Browse Drug Recalls

35 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 35 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 35 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Jul 20, 2022	Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured fo...	Labeling: Label Error on Declared Strength	Class III	AVKARE Inc.
Apr 13, 2022	Meclizine Hydrochloride Tablets, USP, 25 mg, 50-count cartons (5 x10 unit dos...	cGMP deviations: Temperature abuse	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Jun 9, 2021	Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured...	Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.	Class III	AVKARE Inc.
Dec 7, 2020	Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: A...	Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during b...	Class II	AVKARE Inc.
Dec 7, 2020	TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manuf...	Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during b...	Class I	AVKARE Inc.
Oct 30, 2020	Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bo...	Failed Dissolution Specifications	Class II	AVKARE Inc.
Jun 4, 2020	Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	AVKARE Inc.
Jun 4, 2020	Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (ND...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	AVKARE Inc.
May 28, 2020	Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-...	Presence of Foreign Substance consistent with granules from desiccant packs used during storage	Class III	AVKARE Inc.
May 26, 2020	Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured b...	Presence of Foreign Substance visually consistent with the silica granules present in the desicca...	Class III	Jubilant Cadista Pharmaceuticals, Inc.
Jan 7, 2020	Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx On...	Failed Impurities/Degradation Specifications: High out of specification results for related compo...	Class II	AVKARE Inc.
Nov 14, 2019	AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, I...	CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API	Class II	AVKARE Inc.
Nov 14, 2019	AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. ...	CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API	Class II	AVKARE Inc.
Oct 17, 2019	AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 4229...	CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API	Class II	AVKARE Inc.
Oct 17, 2019	AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 4229...	CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API	Class II	AVKARE Inc.
Aug 28, 2019	AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Table...	Failed Stability Specifications.	Class II	AVKARE Inc.
Apr 24, 2019	Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC ...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	AVKARE Inc.
Apr 24, 2019	Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC ...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	AVKARE Inc.
Apr 3, 2019	Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufact...	Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)	Class III	AVKARE Inc.
Mar 5, 2019	Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tabl...	CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified	Class II	AVKARE Inc.
Mar 5, 2019	Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx On...	CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified	Class II	AVKARE Inc.
Mar 5, 2019	Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tab...	CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified	Class II	AVKARE Inc.
Mar 1, 2019	Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 4...	Failed Dissolution Specifications	Class III	AVKARE Inc.
Nov 20, 2018	Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./...	Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product	Class II	AVKARE Inc.
Aug 14, 2018	Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-78...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	AVKARE Inc.
Aug 14, 2018	Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-78...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	AVKARE Inc.
Aug 14, 2018	Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-7...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	AVKARE Inc.
Aug 14, 2018	Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit ...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	AVKARE Inc.
Mar 30, 2018	Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only,...	Failed Dissolution Specifications	Class II	AVKARE Inc.
Jan 3, 2018	Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, M...	Failed Dissolution Specifications: Low out of specification results for dissolution during annual...	Class II	AVKARE Inc.
Oct 6, 2017	Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dos...	Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.	Class II	AVKARE Inc.
Jul 19, 2017	Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Ma...	Failed impurities/degradation specifications: Out of specification for a related compound C.	Class III	AVKARE Inc.
Feb 15, 2017	Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only,...	Failed impurities/ degradation specifications: Product was above specification for unknown impuri...	Class II	AVKARE Inc.
Feb 27, 2015	Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Man...	Subpotent Drug	Class III	AVKARE Inc.
Feb 27, 2015	Quinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Ma...	Subpotent Drug	Class III	AVKARE 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.