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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 5,241–5,260 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup Net: 1 Pint (473 mL) Bulk Container-Not for Household Use Rx Only NDC 60432-275-16 Distributed By: Wockhardt USA, LLC 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

CYANOCOBAL Injection 1000MCG/ML 25X1ML; NDC/UPC 69680-112-25; RX; MULTI DOSE 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

Corgard (nadolol tablets, USP) 40 mg 100 Tablets Rx only NDC 27505-101-01 Distributed by US WorldMeds, LLC, Louisville, KY 40241

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

HALOPERIDOL TABLETS 20mg, USP, 100-count bottle, Rx Only Distributed by: Usher-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC: 0832-1560-11

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

Briviact (brivaracetam) tablets 50 mg, 60-count bottle, Rx only Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-570-66

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

VIMPAT(lacosamide) Tablets ,100 mg, 60-count bottle; Rx Only, Manufactured for: UCB, Inc. Smyrna, GA 30080

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

INTEGRA 325/40/3mg 90-count bottle, NDC: 52747-710-60

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

Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules 1 A Day Nutritional Supplement NDC 52747-200-30 Marketed by US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036

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

Darifenacin Extended-release Tablets 15 mg 30 Tablets Rx only, Manufactured by: Torrent Pharmaceuticals, LTD Indrad-382 721, India Manufactured for: Torrent Pharma Inc. Basking Ridge, NJ 07920, NDC 13668-203-30

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

Darifenacin Extended-release Tablets 7.5 mg 30 Tablets Rx only Manufactured by: Torrent Pharmaceuticals LTD. Indrad-382 721, India Manufactured for: Torrent Pharma Inc. Basking Ridge, NJ 07920, NDC 13668-202-30

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

Sulindac Tablets, USP, 200mg 100-count bottles, Rx Only, Manufactured by: Epic Pharma, LLC, Laurelton, NY 11413, NDC 42806-011-01

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

Desvenlafaxine Extended-Release Tablets 25 mg 30 Tablets Rx Only NDC 0591-4060-30 Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA

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

Levalbuterol tartrate HFA Inhalation Aerosol 45 mcg/actuation 200 Metered Inhalations Net Contents: 15 g Rx Only NDC 0591-2927-54 Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA

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

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 mg/6.25 mg, 100-count bottles, Rx Only, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-3241-01 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

NEOMYCIN SULF TABLETS, USP, 500mg, 100-count bottle, Rx Only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC: 0093-1177-01

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

Children's Loratadine Oral Solution USP, 5 mg/5 mL (Antihistamine) Allergy Grape Flavor 4 FL OZ (120 mL) NDC 51672-2131-8 Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532

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

Colcrys (colchicine, USP) tablets 0.6 mg 30 tablets Rx only Distributed by: Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015,NDC 64764-119-07

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

Collagenase Santyl Ointment 250 units/g 30 grams Rx Only Marketed by Smith & Nephew, Inc., Fort Worth, TX 76107, NDC 50484-010-30

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

Cefazolin for Injection, USP 1 gram per vial Rx Only Single-use Vial Sterile Manufactured in Austria by Sandoz GmbH for Sandoz, Inc., Princeton, NJ 08540, NDC 0781-3451-70

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

medroxyprogesterone acetate injectable suspension, USP, 150MG/ML 1ML, Rx Only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-4538-02

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.