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.

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

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)

D-0612-2026 · 934577 bottles

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)

D-0613-2026 · 9565 bottles

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)

D-0614-2026 · N/A

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)

D-0615-2026 · N/A

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)

D-0616-2026 · N/A

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)

D-0626-2026 · 31,392 60-count bottles

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)

D-0627-2026 · 8132 6-packs & 2262 2-packs

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)

D-0655-2026 · 2,530,182 bottles

Class IIIMedicationJun 3, 2026

Amneal Pharmaceuticals, LLC: Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distri…

Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.

Product, lots & distribution

Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01 — Distribution: Nationwide within the USA. — Lots/codes: Lot AM251676, EXP 11/31/2028 — Status: Ongoing (voluntary: firm initiated)

D-0585-2026 · 27,936 100-count bottles

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)

D-0618-2026 · One (1) patient-specific TPN prescription.

Class IIIMedicationJun 2, 2026

ANI Pharmaceuticals, Inc.: hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10

Presence of foreign substance

Product, lots & distribution

hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10 — Distribution: Nationwide in the USA — Lots/codes: Lot S25133A — Status: Ongoing (voluntary: firm initiated)

D-0619-2026 · 6564 bottles

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)

D-0629-2026 · 1102 tubes

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)

D-0630-2026 · 2503 tubes

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)

D-0631-2026 · 2420 tubes

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)

D-0632-2026 · 1225 tubes

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)

D-0633-2026 · 84 tubes

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)

D-0634-2026 · 84 tubes

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)

D-0635-2026 · 1087 tubes

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)

D-0636-2026 · 4374 tubes

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)

D-0637-2026 · 1185 tubes

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)

D-0638-2026 · 5755 tubes

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)

D-0639-2026 · 4,738 tubes

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)

D-0640-2026 · 4,944 tubes

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)

D-0641-2026 · 3006 tubes

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)

D-0642-2026 · 8996 tubes

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)

D-0597-2026 · 360 30-count bottles

Class IIIMedicationJun 1, 2026

Sandoz Inc: Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504. NDC: 66758-235-31

Labeling: Incorrect or Missing Lot and/or Exp Date

Product, lots & distribution

Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504. NDC: 66758-235-31 — Distribution: U.S. Nationwide — Lots/codes: Lot VA0099422; Exp. Date June 30, 2028 — Status: Ongoing (voluntary: firm initiated)

D-0608-2026 · 7,803 bottles

Class IMedicationJun 1, 2026

BEEKEEPER'S NATURALS USA INC.: BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis + Xylitol, 1 FL OZ (30 mL) per bottle, Manufactured For: Beekeeper's Naturals USA In…

Microbial Contamination of Non-Sterile Products

Product, lots & distribution

BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis + Xylitol, 1 FL OZ (30 mL) per bottle, Manufactured For: Beekeeper's Naturals USA Inc., Covina, CA 91789. — Distribution: Nationwide within the United States. — Lots/codes: Lot #: 5950, Exp. Date 02/2028 — Status: Ongoing (voluntary: firm initiated)

D-0620-2026 · 1680 bottles

Class IIIMedicationJun 1, 2026

SUN PHARMACEUTICAL INDUSTRIES INC: Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901. NDC 66336-56…

Failed Impurities/Degradation Specifications

Product, lots & distribution

Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901. NDC 66336-561-30 — Distribution: U.S. Nationwide — Lots/codes: Lot, expiry: Lot DNG0283A, exp 03/31/2027; Lots DNF0922A and DNF0923B, exp 10/31/2026 — Status: Ongoing (voluntary: firm initiated)

D-0654-2026 · 9,048 bottles

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)

D-0587-2026 · 2,961 bottles

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)

D-0607-2026 · N/A

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)

D-0665-2026 · N/A

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)

D-0666-2026 · N/A

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)

D-0667-2026 · N/A

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)

D-0668-2026 · N/A

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)

D-0669-2026 · N/A

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)

D-0670-2026 · N/A

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)

D-0557-2026

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)

D-0558-2026

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)

D-0559-2026

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)

D-0560-2026

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)

D-0561-2026

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)

D-0562-2026

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)

D-0563-2026

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)

D-0564-2026

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)

D-0565-2026

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)

D-0566-2026

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)

D-0567-2026

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)

D-0568-2026

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)

D-0569-2026

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