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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.