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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 21–40 of 17,898 drug recalls

Drug Recall Ongoing 2026 recordClass II

SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-495-05

by Apollo Care, LLC

Reason
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Recall initiated
July 29, 2026
Reported by FDA
August 19, 2026
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing 2026 recordClass II

Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 0078-0359-34

by Novartis Pharmaceuticals Corporation

Reason
Failed Dissolution Specifications
Recall initiated
August 4, 2026
Reported by FDA
August 19, 2026
Distribution
US Nationwide

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Drug Recall Ongoing 2026 recordClass II

Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1159-3.

by Zydus Pharmaceuticals (USA) Inc

Reason
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Recall initiated
August 5, 2026
Reported by FDA
August 12, 2026
Distribution
Nationwide in the USA

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Drug Recall Ongoing 2026 recordClass I

Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8114-1

by Sunny Pharmtech Inc.

Reason
Presence of Particulate Matter; identified as stainless steel
Recall initiated
July 17, 2026
Reported by FDA
August 12, 2026
Distribution
USA Nationwide

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Drug Recall Ongoing 2026 recordClass I

Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8112-1

by Sunny Pharmtech Inc.

Reason
Presence of Particulate Matter; identified as stainless steel
Recall initiated
July 17, 2026
Reported by FDA
August 12, 2026
Distribution
USA Nationwide

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Drug Recall Ongoing 2026 recordClass III

Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Inc., Atlanta, 1750 Corp Dr. Ste 725, Norcross, GA 30093 (844) 903-6418

by Central Admixture Pharmacy Services Inc

Reason
Incorrect Product Formulation
Recall initiated
July 16, 2026
Reported by FDA
August 12, 2026
Distribution
GA only

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Drug Recall Ongoing 2026 recordClass II

Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-719-99

by Aurobindo Pharma USA Inc

Reason
shortfill; reports of empty capsules.
Recall initiated
July 23, 2026
Reported by FDA
August 12, 2026
Distribution
US Nationwide.

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Drug Recall Ongoing 2026 recordClass III

Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.

by Ascend Laboratories, LLC

Reason
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Recall initiated
July 16, 2026
Reported by FDA
August 5, 2026
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass III

Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-68.

by Ascend Laboratories, LLC

Reason
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Recall initiated
July 16, 2026
Reported by FDA
August 5, 2026
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass III

Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7255-68.

by Ascend Laboratories, LLC

Reason
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Recall initiated
July 16, 2026
Reported by FDA
August 5, 2026
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386-00.

by MYLAN PHARMACEUTICALS INC

Reason
Presence of precipitate
Recall initiated
July 2, 2026
Reported by FDA
August 5, 2026
Distribution
USA Nationwide

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Drug Recall Ongoing 2026 recordClass II

Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Recall initiated
July 23, 2026
Reported by FDA
August 5, 2026
Distribution
Nationwide within the United States.

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Drug Recall Ongoing 2026 recordClass II

Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manufactured by: Micro Labs Limited, India, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873. NDC 42571-147-26.

by MICRO LABS USA INC

Reason
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Recall initiated
July 22, 2026
Reported by FDA
August 5, 2026
Distribution
Nationwide in the USA.

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Drug Recall Ongoing 2026 recordClass III

Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-101-30.

by Supernus Pharmaceuticals, Inc.

Reason
Failed Dissolution Specifications
Recall initiated
July 6, 2026
Reported by FDA
July 29, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, Made in India, NDC 69452-435-30.

by Bionpharma Inc.

Reason
Presence of Foreign Tablets/Capsules
Recall initiated
June 26, 2026
Reported by FDA
July 29, 2026
Distribution
US Nationwide.

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Drug Recall Ongoing 2026 recordClass II

Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes, NDCs 68094-073-01 (oral syringe) and 68094-073-58 (case).

by Precision Dose Inc.

Reason
Failed Impurities/Degradation Specifications
Recall initiated
July 14, 2026
Reported by FDA
July 29, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass III

Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10.

by Ascend Laboratories, LLC

Reason
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Recall initiated
June 30, 2026
Reported by FDA
July 29, 2026
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass III

Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68.

by Ascend Laboratories, LLC

Reason
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Recall initiated
June 30, 2026
Reported by FDA
July 29, 2026
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass I

Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-401-10.

by JB Chemicals and Pharmaceuticals Ltd

Reason
Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
Recall initiated
June 24, 2026
Reported by FDA
July 29, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial: 63323-485-03

by Fresenius Kabi USA, LLC

Reason
Presence of Particulate Matter: Hair was found in products
Recall initiated
July 16, 2026
Reported by FDA
July 29, 2026
Distribution
Nationwide within in the USA

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.