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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 1,421–1,440 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

ABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distributed By: Absorbine Jr. LLC, Chattanooga, TN 37402 UPC 8 89476 41318 3, UPC 8 89476 41336 7

by Unexo Life Sciences Private Limited

Reason
cGMP Deviations
Recall initiated
October 24, 2024
Reported by FDA
December 4, 2024
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

ABSORBINE jr. Extra Large BACK PATCH, Menthol 5%, 1 extra large patch per box, Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402 UPC 8 89476 41218 6, UPC 8 89476 41236 0

by Unexo Life Sciences Private Limited

Reason
cGMP Deviations
Recall initiated
October 24, 2024
Reported by FDA
December 4, 2024
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by: Walmart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, NDC# 68645-610-90.

by Evaric Pharmaceuticals Inc.

Reason
Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.
Recall initiated
November 15, 2024
Reported by FDA
November 27, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01

by Safecor Health, LLC

Reason
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Recall initiated
November 11, 2024
Reported by FDA
November 27, 2024
Distribution
USA nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-106-01

by Safecor Health, LLC

Reason
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Recall initiated
November 11, 2024
Reported by FDA
November 27, 2024
Distribution
USA nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-129-01

by Safecor Health, LLC

Reason
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Recall initiated
November 11, 2024
Reported by FDA
November 27, 2024
Distribution
USA nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01

by Safecor Health, LLC

Reason
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Recall initiated
November 11, 2024
Reported by FDA
November 27, 2024
Distribution
USA nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01

by Safecor Health, LLC

Reason
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Recall initiated
November 11, 2024
Reported by FDA
November 27, 2024
Distribution
USA nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a foil-sealed polypropylene tray, packed in a paper carton/box, MANUFACTURED BY NOVEN PHARMACEUTICALS, INC., Miami, FL 33186 United Sates, NDC 68968-0215-3

by Noven Pharmaceuticals Inc

Reason
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Recall initiated
October 31, 2024
Reported by FDA
November 27, 2024
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Recall initiated
October 23, 2024
Reported by FDA
November 27, 2024
Distribution
Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Recall initiated
October 23, 2024
Reported by FDA
November 27, 2024
Distribution
Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 68180-589-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Recall initiated
October 23, 2024
Reported by FDA
November 27, 2024
Distribution
Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syringe, Rx Only, Repackaged by: Medivant Healthcare: 24416 N 19th Ave, Phoenix, AZ, NDC 81483-0041-1

by Tailstorm Health INC

Reason
Lack of Sterility Assurance
Recall initiated
November 6, 2024
Reported by FDA
November 27, 2024
Distribution
Nationwide Within U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason
Failed Impurity/Degradation Specifications
Recall initiated
November 7, 2024
Reported by FDA
November 27, 2024
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7135-72

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason
Failed Impurity/Degradation Specifications
Recall initiated
November 7, 2024
Reported by FDA
November 27, 2024
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass III

Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427. NDC: 45802-0063-05

by Padagis US LLC

Reason
Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
Recall initiated
October 11, 2024
Reported by FDA
November 27, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass III

IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Tablet/Capsule Specifications
Recall initiated
October 29, 2024
Reported by FDA
November 27, 2024
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.5 g) pumps, Mint flavor, Manufactured by: Keystone Industries, 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC 68400-202-10

by Keystone Industries

Reason
Subpotent Drug
Recall initiated
October 17, 2024
Reported by FDA
November 20, 2024
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass III

Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, Livonia, MI, 48152, USA, NDC 0904-6441-61.

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Recall initiated
November 5, 2024
Reported by FDA
November 20, 2024
Distribution
Nationwide in the US.

View recall →

Drug Recall Ongoing Historical recordClass II

Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan Pharmaceuticals, NDC 76282-0478-90

by Cipla USA, Inc.

Reason
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Recall initiated
October 23, 2024
Reported by FDA
November 20, 2024
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.