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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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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

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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

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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

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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.

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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

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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

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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

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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

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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

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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

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Drug Recall Ongoing Historical recordClass I

Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-103-01

by ENDO USA, Inc.

Reason: Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Recall initiated: December 20, 2024
Reported by FDA: February 12, 2025
Distribution: USA nationwide.

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Drug Recall Terminated Historical recordClass III

Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-0775-16

by PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Reason: Superpotent; sodium benzoate preservative
Recall initiated: January 7, 2025
Reported by FDA: February 12, 2025
Distribution: OH

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Drug Recall Ongoing Historical recordClass II

Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. Made in India. Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152. NDC: 0904-7216-61

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

Reason: Failed Dissolution Specifications.
Recall initiated: January 30, 2025
Reported by FDA: February 12, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-328-10

by SKY PACKAGING

Reason: Failed Impurities/Degradation Specifications
Recall initiated: January 24, 2025
Reported by FDA: February 12, 2025
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-327-10

by SKY PACKAGING

Reason: Failed Impurities/Degradation Specifications
Recall initiated: January 24, 2025
Reported by FDA: February 12, 2025
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes in 1 CARTON, NDC 63459-910-15, Blister NDC 63459-910-12; (c) 1 syringe in 1 CARTON, NDC 63459-910-17 without safety guard and blister, Rx Only, Manufactured by: UAB Teva Baltics, Vilnius, Lithuania. Distributed by Teva Pharmaceuticals USA, Inc. North Wales PA 19454. Product of Israel.

by Teva Pharmaceuticals USA, Inc

Reason: Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Recall initiated: January 10, 2025
Reported by FDA: February 12, 2025
Distribution: Product was distributed nationwide.

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Drug Recall Terminated Historical recordClass II

Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00.

by RemedyRePack Inc.

Reason: CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Recall initiated: January 24, 2025
Reported by FDA: February 12, 2025
Distribution: FL

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Drug Recall Ongoing Historical recordClass II

Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark Pharmaceuticals, NJ.

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Recall initiated: January 22, 2025
Reported by FDA: February 12, 2025
Distribution: Nationwide in the U.S

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Drug Recall Ongoing Historical recordClass II

Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ.

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Recall initiated: January 22, 2025
Reported by FDA: February 12, 2025
Distribution: Nationwide in the U.S

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Drug Recall Ongoing Historical recordClass II

Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.

by FDC Limited

Reason: Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Recall initiated: January 23, 2025
Reported by FDA: February 12, 2025
Distribution: Distributed to one (1) Us Distributor in NJ

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Data last updated: October 31, 2026 ET

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.