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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 1,241–1,260 of 17,937 drug recalls

Drug Recall Ongoing Historical recordClass II

Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01.

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Recall initiated
January 29, 2025
Reported by FDA
February 26, 2025
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing Historical recordClass II

Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01.

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Recall initiated
January 29, 2025
Reported by FDA
February 26, 2025
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing Historical recordClass II

Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-758-01.

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Recall initiated
January 29, 2025
Reported by FDA
February 26, 2025
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing Historical recordClass II

Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01.

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Recall initiated
January 29, 2025
Reported by FDA
February 26, 2025
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing Historical recordClass II

Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01.

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Recall initiated
January 29, 2025
Reported by FDA
February 26, 2025
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing Historical recordClass II

Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01.

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Recall initiated
January 29, 2025
Reported by FDA
February 26, 2025
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing Historical recordClass II

Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Recall initiated
January 29, 2025
Reported by FDA
February 26, 2025
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing Historical recordClass II

Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30.

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Recall initiated
January 29, 2025
Reported by FDA
February 26, 2025
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing Historical recordClass II

Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30.

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Recall initiated
January 29, 2025
Reported by FDA
February 26, 2025
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing Historical recordClass II

Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30.

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Recall initiated
January 29, 2025
Reported by FDA
February 26, 2025
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing Historical recordClass II

Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Recall initiated
January 29, 2025
Reported by FDA
February 26, 2025
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing Historical recordClass II

Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30.

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Recall initiated
January 29, 2025
Reported by FDA
February 26, 2025
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing Historical recordClass II

Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30.

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Recall initiated
January 29, 2025
Reported by FDA
February 26, 2025
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing Historical recordClass I

Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single unit), Dist. by: Provepharm, Inc., Collegeville, PA 19426

by Provepharm Inc.

Reason
Presence of Particulate Matter.
Recall initiated
January 21, 2025
Reported by FDA
February 26, 2025
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Ongoing Historical recordClass II

Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal Pharmaceuticals of NY, LLC, NY 11719, NDC 42291-778-90

by AvKARE

Reason
Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)
Recall initiated
February 4, 2025
Reported by FDA
February 26, 2025
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6009-61.

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Recall initiated
January 21, 2025
Reported by FDA
February 26, 2025
Distribution
Nationwide U.S. and Puerto rico

View recall →

Drug Recall Ongoing Historical recordClass II

Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-905 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6008-61.

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Recall initiated
January 21, 2025
Reported by FDA
February 26, 2025
Distribution
Nationwide U.S. and Puerto rico

View recall →

Drug Recall Ongoing Historical recordClass II

Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6007-61

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Recall initiated
January 21, 2025
Reported by FDA
February 26, 2025
Distribution
Nationwide U.S. and Puerto rico

View recall →

Drug Recall Completed Historical recordClass II

fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01

by Fagron Compounding Services

Reason
Lack of Assurance of Sterility
Recall initiated
January 31, 2025
Reported by FDA
February 26, 2025
Distribution
Distributed in PA

View recall →

Drug Recall Ongoing Historical recordClass II

Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15

by AvKARE

Reason
Out of Specification for Dissolution
Recall initiated
January 21, 2025
Reported by FDA
February 19, 2025
Distribution
Nationwide in the 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.