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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 1,941–1,960 of 17,937 drug recalls

Drug Recall Ongoing Historical recordClass II

Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, Packaged by: Legacy Pharmaceutical Packaging LLC., Earth City, MO 63045, NDC# 68645-523-54

by Legacy Pharmaceutical Packaging LLC

Reason
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Recall initiated
December 11, 2023
Reported by FDA
January 3, 2024
Distribution
CA and AR

View recall →

Drug Recall Terminated Historical recordClass II

Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution, 30mL Amber Glass Vial, Rx only, AnazaoHealth, 7465 W. Sunset Road, Las Vegas, NV, NDC 72682-8721-3.

by AnazaoHealth Corporation

Reason
Presence of Particulate Matter.
Recall initiated
November 22, 2023
Reported by FDA
January 3, 2024
Distribution
Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

B-Complex, Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxine HCI injection, 74/2/75/2/2 MG/ML, 30ML Sterile Multiple-Dose Vial, Rx only, AnazaoHealth, 7465 W Sunset Rd #1200, Las Vegas, NV 89113, NDC 72682-2230-3

by AnazaoHealth Corporation

Reason
Presence of Particulate Matter.
Recall initiated
November 22, 2023
Reported by FDA
January 3, 2024
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 500/50MCG, 60 Doses of Inhalation Powder, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-9320-32

by CARDINAL HEALTHCARE

Reason
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated
January 26, 2022
Reported by FDA
January 3, 2024
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Warfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1721-01

by CARDINAL HEALTHCARE

Reason
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated
January 26, 2022
Reported by FDA
January 3, 2024
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Warfarin Sodium Tablets, USP, 2.5 mg, 100 Tablets per bottle, Rx only, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1714-01

by CARDINAL HEALTHCARE

Reason
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated
January 26, 2022
Reported by FDA
January 3, 2024
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per bottle, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19136. NDC 0527-1632-01

by CARDINAL HEALTHCARE

Reason
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated
January 26, 2022
Reported by FDA
January 3, 2024
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Terconazole Vaginal Suppositories, 80 mg, 3 Suppositories with Vaginal Applicator, Rx only, Manufactured by: Cosette Pharmaceuticals, Inc., 111 Coolidge Street, South Plainfield, NJ 07080. NDC: 0713-0552-73

by CARDINAL HEALTHCARE

Reason
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated
January 26, 2022
Reported by FDA
January 3, 2024
Distribution
Nationwide USA

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Drug Recall Terminated Historical recordClass II

SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 capsules, 3 blister cards, each card contains 10 capsules, Rx only, For oral inhalation only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 0597-0075-41

by CARDINAL HEALTHCARE

Reason
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated
January 26, 2022
Reported by FDA
January 3, 2024
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box, Rx Only, Distributed by: Alvogen, Inc., Morristown, NJ 07960. NDC 47781-304-03

by CARDINAL HEALTHCARE

Reason
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated
January 26, 2022
Reported by FDA
January 3, 2024
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Ricola CherryHoney Herb Throat Drops (menthol, 1.8 mg), 10 Drops per roll, Manufacturer: Ricola Ltd., 4242 Laufen, Switzerland; Distributed by: Ricola USA Inc., 6 Campus Drive, 2nd Floor South, Parsippany, NJ 07054. NDC: 54305-507-10

by CARDINAL HEALTHCARE

Reason
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated
January 26, 2022
Reported by FDA
January 3, 2024
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 69238-2078-1

by CARDINAL HEALTHCARE

Reason
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated
January 26, 2022
Reported by FDA
January 3, 2024
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

PredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801. NDC: 59746-175-06

by CARDINAL HEALTHCARE

Reason
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated
January 26, 2022
Reported by FDA
January 3, 2024
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Nyamyc, 100,000 USP units per gram, 60 grams, Rx only, Topical Use Only, Manufactured by: Upsher-Smith Laboratories, Inc, Minneapolis, MN 55447.

by CARDINAL HEALTHCARE

Reason
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated
January 26, 2022
Reported by FDA
January 3, 2024
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 45963-676-96

by CARDINAL HEALTHCARE

Reason
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated
January 26, 2022
Reported by FDA
January 3, 2024
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Meloxicam Tablets, USP, 15 mg, 1000 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., Kurkumbh, India; Manufactured for: Cipla USA, Inc., 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156. NDC: 69097-159-15

by CARDINAL HEALTHCARE

Reason
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated
January 26, 2022
Reported by FDA
January 3, 2024
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-1300-01

by CARDINAL HEALTHCARE

Reason
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated
January 26, 2022
Reported by FDA
January 3, 2024
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Nagpur-441 108, India. NDC: 68180-518-01

by CARDINAL HEALTHCARE

Reason
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated
January 26, 2022
Reported by FDA
January 3, 2024
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, 1 Blister Pack Containing 28 Tablets, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1554-6

by CARDINAL HEALTHCARE

Reason
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated
January 26, 2022
Reported by FDA
January 3, 2024
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin, Ohio 43017. NDC: 70000-0126-1

by CARDINAL HEALTHCARE

Reason
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated
January 26, 2022
Reported by FDA
January 3, 2024
Distribution
Nationwide USA

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.