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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 5,301–5,320 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

TIROSINT(levothyroxine sodium) capsules 175MCG 3 blisters X10 capsules; NDC/UPC 71858-0055-4; RX; CAPSULES

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

LEUCOVORIN 15MG 24; NDC/UPC 54449810; 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

LITHIUM CARB 150MG 100; NDC/UPC 54252625; RX; CAPSULES

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

Calcium Acetate Capsules 667 mg 200 Capsules Rx only NDC 23155-531-02 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724

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

AcetaZOLAMIDE Tablets, USP 125 mg 100 Tablets Rx only NDC 23155-287-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724

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

bupropion Hydrochloride Tablets, USP 75 mg 100 Tablets Rx only NDC 23155-191-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724

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

FaBB Vitamin B6 (as Pyridoxine Hydrochloride) 25 mg Folic Acid 2.2 mg Vitamin B12 (as Cyanocobalamin) 1.0 mg Dietary Supplement 100 Tablets Distributed by: H2-Pharma, LLC 2010 Berry Chase Place Montgomery, AL 36117

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

Hydrocortisone Ointment USP 1% Maximum Strength Net Wt. 1 oz (28 g) NDC 0472-0345-56 Manufactured by: Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28902

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

Triumeq (abacavir, dolutegravir, and lamivudine) 600 mg/50 mg/300 mg Tablets 30 Tablets Rx Only NDC 49702-231-13 Manufactured for: Viiv Healthcare Research Triangle Park, NC 27709 by GlaxoSmithKline Research Triangle Park, NC 27709

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

EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30; NDC/UPC 68462-321-30; 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

Verapamil Hydrochloride Extended-Release Tablets USP 120 mg Rx Only NDC 68462-292-01 Manufactured by: Glenmark Generics Ltd Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Generics Inc., USA Mahwah, NJ 07430

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

Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder) 100 mcg/62.5 mcg/25 mcg; 1 ELLIPTA Inhaler containing 30 doses (60 blisters total) Rx Only NDC 0173-0887-10 GlaxoSmithKline Research Triangle Park, NC 27709

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

TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMEDIDINIUM AND VILANTEROL INHALATION POWDER) 100-62.5-25MCG 60; NDC/UPC 0173-0893-10; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL

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

Arnuity Ellipta (fluticasone furoate inhalation powder) 200 mcg 1 Ellipta Inhaler containing 1 Foil Strip of 30 Blisters Rx Only NDC 0173-0876-10 GlaxoSmithKline Research Triangle Park, NC 27709

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

ADVAIR HFA 45-21MCG 12GM; NDC/UPC 173071520; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL

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

FLOVENT DISKUS 100MCG 60; NDC/UPC 173060202; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL

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

cathflo activase (ALTEPLASE) 2 mg Rx Only NDC 50242-041-64 Genentech

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

Prenatal Tablets Gluten Free Multivitamin/ Multimineral Dietary Supplement for Pregnant and Lactating Women UD 100 Tablets (10x10) NDC 77333-715-10 GenDose Pharmaceuticals

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

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP 10-30-2MG/5ML 473ML; NDC/UPC 71930-026-43; RX; SYRUP

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

Narcan (naloxone HCl) Nasal Spray 4 mg Two Pack This box contains two (2) 4-mg doses of naloxone HCl in 0.1 mL of nasal spray. 0.1 mL intranasal spray per unit For use in the nose only Rx only NDC 69547-353-02 Distributed by Adapt Pharma, Inc. Radnor, PA 19087 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 →

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.