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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 361–380 of 18,047 drug recalls

Drug Recall Ongoing 2026 recordClass II

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

by Guardian Drug Co. Inc.

Reason
Presence of foreign substance: small metallic particles in chewable tablets.
Recall initiated
May 28, 2026
Reported by FDA
June 10, 2026
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30.

by Ascend Laboratories, LLC

Reason
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Recall initiated
May 5, 2026
Reported by FDA
June 10, 2026
Distribution
U.S.A. Nationwide

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Drug Recall Ongoing 2026 recordClass II

Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.

by Asclemed USA Inc.

Reason
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Recall initiated
May 14, 2026
Reported by FDA
June 10, 2026
Distribution
US Nationwide.

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Drug Recall Ongoing 2026 recordClass II

Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.

by Spectra Medical Devices, Llc

Reason
Lack of Assurance of Sterility
Recall initiated
May 12, 2026
Reported by FDA
June 10, 2026
Distribution
USA Nationwide

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Drug Recall Ongoing 2026 recordClass III

Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520. NDC: 55150-164-02

by Eugia US LLC

Reason
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Recall initiated
May 18, 2026
Reported by FDA
June 10, 2026
Distribution
US Nationwide.

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Drug Recall Ongoing 2026 recordClass III

PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10.

by AbbVie Inc.

Reason
Failed Stability Specifications
Recall initiated
May 18, 2026
Reported by FDA
June 3, 2026
Distribution
US Nationwide.

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Drug Recall Ongoing 2026 recordClass III

Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88.

by AVEVA Drug Delivery Systems, Inc.

Reason
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Recall initiated
May 14, 2026
Reported by FDA
June 3, 2026
Distribution
Nationwide within the U.S

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Drug Recall Ongoing 2026 recordClass I

MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: Pharmacal 1 Pharmacal Way, P.O. Box 198, Jackson, WI 53037.

by Wisconsin Pharmacal Company

Reason
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
Recall initiated
April 24, 2026
Reported by FDA
May 27, 2026
Distribution
USA Nationwide and Bahamas

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Drug Recall Ongoing 2026 recordClass II

Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syringe, (Nephronex), Mfg By: LLORENS; Pkg by: Safecor, Columbus, OH. NDC 54859-0516-08

by Safecor Health, LLC

Reason
Presence of a Foreign Substance; black particles observed in liquid
Recall initiated
May 1, 2026
Reported by FDA
May 27, 2026
Distribution
OH

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Drug Recall Ongoing 2026 recordClass II

fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, MN, NDC 71139-6030-1.

by IntegraDose Compounding Services LLC

Reason
Subpotent Drug
Recall initiated
May 12, 2026
Reported by FDA
May 27, 2026
Distribution
Nationwide.

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Drug Recall Ongoing 2026 recordClass II

cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manufactured by: UCB Inc., Smyrna, GA 30080, a) NDC 50474-710-79, b) Professional sample, NDC 50474-710-80; c) 3 cartons, STARTER KIT, NDC 50474-710-81.

by UCB Biosciences Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
May 8, 2026
Reported by FDA
May 27, 2026
Distribution
US Nationwide.

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Drug Recall Ongoing 2026 recordClass II

Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; (NDC 70710-1048-3).

by Zydus Pharmaceuticals (USA) Inc

Reason
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Recall initiated
April 29, 2026
Reported by FDA
May 27, 2026
Distribution
Nationwide within the U.S

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Drug Recall Ongoing 2026 recordClass II

Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; a) 30 count bottles (NDC 70710-1047-3); b) 100 count bottles (NDC 70710-1047-1).

by Zydus Pharmaceuticals (USA) Inc

Reason
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Recall initiated
April 29, 2026
Reported by FDA
May 27, 2026
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing 2026 recordClass II

Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20

by ANI Pharmaceuticals, Inc.

Reason
Defective Container; packets were found to be either empty or partially full.
Recall initiated
May 12, 2026
Reported by FDA
May 27, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.

by Haleon US Holdings LLC

Reason
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Recall initiated
May 11, 2026
Reported by FDA
May 27, 2026
Distribution
U.S. Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02; b) 3 Pens - NDC 70748-346-03.

by Lupin Pharmaceuticals Inc.

Reason
Presence of particulate matter: a white thread-like structure in the cartridge
Recall initiated
April 24, 2026
Reported by FDA
May 27, 2026
Distribution
Nationwide within U.S

View recall →

Drug Recall Ongoing 2026 recordClass III

Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.

by Sagent Pharmaceuticals

Reason
Failed Impurities/Degradation Specifications
Recall initiated
May 4, 2026
Reported by FDA
May 27, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-01

by Safecor Health, LLC

Reason
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Recall initiated
April 30, 2026
Reported by FDA
May 27, 2026
Distribution
TX only

View recall →

Drug Recall Ongoing 2026 recordClass III

Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11

by Amerisource Health Services LLC

Reason
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Recall initiated
May 1, 2026
Reported by FDA
May 27, 2026
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass III

Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11

by Amerisource Health Services LLC

Reason
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Recall initiated
May 1, 2026
Reported by FDA
May 27, 2026
Distribution
USA Nationwide

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.

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