Browse Drug Recalls

31 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 31 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 31 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Oct 6, 2025	Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-58...	CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake...	Class II	Heritage Pharmaceuticals Inc
Oct 6, 2025	Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-5...	CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake...	Class II	Heritage Pharmaceuticals Inc
Oct 6, 2025	Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-58...	CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake...	Class II	Heritage Pharmaceuticals Inc
Oct 6, 2025	Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-...	CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake...	Class II	Heritage Pharmaceuticals Inc
Oct 6, 2025	Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-58...	CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake...	Class II	Heritage Pharmaceuticals Inc
Oct 6, 2025	Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-57...	CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake...	Class II	Heritage Pharmaceuticals Inc
Nov 23, 2022	Desmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed b...	Subpotent Drug	Class II	Heritage Pharmaceuticals Inc
Apr 21, 2021	Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Ph...	Labeling: Incorrect or Missing Lot and/or Exp Date	Class III	Heritage Pharmaceuticals Inc
Mar 15, 2021	bupropion Hydrochloride Tablets, USP 75 mg 100 Tablets Rx only NDC 23155-191-...	CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Class II	Cardinal Health Inc.
Mar 15, 2021	Calcium Acetate Capsules 667 mg 200 Capsules Rx only NDC 23155-531-02 Manufac...	CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Class II	Cardinal Health Inc.
Mar 15, 2021	AcetaZOLAMIDE Tablets, USP 125 mg 100 Tablets Rx only NDC 23155-287-01 Manufa...	CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Class II	Cardinal Health Inc.
Oct 23, 2020	Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Dis...	Failed impurities/ degradation specifications: Out of specification impurity results were observe...	Class III	Heritage Pharmaceuticals Inc
Sep 24, 2020	Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Man...	Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.	Class III	Legacy Pharmaceutical Packaging LLC
Mar 23, 2020	Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactu...	Failed Dissolution Specifications: Out of specification result during long term testing in Tetrac...	Class I	Avet Pharmaceuticals, Inc.
Mar 23, 2020	Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactu...	Failed Dissolution Specifications: Out of specification result during long term testing in Tetrac...	Class I	Avet Pharmaceuticals, Inc.
May 21, 2019	PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx On...	Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL ...	Class I	Heritage Pharmaceuticals, Inc.
May 21, 2019	Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL, For Oral Use Only, Rx On...	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Torrent Pharma Inc
May 21, 2019	RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 23155-317...	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Torrent Pharma Inc
May 21, 2019	AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only,...	Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL ...	Class I	Heritage Pharmaceuticals, Inc.
May 3, 2019	Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only Manuf...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	Heritage Pharmaceuticals, Inc.
May 3, 2019	Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Ma...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	Heritage Pharmaceuticals, Inc.
May 3, 2019	Losartan Potassium Tablets USP 25 mg 90 film coated tablets Rx Only Manufa...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	Heritage Pharmaceuticals, Inc.
May 3, 2019	Losartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured b...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	Heritage Pharmaceuticals, Inc.
May 3, 2019	Losartan Potassium Tablets USP 100 mg 90 film coated tablets Manufactured b...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	Heritage Pharmaceuticals, Inc.
Feb 15, 2019	Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only,...	Subpotent Drug.	Class II	Heritage Pharmaceuticals, Inc.
Jan 2, 2019	Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, ...	Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle	Class II	Heritage Pharmaceuticals, Inc.
Oct 15, 2018	Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only,...	Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle	Class II	Heritage Pharmaceuticals, Inc.
Dec 17, 2015	Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 f...	Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result de...	Class III	Bio-pharm, Inc.
Mar 25, 2015	GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bot...	Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.	Class II	Heritage Pharmaceuticals, Inc.
Feb 25, 2015	RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcu...	Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with qu...	Class II	Heritage Pharmaceuticals, Inc.
Feb 25, 2015	Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by:...	Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with qu...	Class II	Heritage Pharmaceuticals, Inc.

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.