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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 221–240 of 17,898 drug recalls

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.

View recall →

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

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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.

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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

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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

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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

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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

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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

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Drug Recall Ongoing 2026 recordClass III

Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-638-01

by Golden State Medical Supply Inc.

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

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Drug Recall Ongoing 2026 recordClass III

Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-637-05

by Golden State Medical Supply Inc.

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

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Drug Recall Ongoing 2026 recordClass III

Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.

by Lannett Company Inc.

Reason
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Recall initiated
April 24, 2026
Reported by FDA
May 27, 2026
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-590-01.

by Ascend Laboratories, LLC

Reason
Failed Dissolution Specifications
Recall initiated
April 27, 2026
Reported by FDA
May 20, 2026
Distribution
U.S. Nationwide

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Drug Recall Ongoing 2026 recordClass II

Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.

by ENDO USA, Inc.

Reason
Crystallization; identified as Buprenorphine free base
Recall initiated
March 13, 2026
Reported by FDA
May 20, 2026
Distribution
USA Nationwide

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Drug Recall Ongoing 2026 recordClass II

Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical, Inc., 514 S. Vermont Ave., Glendora, CA 91741, USA, Made in France, NDC 42126-6400-1.

by Oasis Medical, Inc.

Reason
Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
Recall initiated
April 27, 2026
Reported by FDA
May 20, 2026
Distribution
Nationwide within the United States

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Drug Recall Ongoing 2026 recordClass I

Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07.

by B BRAUN MEDICAL INC

Reason
Presence of Particulate Matter.
Recall initiated
April 28, 2026
Reported by FDA
May 13, 2026
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90670

by Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles

Reason
Incorrect Product Formulation: product did not contain insulin as listed in the label.
Recall initiated
December 27, 2025
Reported by FDA
May 13, 2026
Distribution
CA

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Drug Recall Ongoing 2026 recordClass II

NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16

by Acella Pharmaceuticals, LLC

Reason
Chemical contamination; presence of lead and lithium above specification
Recall initiated
April 20, 2026
Reported by FDA
May 13, 2026
Distribution
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.