Browse Drug Recalls

3,394 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,394 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 3,394 FDA drug recalls.

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DateProductReasonClassFirm
Jul 11, 2020 ASSURED Instant Hand Sanitizer Aloe & Moisturizers, (70% ethyl alcohol), Pack... CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... Class II 4e Brands North America, Llc
Jul 11, 2020 blumen ADVANCED HAND SANITIZER, 70% ALCOHOL CONTENT, (70% ethyl alcohol), pac... CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... Class II 4e Brands North America, Llc
Jul 11, 2020 blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT (70% ethyl alcohol v/... CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... Class II 4e Brands North America, Llc
Jul 11, 2020 blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost ... CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... Class II 4e Brands North America, Llc
Jul 10, 2020 Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Man... cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufac... Class II Keryx Biopharmaceuticals, Inc.
Jul 9, 2020 Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottl... CGMP Deviations: Products manufactured at the same site were FDA testing found below the label cl... Class II Maquiladora Miniara Sa De Cv
Jul 7, 2020 Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottle... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Lupin Pharmaceuticals Inc.
Jul 7, 2020 Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottle... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Lupin Pharmaceuticals Inc.
Jul 7, 2020 Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Lupin Pharmaceuticals Inc.
Jul 7, 2020 Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottle... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Lupin Pharmaceuticals Inc.
Jul 3, 2020 Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bott... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Granules Pharmaceuticals Inc
Jul 2, 2020 bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL... CGMP Deviations Class II AAA Cosmetica, SA de CV
Jul 1, 2020 Lidothol Patch, Lidocaine 4.5% & Menthol 5%, In each patch: lidocaine 4.5% to... CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test ... Class II Preferred Pharmaceuticals, Inc.
Jun 25, 2020 Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distr... CGMP Deviations: Product was found to be below the label claim for ethanol content and the presen... Class II POLARIZED LLC
Jun 23, 2020 Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bott... cGMP deviations: one lot of the product was distributed to US Markets despite being rejected duri... Class III Biogen MA Inc.
Jun 17, 2020 Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage X... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acce... Class II Preferred Pharmaceuticals, Inc.
Jun 12, 2020 Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (1... CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established... Class II The Harvard Drug Group
Jun 11, 2020 Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Lupin Pharmaceuticals 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 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 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 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 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 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 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 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
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 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, 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, 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, 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 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, 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,... 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 Rx Only,... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Amneal Pharmaceuticals of New York, LLC
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 19, 2020 LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch, 15 Patches pe... CGMP Deviations: due to the loss of product manufacturing records and retain product samples, the... Class II Wuhan Bingbing Pharmaceutical Co., Ltd.
May 19, 2020 Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured ... CGMP Deviations: due to the loss of product manufacturing records and retain product samples, the... Class II Wuhan Bingbing Pharmaceutical Co., Ltd.
May 19, 2020 Maximum Strength Lidocaine Cold & Hot Patch (lidocaine 4%, menthol 1%), 5 pat... CGMP Deviations: due to the loss of product manufacturing records and retain product samples, the... Class II Wuhan Bingbing Pharmaceutical Co., Ltd.
May 19, 2020 LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch, packaged in ... CGMP Deviations: due to the loss of product manufacturing records and retain product samples, the... Class II Wuhan Bingbing Pharmaceutical Co., Ltd.
Apr 15, 2020 Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Di... CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the ... Class II Amneal Pharmaceuticals of New York, LLC
Apr 15, 2020 Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-coun... cGMP Deviations Class II H J Harkins Company Inc dba Pharma Pac
Apr 14, 2020 Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC... cGMP deviations: Presence of foreign material (Teflon)introduced at the production level. Class II B & B Pharmaceuticals, Inc.
Apr 3, 2020 Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30)... CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active i... Class II Golden State Medical Supply Inc.
Mar 26, 2020 Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II Avet Pharmaceuticals, Inc.
Mar 26, 2020 Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 c... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II Avet Pharmaceuticals, Inc.
Mar 25, 2020 LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufactur... CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... 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.