Skip to main content

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.

Filters
Recall details
Location
Date range
Clear filters

Showing 1,281–1,300 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-079-93

by Viatris Inc

Reason
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Recall initiated
December 23, 2024
Reported by FDA
January 22, 2025
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC: 60687-480-21, Unit Dose NDC: 60687-480-11

by Amerisource Health Services LLC

Reason
Failed Dissolution Specifications:
Recall initiated
December 17, 2024
Reported by FDA
January 22, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-11

by Amerisource Health Services LLC

Reason
Presence of Foreign Tablets/Capsules
Recall initiated
January 7, 2025
Reported by FDA
January 22, 2025
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass I

Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134

by Alcon Research LLC

Reason
Non-Sterility
Recall initiated
December 18, 2024
Reported by FDA
January 22, 2025
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass III

Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46, Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8026-02.

by Akron Pharma, Inc.

Reason
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Recall initiated
December 12, 2024
Reported by FDA
January 22, 2025
Distribution
Nationwide in the US

View recall →

Drug Recall Ongoing Historical recordClass III

Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E., Suite 117, Fairfield, NJ 07004, NDC 71399-8028-2.

by Akron Pharma, Inc.

Reason
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Recall initiated
December 12, 2024
Reported by FDA
January 22, 2025
Distribution
Nationwide in the US

View recall →

Drug Recall Ongoing Historical recordClass III

Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8028-1.

by Akron Pharma, Inc.

Reason
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Recall initiated
December 12, 2024
Reported by FDA
January 22, 2025
Distribution
Nationwide in the US

View recall →

Drug Recall Ongoing Historical recordClass III

Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US RT 46 W Building E, Suite 117, Fairfield, NJ 07034, NDC 71399-8022-02

by Akron Pharma, Inc.

Reason
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Recall initiated
December 12, 2024
Reported by FDA
January 22, 2025
Distribution
Nationwide in the US

View recall →

Drug Recall Ongoing Historical recordClass III

Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01.

by Akron Pharma, Inc.

Reason
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Recall initiated
December 12, 2024
Reported by FDA
January 22, 2025
Distribution
Nationwide in the US

View recall →

Drug Recall Ongoing Historical recordClass III

Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8024-01 .

by Akron Pharma, Inc.

Reason
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Recall initiated
December 12, 2024
Reported by FDA
January 22, 2025
Distribution
Nationwide in the US

View recall →

Drug Recall Ongoing Historical recordClass III

Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8022-01.

by Akron Pharma, Inc.

Reason
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Recall initiated
December 12, 2024
Reported by FDA
January 22, 2025
Distribution
Nationwide in the US

View recall →

Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60

by Rising Pharma Holding, Inc.

Reason
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Recall initiated
December 30, 2024
Reported by FDA
January 15, 2025
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Grand Cayman Islands, NDC 82009-117-10

by Granules Pharmaceuticals Inc.

Reason
Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
Recall initiated
December 30, 2024
Reported by FDA
January 15, 2025
Distribution
Distributor in OH.

View recall →

Drug Recall Ongoing Historical recordClass II

Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured for: Jubilant Draximage Inc., dba Jubilant Radiopharma, Kirkland , Quebec, H9H, 4J$, Canada, NDC# 65174-179-05.

by Jubilant Draximage Inc., dba Jubilant Radiopharma

Reason
Failed Stability Specifications
Recall initiated
November 22, 2024
Reported by FDA
January 15, 2025
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ

by Rising Pharma Holding, Inc.

Reason
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Recall initiated
December 30, 2024
Reported by FDA
January 15, 2025
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ

by Rising Pharma Holding, Inc.

Reason
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Recall initiated
December 30, 2024
Reported by FDA
January 15, 2025
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03

by Granules Pharmaceuticals Inc.

Reason
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Recall initiated
December 18, 2024
Reported by FDA
January 15, 2025
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor NJ 08520 NDC # 55150-306-10

by Eugia US LLC

Reason
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Recall initiated
December 27, 2024
Reported by FDA
January 15, 2025
Distribution
Distributed Nationwide in the USA.

View recall →

Drug Recall Ongoing Historical recordClass II

medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for: Eugia US LLC, NJ 08520 NDC 55150-329-01 Shipper label: medroxyPROGESTERone Acetate Injectable Suspension, USP, 150 mg per mL, Distributed by: Eugia US LLC, NJ, Manufactured by: Eugia Pharma Specialties Limited, India

by Eugia US LLC

Reason
CGMP Deviations
Recall initiated
December 18, 2024
Reported by FDA
January 15, 2025
Distribution
Nationwide in the US

View recall →

Drug Recall Ongoing Historical recordClass II

Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-21

by Amerisource Health Services LLC

Reason
Presence of Foreign Tablets/Capsules
Recall initiated
December 13, 2024
Reported by FDA
January 15, 2025
Distribution
Nationwide within the United States

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.