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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 5,221–5,240 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

BENZEFOAM EMOLLIENT FOAM BENZOYL PEROXIDE 5.3% 100GM TOP EMOL NDC 187-0194--10; OTC; FOAMS

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

Nuedexta (dextromethorphan HBr and quinidine sulfate) Capsules 20 mg/10 mg 60 capsules Rx only NDC 64597-301-60 Manufactured by Patheon, Inc. Whitby, ON L1N 5Z5, Canada

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

AMOXICILLIN 500MG 100; NDC/UPC 65862001401; RX; TABLETS

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) Inhalation Aerosol 9 mcg/4.8 mcg per inhalation For Oral Inhalation only 120 inhalations Rx Only NDC 0310-4600-12 Mfd for: AstraZeneca Pharmaceuticals, LP, Wilmington, DE 19850

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

GEMCITABINE INJECTION 200MG/5.26ML; NDC/UPC 72485-221-02; RX; SINGLEDOSE VIAL

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

Timolol Maleate Ophthalmic Solution, USP 0.5% 2.5 mL Sterile For Topical Application In The Eye Rx Only NDC 60505-1005-4 Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2. 5 mL bottles Rx Only NDC 60505-0813-1 Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

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Drug Recall Terminated Historical recordClass II

TRAVOPROST OPHTHALMIC SOLUTION, USP 0.004% 2.5ML ; NDC/UPC 60505-0593-4; RX; DROPS

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

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Drug Recall Terminated Historical recordClass II

BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM 4MG/1MG 30 POUCHES EACH CONTAINING 1 SUBLINGUAL FILM NDC/UPC 47781-0356-03; RX; FILM

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

Vraylar (cariprazine) capsules in all pack sizes, styles and strengths Rx only Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

Namzaric (memantine HCl extended release and donepezil HCl) capsules 14 mg/10 mg per capsule 30 capsules Rx Only NDC 0456-1214-30 Distributed by Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, LLC.

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

BROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17; RX; DROPS

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

COSOPT (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution) (Dorzolamide Hydrochloride 22.3 mg/mL Timolol Maleate 6.8 mg/mL) 10ML Ocumeter Plus Ophthalmic Dispenser Sterile Ophthlamic Solution Rx only NDC/UPC 174780-605-10 Distributed by: Akorn, Inc. Lake Forest, IL 60045

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

Synthroid (levothyroxine sodium tablets, USP) in all pack sizes, styles and concentrations Rx only Abbott Laboratories North Chicago, IL

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass I

NP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain (90 mg) 100-count bottles, Rx only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-331-01

by Acella Pharmaceuticals, LLC

Reason
Subpotent Drug
Recall initiated
April 29, 2021
Reported by FDA
June 2, 2021
Distribution
Nationwide within the United States including Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-count bottles (NDC 42192-327-01) and b) 7-count bottles (NDC 42192-327-07), Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005

by Acella Pharmaceuticals, LLC

Reason
Subpotent Drug
Recall initiated
April 29, 2021
Reported by FDA
June 2, 2021
Distribution
Nationwide within the United States including Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), 30 Patches (NDC 68968-5553-1) per box (NDC 68968-5553-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186.

by Noven Pharmaceuticals Inc

Reason
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
Recall initiated
May 20, 2021
Reported by FDA
June 2, 2021
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), 30 Patches (NDC 68968-5552-1) per box (NDC 68968-5552-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186.

by Noven Pharmaceuticals Inc

Reason
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
Recall initiated
May 20, 2021
Reported by FDA
June 2, 2021
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, Bachupally 500 090, India, NDC 55111-121-05.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities
Recall initiated
May 4, 2021
Reported by FDA
June 2, 2021
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Enalapril Maleate Tablets, USP 2.5 mg 100 tablets Rx only Distributed by: Cardinal Health, NDC 64679-923-02

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

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.