06/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 8, 2026
Asclemed USA Inc.: Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-715-…
Lack of Assurance of Sterility
Product, lots & distribution
Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-715-01. — Distribution: USA Nationwide — Lots/codes: Lot #: AE3102, 121924X2, 022525X4, 033125X1, 030426X2, 033125X2, 041725X3, 061225X1, 072225X3, 080525X6, 080525X7, 080525X8, 091225X1, 100225X2, 100625X1, 122225X4, 010626X3, 041326X4, Exp 11/30/2026; AE5052, 041426X2, 041726X1, 051826X2, Exp 04/30/2028. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 8, 2026
Asclemed USA Inc.: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 85766-187-01.
Lack of Assurance of Sterility
Product, lots & distribution
Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 85766-187-01. — Distribution: USA Nationwide — Lots/codes: Lot #: AE3102, 031926L01, 032026A01, Exp 11/30/2026; AE5052, 052026G01, Exp 04/30/2028. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 7, 2026
ONESOURCE SPECIALTY PHARMA LIMITED: Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru - 561 203, India, Manufa…
Failed Impurities/Degradation Specifications
Product, lots & distribution
Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru - 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-893-31 — Distribution: Nationwide within the United States — Lots/codes: Lot #: 7000612A, Exp. Date 1/2028 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 5, 2026
Inventia Healthcare Limited: Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (Eas…
Failed Dissolution Specifications
Product, lots & distribution
Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (East) - 421506, INDIA. Distributed by: Risiong Pharma Holdings, Inc., East Brunswick, NJ 08816. NDC 100-tablet bottle: 64980-599-01; NDC 1000-tablet bottle: 64980-599-10 — Distribution: U.S. Nationwide. — Lots/codes: [100 tablet bottle] Batch RISA24001; [1000 tablet bottle] Batch RISB24002; Exp. 04/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodJun 5, 2026
Le Chef Bakery: Le Chef Bakery branded Mini Italian Pastry Assortment; 2.5 lbs/cs; (40 pieces/cs); packaged in generic food service packaging with white label. UPC: MP006
undeclared colors (yellow#5)
Product, lots & distribution
Le Chef Bakery branded Mini Italian Pastry Assortment; 2.5 lbs/cs; (40 pieces/cs); packaged in generic food service packaging with white label. UPC: MP006 — Distribution: Recalled products are intended for commercial and institution use. Examples are hotels, universities, and buisnesses in the south-west states of California, Arizona and Nevada. — Lots/codes: Julian Dates 3355 to 1536 (mfg. dates: 12/01/2025 to 06/02/2026) — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 4, 2026
Breckenridge Pharmaceutical, Inc.: Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, D…
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Product, lots & distribution
Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10 — Distribution: Nationwide within the United States — Lots/codes: Lot: 241180C, Exp. Date April 2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 4, 2026
Breckenridge Pharmaceutical, Inc.: Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutica…
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Product, lots & distribution
Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. — Distribution: Nationwide within the United States — Lots/codes: Lot: a) 241074C, Exp. Date May 2027; 240317, 240318, 240315C, 240373C, 240370C, 240375C, 240413C, Exp. Date February 2027; 240316,Exp. Date January 2027; 232311, Exp. Date November 2026; b) 240978C, 241052C, Exp. Date April 2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 4, 2026
Amgen, Inc.: Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC 55513-800-60), Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made…
Presence of Foreign Substance.
Product, lots & distribution
Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC 55513-800-60), Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. — Distribution: Nationwide within the United States — Lots/codes: a) Lot # 1138901, Exp. Date 08/31/2026; 1149846, Exp. Date 04/30/2027 b) Lot #1138201, 1138202, 08/31/2026, 1138900, 1141143, Exp. Date 08/31/2026; 1140280, 1140281, 1142063, Exp. Date 10/31/2026; 1142062, 1142942, 1142943, Exp. Date 11/30/2026; 1144081, 1144104, Exp. Date 12/31/2026; 1146373, 1146374, Exp. Date 01/31/2027; 1147491, 1147492, 1149843, Exp. Date 03/31/2027; 1151113, 1151890, 1153401, Exp. Date 07/31/2027; 1151114, 1151115, Exp. Date 09/30/2027; 1152412, 1153399, 1153400, Exp. Date 06/30/2027; 1155834, 1155835, Exp. Date 04/30/2027; 1155836, Exp. Date 09/30/2027; 1158480, 115848… — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 4, 2026
Amgen, Inc.: Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-073-30
CGMP Deviations
Product, lots & distribution
Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-073-30 — Distribution: Nationwide within the United States — Lots/codes: Lot#: 1156858, Exp. Date 12/31/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 4, 2026
Amgen, Inc.: Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-074-30
CGMP Deviations
Product, lots & distribution
Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-074-30 — Distribution: Nationwide within the United States — Lots/codes: Lot #: 1157055, Exp. Date 1/31/2028 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 4, 2026
Amgen, Inc.: Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60
Presence of Foreign Substance.
Product, lots & distribution
Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60 — Distribution: Nationwide within the United States — Lots/codes: Lot #: 1138203, 1142065, Exp. Date 07/31/2026; 1145151, 1145152, 1145153, Exp. Date 2/28/2027; 1148908, 1148909, Exp. Date 05/31/2027; 1162845, 1162846, Exp. Date 11/30/2027; 1166471, 1166472, 1166473, Exp. Date 05/31/2028; 1170615, Exp. Date 08/31/2028 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 4, 2026
Amgen, Inc.: Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks, CA 91320-1799, Made in Japan. NDC 55513-075-30
CGMP Deviations
Product, lots & distribution
Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks, CA 91320-1799, Made in Japan. NDC 55513-075-30 — Distribution: Nationwide within the United States — Lots/codes: Lot #: 1157056, Exp. Date 02/29/2028 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 4, 2026
Annora Pharma Private Limited: Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangana, India, Manufactured for: Camber Pharmaceutica…
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
Product, lots & distribution
Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangana, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-813-60. — Distribution: Nationwide in the USA — Lots/codes: Lot: A253999, A254000, Expires: 09/30/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 4, 2026
Elevate Oral Care: Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Beach, FL 33411, NDC 57511-0611-1.
sub potency
Product, lots & distribution
Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Beach, FL 33411, NDC 57511-0611-1. — Distribution: Nationwide — Lots/codes: Lots PO062402, Exp Date 6/30/2026, PO072401, Exp Date 7/30/2026, PO092401, Exp Date 9/30/2026, PO102401, Exp Date 10/31/2026 & PO102402, Exp Date 10/31/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 4, 2026
Lupin Pharmaceuticals Inc.: prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL (70748-332-04), Manufactured by: L…
Presence of Foreign Substance
Product, lots & distribution
prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL (70748-332-04), Manufactured by: Lupin Limited, Pithampur (M.P) 454 775, INDIA — Distribution: U.S. Nationwide — Lots/codes: Lots: a) HA00937, HA00939, HA00941, HA00971, H00973, HA00975, Expires: 7/31/2026; HA00987, HA00989, HA00991, HA01010, HA01012, HA01014, HA01016, HA01048, Expires: 8/31/2026; HA01120, HA01137, HA01129, HA01138, HA01133, Expires: 9/30/2026; HA01148, HA01196, HA01198, HA01200, HA01206, HA01208, HA01210, HA01212, HA01214, HA01216, HA01218, HA01220, Expires: 10/31/2026; HA01236, HA01238, HA01240, HA01244, HA01246, HA01248, HA01261, HA01263, HA01265, HA01267, HA01278, HA01280, HA01282, HA01284, HA01288, HA01290, HA01292, HA01298, Expires: 11/30/2026; HB00002, HB00004, HB00006, HB00017, HB00019, HB0… — Status: Ongoing (voluntary: firm initiated)
Class IIFoodJun 4, 2026
W.Y. Industries, Inc.: WY Duck Sauce, 0.35 oz. (10 g), flexible film packets, 500 packets per case.
Product may contain metal fragments.
Product, lots & distribution
WY Duck Sauce, 0.35 oz. (10 g), flexible film packets, 500 packets per case. — Distribution: The adulterated product was distributed to the following states : NY, NJ, OH, PA — Lots/codes: UPC codes: 015051010021 Lot code*: 152, after 15:00; 153, any time — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Central Admixture Pharmacy Services, Inc.: Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume 1295 mL per bag, Rx only, Single Dos…
Incorrect product formulation: bag did not contain copper and famotidine per label.
Product, lots & distribution
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume 1295 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Boston, 55 6th Rd Woburn, Massachusetts 01801-1767. — Distribution: MA — Lots/codes: 24-1269856-0-1 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Dabur India Limited: Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt. 1.5 oz (42.5g) Tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10…
CGMP Deviations; deficiencies observed during FDA inspection
Product, lots & distribution
Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt. 1.5 oz (42.5g) Tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829 10461 5. — Distribution: US Nationwide. — Lots/codes: Lot# 0001, 0002, within expiry — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Dabur India Limited: Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 units, neomycin sulphate 3.5 mg, polymyxin B sulphate 5000 units, Net Wt. 0.5 oz (14g) tubes, Manufact…
CGMP Deviations; deficiencies observed during FDA inspection
Product, lots & distribution
Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 units, neomycin sulphate 3.5 mg, polymyxin B sulphate 5000 units, Net Wt. 0.5 oz (14g) tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829 10372 4. — Distribution: US Nationwide. — Lots/codes: Lot# 0002, Lot# 0003, within expiry — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Dabur India Limited: Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g) tubes, Product manufactured…
CGMP Deviations; deficiencies observed during FDA inspection
Product, lots & distribution
Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g) tubes, Product manufactured for Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC 1 94283 65181 0. — Distribution: US Nationwide. — Lots/codes: Lot# 0001, and Lot# 0005, within expiry — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Dabur India Limited: Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g), Product distributed…
CGMP Deviations; deficiencies observed during FDA inspection
Product, lots & distribution
Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g), Product distributed by: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC 3 66715 97310 8. — Distribution: US Nationwide. — Lots/codes: Lot# 0005, within expiry — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Dabur India Limited: Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 3.5 mg, Polymyxin-B Sulfate 5,000 units, net wt. 2oz (57g) tubes, Distributed by/por: P…
CGMP Deviations; deficiencies observed during FDA inspection
Product, lots & distribution
Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 3.5 mg, Polymyxin-B Sulfate 5,000 units, net wt. 2oz (57g) tubes, Distributed by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 10096 77162 9. — Distribution: US Nationwide. — Lots/codes: Lot# 0004, within expiry — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Dabur India Limited: Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 52924 00683 1.
CGMP Deviations; deficiencies observed during FDA inspection
Product, lots & distribution
Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 52924 00683 1. — Distribution: US Nationwide. — Lots/codes: Lot# 0003, within expiry — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Dabur India Limited: Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 count box, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UP…
CGMP Deviations; deficiencies observed during FDA inspection
Product, lots & distribution
Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 count box, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30352 4. — Distribution: US Nationwide. — Lots/codes: Lot# 007, 008, 009, 015, 016, Within Expiry. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Dabur India Limited: Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30354 8.
CGMP Deviations; deficiencies observed during FDA inspection
Product, lots & distribution
Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30354 8. — Distribution: US Nationwide. — Lots/codes: Lot# 001, 002, 003, 004, 005, 006, 010, 011, 012, 013, 014, 016, 017, 018, 019, 020, Within Expiry. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Dabur India Limited: Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC X004WB4LK…
CGMP Deviations; deficiencies observed during FDA inspection
Product, lots & distribution
Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC X004WB4LKT. — Distribution: US Nationwide. — Lots/codes: Lot# 022, 023 ,024, Within Expiry. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Dabur India Limited: Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 524103 0244 2.
CGMP Deviations; deficiencies observed during FDA inspection
Product, lots & distribution
Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 524103 0244 2. — Distribution: US Nationwide. — Lots/codes: Lot# 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, Within Expiry. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Dabur India Limited: Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 305061.
CGMP Deviations; deficiencies observed during FDA inspection
Product, lots & distribution
Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 305061. — Distribution: US Nationwide. — Lots/codes: Lot# 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 014, 015, 017, 018, 019, 020, 021, 022, 023, 024, 025, 026, 027, 028, 029, 030, 034, 035, 036, 037, 038, 039, 041, 042, 043, 044, 048, 049, 050, 051, 052, 053, 054, 055, 056, 057, 058, 059, 060, 061, 062, 063, 064, Within Expiry. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Dabur India Limited: Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30503 0.
CGMP Deviations; deficiencies observed during FDA inspection
Product, lots & distribution
Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30503 0. — Distribution: US Nationwide. — Lots/codes: Lot# 001, 002, 013, 016, 031, 032, 033, 045, 046, 047, Within Expiry. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Dabur India Limited: Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units), Neomycin Sulfate 5 mg, Polymixin B 5000 units, 0.9g packets, 144 packets per box, 130g, Manufact…
CGMP Deviations; deficiencies observed during FDA inspection
Product, lots & distribution
Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units), Neomycin Sulfate 5 mg, Polymixin B 5000 units, 0.9g packets, 144 packets per box, 130g, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 1 03 52410 30253 1. — Distribution: US Nationwide. — Lots/codes: Lot# 011, 014, 015, 016, 017, 018, 019, 020, 021, 022, 026, Within Expiry. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Dabur India Limited: Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 5 mg, Polymyxin B 5000 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Roa…
CGMP Deviations; deficiencies observed during FDA inspection
Product, lots & distribution
Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 5 mg, Polymyxin B 5000 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30255 8. — Distribution: US Nationwide. — Lots/codes: Lot# 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 012, 013, 023, 024, 025, 027, 028, 029, 031, 032, 033, 034, 035, Within Expiry. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 1, 2026
Ascend Laboratories, LLC: Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratori…
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Product, lots & distribution
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-644-30 — Distribution: Nationwide in the USA — Lots/codes: Lot# 25141635, Exp 4/30/2028 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 29, 2026
Golden State Medical Supply Inc.: GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett,…
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
Product, lots & distribution
GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett, Inc., Seymour, IN 47274, Packaged by GSMS Incorporated, Camarillo, CA 93012. NDC 51407-268-90. — Distribution: Within the U.S Market. — Lots/codes: Lots: GS065128, GS065844, GS066695, GS067432, GS067993, expires: 01/31/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 29, 2026
SUN PHARMACEUTICAL INDUSTRIES INC: Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Distributed by: Sun Pharmac…
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
Product, lots & distribution
Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Baska Ujeti Road, Ujeti Halol-289350, Gujarat, India, NDC 47335-633-49. — Distribution: Nationwide within the United States — Lots/codes: Lot #: BAG0074A, Exp. Date: 1/31/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 29, 2026
Gasco Industrial Corp.: Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL). Manufactured by: Gasco Industrial Corp., PO Box 1360 Gurabo PR 00778 Made in USA UPC 7 87302 13044 3
Subpotent drug
Product, lots & distribution
Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL). Manufactured by: Gasco Industrial Corp., PO Box 1360 Gurabo PR 00778 Made in USA UPC 7 87302 13044 3 — Distribution: Nationwide within the US — Lots/codes: Lot 250306B3, within expiry — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 29, 2026
Gasco Industrial Corp.: Gasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.78 L), Manufactured by: Gasco Industrial Corp., PO Box 1360, Gurabo, PR 00778, Made in USA
Subpotent drug
Product, lots & distribution
Gasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.78 L), Manufactured by: Gasco Industrial Corp., PO Box 1360, Gurabo, PR 00778, Made in USA — Distribution: Nationwide within the US — Lots/codes: Lots 250108A2, 250109A1, 250115A1, 250124A1, 250213A1, 250220Z3, 250221A3, 250221A4, 250224A1, 250303A3, 250306A1, 250307A1, within expiry — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 29, 2026
Gasco Industrial Corp.: Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo PR 00778, UPC 7 87302 12363 6.
Subpotent drug
Product, lots & distribution
Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo PR 00778, UPC 7 87302 12363 6. — Distribution: Nationwide within the US — Lots/codes: Lot 250218B3, within expiry — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 29, 2026
Gasco Industrial Corp.: Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 1 gallon (3.78 liter), Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924
Subpotent drug
Product, lots & distribution
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 1 gallon (3.78 liter), Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924 — Distribution: Nationwide within the US — Lots/codes: Lots 250221A5, 250224A2 within expiry — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 29, 2026
Gasco Industrial Corp.: Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 16 oz, 474 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924, UPC 69685696529
Subpotent drug
Product, lots & distribution
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 16 oz, 474 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924, UPC 69685696529 — Distribution: Nationwide within the US — Lots/codes: Lots 250109B1, 250110B1, 250228B1, 250303B1, 250304B1, 250305B1, 250306B1, 250306B2 within expiry — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 29, 2026
Gasco Industrial Corp.: Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana Llana Rio Piedras, PR 00924, UPC 659685696…
Subpotent drug
Product, lots & distribution
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana Llana Rio Piedras, PR 00924, UPC 659685696567. — Distribution: Nationwide within the US — Lots/codes: Lots 250206B1, 250218B2, 250507B1, within expiry — Status: Ongoing (voluntary: firm initiated)
Class IIFoodMay 29, 2026
Champion Foods, LLC: Motor City Pizza Co. 5 Cheese Bread Single retail pack; 22.43 oz. (1 lb. 6.4 oz.) 636g UPC 8 70375 00511 1; 6 retail units per case Motor City Pizza Co. 5 Cheese Bread Twin retai…
potential salmonella contamination
Product, lots & distribution
Motor City Pizza Co. 5 Cheese Bread Single retail pack; 22.43 oz. (1 lb. 6.4 oz.) 636g UPC 8 70375 00511 1; 6 retail units per case Motor City Pizza Co. 5 Cheese Bread Twin retail pack; 44.86 oz. (2 lb. 12.9 oz.) 1272g UPC 8 70375 00509 8; 10 retail units per case — Distribution: Affected 5 Cheese Bread lots were distributed and sold nationwide at retailers including Costco, Walmart, Giant Landover, Grocery Outlet, Jewel, Kroger, Schnucks, Target, C&S, Bozzuto s, Brookshire Grocery, Meijer, Food City, KeHe, Lipari,… — Lots/codes: Sell By dates: Single retail pack: 2/4/2027, 2/5/2027, 2/23/2027, 2/24/2027, 3/9/2027, 3/10/2027, 3/17/2027, 3/18/2027, 3/24/2027, 3/25/2027, 4/7/2027, 4/8/2027, 4/20/2027, 4/21/2027 Twin retail pack: 2/3/2027, 2/4/2027, 2/24/2027, 2/25/2027, 3/10/2027, 3/11/2027, 3/18/2027, 3/25/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: KIRKLAND Signature, ULTRA STRENGTH ANTACID, Calcium Carbonate, 1000 mg, 265-count bottle, MANUFACTURED BY: GUARDIAN DRUG COMPANY, INC., 2 CHARLES COURT/DAYTON, NJ 08810, FOR:…
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
KIRKLAND Signature, ULTRA STRENGTH ANTACID, Calcium Carbonate, 1000 mg, 265-count bottle, MANUFACTURED BY: GUARDIAN DRUG COMPANY, INC., 2 CHARLES COURT/DAYTON, NJ 08810, FOR: Costco Wholesale Corporation, 999 Lake Drive, Issaquah, WA 98027, NDC 63981-171-80 — Distribution: U.S.A. Nationwide — Lots/codes: Lot#: 1716059, 1716060, 1716061, 1716062, 1716063, 1716218, 1716219, 1716228, 1716229, 1716238, Exp 2/28/2029; 1716258, Exp 3/31/2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-count bottle, Haleon, Warren, NJ 07059, UPC 3 07660 74610 2.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-count bottle, Haleon, Warren, NJ 07059, UPC 3 07660 74610 2. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1096075, 1096076, 1096077, 1096078, Exp 1/31/2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 750 mg, 330-count bottle, Haleon, Warren, NJ 07059, UPC 3 0766 3072 10 9.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 750 mg, 330-count bottle, Haleon, Warren, NJ 07059, UPC 3 0766 3072 10 9. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1076169, Exp 2/28/2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 750 mg, chewable, 96-count bottle, Distributed by: Amerisourcebergen, 1 West First Avenue, Conshohocken, PA, 1…
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 750 mg, chewable, 96-count bottle, Distributed by: Amerisourcebergen, 1 West First Avenue, Conshohocken, PA, 19428, NDC 24385-106-80. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276118, Exp 1/31/2029. — Status: Ongoing (voluntary: firm initiated)