Public Health Trace

Get Alerts

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

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 →

Drug Recall Ongoing Historical recordClass II

Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98

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 →

Drug Recall Ongoing Historical recordClass II

Trinity Gold Nutrition, 60 Capsule, 30 day Supply, Distributed by Trinity Gold Nutrition 201 Tom Hall St. Ste. 2107, Fortmill, SC 29716, USA, Ph: 704-629-8203, www.trinitygold.com, Made in India, UPC 802992001009

by Trinity Gold Nutrition

Reason: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
Recall initiated: November 6, 2024
Reported by FDA: November 20, 2024
Distribution: Nationwide within the United States; additionally Canada, England, and Australia.

View recall →

Drug Recall Ongoing Historical recordClass II

Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 61919-0621-15 (15 count bottles), b) NDC 61919-0621-30 (30 count bottles, c) NDC 61919-0621-40 (40 count bottles), d) NDC 61919-0621-60 (60 count bottles), e) NDC 61919-0621-90 (90 count bottles), f) NDC: 61919-0621-100 and NDC: 61919-0621-71 (100 count bottles), g) NDC 61919-0621-72 (120 count bottles).

by Direct Rx

Reason: Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Recall initiated: August 9, 2024
Reported by FDA: November 13, 2024
Distribution: Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass I

Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive, Bennet, NE 68317

by Staska Pharmaceuticals, Inc.

Reason: Presence of Particulate Matter: Presence of glass particulates.
Recall initiated: September 30, 2024
Reported by FDA: November 13, 2024
Distribution: Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Pharmaceutical Solutions, LLC, Bloomington, IN 47403; Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC: 36000-364-01

by Baxter Healthcare Corporation

Reason: Labeling: Missing Label
Recall initiated: October 30, 2024
Reported by FDA: November 13, 2024
Distribution: Nationwide within the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02.

by VIONA PHARMACEUTICALS INC

Reason: Crystallization
Recall initiated: October 29, 2024
Reported by FDA: November 13, 2024
Distribution: USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01.

by Dr. Reddy's Laboratories, Inc.

Reason: Failed Impurities/Degradation Specification
Recall initiated: October 22, 2024
Reported by FDA: November 13, 2024
Distribution: Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01.

by Dr. Reddy's Laboratories, Inc.

Reason: Failed Impurities/Degradation Specification
Recall initiated: October 22, 2024
Reported by FDA: November 13, 2024
Distribution: Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.

by FDC Limited

Reason: Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Recall initiated: October 29, 2024
Reported by FDA: November 13, 2024
Distribution: Distributed to one Us Distributor in NJ.

View recall →

Drug Recall Ongoing Historical recordClass III

Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code# 850015736018

by Denison Pharmaceuticals, LLC

Reason: Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Recall initiated: September 25, 2024
Reported by FDA: November 13, 2024
Distribution: Product was distributed to two accounts that may have distributed the product further to the Retail Level.

View recall →

Data last updated: October 31, 2026 ET

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.