Browse Drug Recalls
3,430 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,430 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 3,430 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 19, 2019 | Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-31... | CGMP Deviations: Finished product made with lovastatin drug substance that was out of specificati... | Class III | American Health Packaging |
| Feb 13, 2019 | Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and ... | CGMP Deviations: Finished product made with lovastatin drug substance that was out of specificati... | Class III | Lupin Pharmaceuticals Inc. |
| Feb 4, 2019 | 0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hos... | CGMP Deviations | Class II | ICU Medical Inc |
| Jan 18, 2019 | Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactu... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Prinston Pharmaceutical Inc |
| Jan 18, 2019 | Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huah... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Prinston Pharmaceutical Inc |
| Jan 18, 2019 | Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactu... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Prinston Pharmaceutical Inc |
| Jan 18, 2019 | Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Onl... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Prinston Pharmaceutical Inc |
| Jan 18, 2019 | Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg Rx Only 90 count ... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Prinston Pharmaceutical Inc |
| Jan 10, 2019 | Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | MAJOR PHARMACEUTICALS |
| Jan 9, 2019 | Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lu... | CGMP Deviations; presence of extraneous material in the was observed in area that is between the... | Class II | Lupin Pharmaceuticals Inc. |
| Jan 7, 2019 | Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, ... | CGMP Deviation; manufacturing batch record could not be located | Class II | Lupin Pharmaceuticals Inc. |
| Jan 2, 2019 | Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-7... | CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to ... | Class II | Lupin Pharmaceuticals Inc. |
| Jan 2, 2019 | Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-7... | CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to ... | Class II | Lupin Pharmaceuticals Inc. |
| Dec 31, 2018 | Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Au... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Aurobindo Pharma USA Inc. |
| Dec 31, 2018 | Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only,... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Aurobindo Pharma USA Inc. |
| Dec 31, 2018 | Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, ... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Aurobindo Pharma USA Inc. |
| Dec 31, 2018 | Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle,... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Aurobindo Pharma USA Inc. |
| Dec 31, 2018 | Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, ... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Aurobindo Pharma USA Inc. |
| Dec 31, 2018 | Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles,... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Aurobindo Pharma USA Inc. |
| Dec 31, 2018 | Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle,... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Aurobindo Pharma USA Inc. |
| Dec 31, 2018 | Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, ... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Aurobindo Pharma USA Inc. |
| Dec 31, 2018 | Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle,... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Aurobindo Pharma USA Inc. |
| Dec 31, 2018 | Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only,... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Aurobindo Pharma USA Inc. |
| Dec 20, 2018 | LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), ... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Torrent Pharma Inc. |
| Dec 20, 2018 | LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) ... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Torrent Pharma Inc. |
| Dec 20, 2018 | LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) ... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Torrent Pharma Inc. |
| Dec 20, 2018 | LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Torrent Pharma Inc. |
| Dec 20, 2018 | LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Torrent Pharma Inc. |
| Dec 19, 2018 | Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, ... | CGMP Deviations | Class II | Roberts Home Medical LLC |
| Dec 18, 2018 | CIDOFOVIR DIHYDRATE, (Non-Sterile, For Manufacturing Use), 10g, Rx only, ALP ... | CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. | Class II | LGM Pharma LLC |
| Nov 27, 2018 | Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Teva Pharmaceuticals USA |
| Nov 27, 2018 | Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Teva Pharmaceuticals USA |
| Nov 27, 2018 | Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Teva Pharmaceuticals USA |
| Nov 27, 2018 | Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Teva Pharmaceuticals USA |
| Nov 27, 2018 | Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Teva Pharmaceuticals USA |
| Nov 27, 2018 | Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, ... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Teva Pharmaceuticals USA |
| Nov 27, 2018 | Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Teva Pharmaceuticals USA |
| Nov 27, 2018 | Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, ... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Teva Pharmaceuticals USA |
| Nov 20, 2018 | Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only,... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... | Class II | Mylan Pharmaceuticals Inc. |
| Nov 20, 2018 | Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... | Class II | Mylan Pharmaceuticals Inc. |
| Nov 20, 2018 | Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only,... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... | Class II | Mylan Pharmaceuticals Inc. |
| Nov 20, 2018 | Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manu... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... | Class II | Mylan Pharmaceuticals Inc. |
| Nov 20, 2018 | Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manuf... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... | Class II | Mylan Pharmaceuticals Inc. |
| Nov 20, 2018 | Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manu... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... | Class II | Mylan Pharmaceuticals Inc. |
| Nov 20, 2018 | Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count b... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... | Class II | Mylan Pharmaceuticals Inc. |
| Nov 20, 2018 | Valsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manu... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... | Class II | Mylan Pharmaceuticals Inc. |
| Nov 16, 2018 | SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per fil... | cGMP violations noted during the firm's most recent inspection. | Class II | CAO Group, Inc. |
| Nov 16, 2018 | fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3c... | cGMP violations noted during the firm's most recent inspection. | Class II | CAO Group, Inc. |
| Nov 16, 2018 | FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, ... | cGMP violations noted during the firm's most recent inspection. | Class II | CAO Group, Inc. |
| Nov 16, 2018 | BeeGentle Honey Flavored Topical Anesthetic, Active ingredient Benzocaine 20%... | cGMP violations noted during the firm's most recent inspection. | Class II | CAO Group, 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.