Browse Drug Recalls
3,374 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,374 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 3,374 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Mar 25, 2020 | LOSARTAN POTASSIUM TABLETS, USP 100 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 |
| Mar 25, 2020 | LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturi... | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... | Class II | Teva Pharmaceuticals USA |
| Mar 24, 2020 | Edema Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA,... | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Class II | Herbal Doctor Remedies |
| Mar 24, 2020 | Detoxin-S, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Rem... | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Class II | Herbal Doctor Remedies |
| Mar 24, 2020 | Herpes-G, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Reme... | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Class II | Herbal Doctor Remedies |
| Mar 24, 2020 | Dermatoxin, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Re... | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Class II | Herbal Doctor Remedies |
| Mar 24, 2020 | Acne Cystic, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor ... | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Class II | Herbal Doctor Remedies |
| Mar 24, 2020 | Phlegm Off, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Re... | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Class II | Herbal Doctor Remedies |
| Mar 24, 2020 | Stomach Cleanser, 500mg Capsules, 90-count bottles, Distributed by Herbal Doc... | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Class II | Herbal Doctor Remedies |
| Mar 24, 2020 | Tution 130, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA... | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Class II | Herbal Doctor Remedies |
| Mar 24, 2020 | Pain Away, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Rem... | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Class II | Herbal Doctor Remedies |
| Mar 24, 2020 | Lump Shrinker, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor... | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Class II | Herbal Doctor Remedies |
| Mar 24, 2020 | Age Back, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor Rem... | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Class II | Herbal Doctor Remedies |
| Mar 24, 2020 | Thyro-Lo, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Reme... | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Class II | Herbal Doctor Remedies |
| Mar 24, 2020 | Fungo Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA... | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Class II | Herbal Doctor Remedies |
| Mar 24, 2020 | Skin Moist, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Re... | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Class II | Herbal Doctor Remedies |
| Mar 24, 2020 | Fungo Off, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Re... | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Class II | Herbal Doctor Remedies |
| Mar 24, 2020 | Acupuncture, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 US... | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Class II | Herbal Doctor Remedies |
| Mar 24, 2020 | Fire Off, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Reme... | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Class II | Herbal Doctor Remedies |
| Mar 24, 2020 | BioMycin, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Reme... | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Class II | Herbal Doctor Remedies |
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.