Browse Drug Recalls

930 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 930 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 930 FDA drug recalls in 2020.

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Date	Product	Reason	Class	Firm
Jun 9, 2020	Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule, 90 capsules per bottle,...	Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and b...	Class I	MasterPharm LLC
Jun 5, 2020	metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	PD-Rx Pharmaceuticals, Inc.
Jun 5, 2020	metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	PD-Rx Pharmaceuticals, Inc.
Jun 5, 2020	Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx onl...	Discoloration: Out of Specification (OOS) result for APHA Color Test.	Class III	Akorn, Inc.
Jun 5, 2020	Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	Marksans Pharma Limited
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	Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactu...	Failed Impurities/Degradation Specification: There is a slow leaching process from the product l...	Class III	SOMERSET THERAPEUTICS LLC
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.
Jun 4, 2020	Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufact...	Failed Impurities/Degradation Specification: There is a slow leaching process from the product l...	Class III	SOMERSET THERAPEUTICS LLC
Jun 4, 2020	Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufact...	Failed Impurities/Degradation Specification: There is a slow leaching process from the product l...	Class III	SOMERSET THERAPEUTICS LLC
Jun 3, 2020	Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc), 14.4 FL OZ. (4...	cGMP Deviations: Soft Whisper Dandruff Shampoo was produced with water that failed USP specificat...	Class II	A.P. Deauville, LLC
Jun 3, 2020	Walker Hand Sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70%, 32 oz a...	Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a...	Class II	WALKER EMULSIONS INC
Jun 3, 2020	Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradim...	Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim.	Class II	Yusef Manufacturing Laboratories, LLC
Jun 3, 2020	Walker Emulsions Hand Sanitizer (60%), Non-Sterile Solution, Alcohol Antisept...	Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a...	Class II	WALKER EMULSIONS INC
Jun 2, 2020	Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 620...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	Teva Pharmaceuticals USA
Jun 2, 2020	Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC ...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	Teva Pharmaceuticals USA
Jun 1, 2020	Handese Advanced Instant Hand Sanitizer (Ethyl Alcohol 70%), 12 FL OZ (354 mL...	Subpotent Drug: Product was found to be subpotent. Product also has high pH levels	Class II	WORLD EVENT PROMOTIONS, LLC
May 29, 2020	amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only,...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	Amneal Pharmaceuticals of New York, LLC
May 29, 2020	Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only...	Presence of Particulate Matter: particulate matter identified after reconstitution.	Class II	Pfizer Inc.
May 29, 2020	amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	Amneal Pharmaceuticals of New York, LLC
May 29, 2020	amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only,...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	Amneal Pharmaceuticals of New York, LLC
May 29, 2020	amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 coun...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	Amneal Pharmaceuticals of New York, LLC
May 29, 2020	amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 9...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	Amneal Pharmaceuticals of New York, LLC
May 29, 2020	amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 ta...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	Amneal Pharmaceuticals of New York, LLC
May 29, 2020	amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 ta...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	Amneal Pharmaceuticals of New York, LLC
May 29, 2020	amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distribut...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	Amneal Pharmaceuticals of New York, LLC
May 29, 2020	amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, ...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	Amneal Pharmaceuticals of New York, LLC
May 29, 2020	amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tabl...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	Amneal Pharmaceuticals of New York, LLC
May 29, 2020	amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only ...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	Amneal Pharmaceuticals of New York, LLC
May 29, 2020	amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	Amneal Pharmaceuticals of New York, LLC
May 28, 2020	Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distrib...	Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle la...	Class II	Glaxosmithkline Consumer Healthcare Holdings
May 28, 2020	Gaviscon Liquid Antacid Extra Strength, Cool Mint, 12 FL OZ (355 mL) single p...	Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle la...	Class II	Glaxosmithkline Consumer Healthcare Holdings
May 28, 2020	Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: ...	Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.	Class II	Lupin Pharmaceuticals Inc.
May 28, 2020	oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Inject...	Subpotent drug - Product did not contain drug.	Class II	QuVa Pharma, Inc.
May 28, 2020	Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ. (355 ...	Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle la...	Class II	Glaxosmithkline Consumer Healthcare Holdings
May 28, 2020	Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distri...	Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle la...	Class II	Glaxosmithkline Consumer Healthcare Holdings
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 27, 2020	Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottl...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable in...	Class II	Apotex Inc.
May 27, 2020	Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 ...	Failed Dissolution Specifications	Class III	Pfizer 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.
May 26, 2020	Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: P...	Failed Impurities/ Degradation Specifications	Class III	Aurobindo Pharma USA Inc.
May 26, 2020	Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manuf...	Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low lev...	Class III	UNICHEM PHARMACEUTICALS USA INC
May 26, 2020	Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: P...	Failed Impurities/ Degradation Specifications	Class III	Aurobindo Pharma USA Inc.
May 22, 2020	NP Thyroid 90, Thyroid Tablets, USP, 1 & 1/2 grain (90 mg), 100-count bottles...	Superpotent Drug.	Class I	Acella Pharmaceuticals, LLC
May 22, 2020	Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose carto...	Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf l...	Class II	The Harvard Drug Group
May 22, 2020	NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottles, Rx...	Superpotent Drug.	Class I	Acella Pharmaceuticals, LLC
May 22, 2020	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat...	Some bottles may contain mixed strengths of the product.	Class II	Teva Pharmaceuticals USA
May 22, 2020	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat...	Some bottles may contain mixed strengths of the product.	Class II	Teva Pharmaceuticals USA
May 22, 2020	NP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg), 100-count bottles, Rx O...	Superpotent Drug.	Class I	Acella Pharmaceuticals, LLC
May 22, 2020	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat...	Some bottles may contain mixed strengths of the product.	Class II	Teva Pharmaceuticals USA

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.