Browse Drug Recalls
3,458 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,458 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 3,458 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 19, 2019 | Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%... | cGMP Deviations | Class II | Allergan Sales, LLC |
| Mar 14, 2019 | Losartan 50mg Tablet, 30 count each blister card. | CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmace... | Class II | RemedyRepack Inc. |
| Mar 12, 2019 | Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx D... | CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in th... | Class II | Direct Rx |
| Mar 8, 2019 | Losartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorpo... | CGMP deviation: Product found to contain trace amounts of NMBA | Class II | PD-Rx Pharmaceuticals, Inc. |
| Mar 7, 2019 | Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Ace... | CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA)... | Class II | Rising Pharmaceuticals, Inc. |
| Mar 7, 2019 | Valsartan Tablets 320 mg USP, 90 tablet bottles, Distributed by: Acetris Heal... | CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA)... | Class II | Rising Pharmaceuticals, Inc. |
| Mar 7, 2019 | Valsartan Tablets 80 mg USP, 90 tablet bottles, Rx only, Distributed by: Ace... | CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA)... | Class II | Rising Pharmaceuticals, Inc. |
| Mar 7, 2019 | Valsartan Tablets 160 mg USP, 90 tablet bottles, Rx only, Distributed by: Ace... | CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA)... | Class II | Rising Pharmaceuticals, Inc. |
| Mar 6, 2019 | Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, ... | CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the... | Class II | American Health Packaging |
| Mar 6, 2019 | Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-0... | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified. | Class II | Preferred Pharmaceuticals, Inc |
| Mar 5, 2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tab... | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified | Class II | AVKARE Inc. |
| Mar 5, 2019 | Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx On... | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified | Class II | AVKARE Inc. |
| Mar 5, 2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tabl... | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified | Class II | AVKARE Inc. |
| Mar 4, 2019 | Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 m... | CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found ... | Class II | H J Harkins Company Inc dba Pharma Pac |
| Mar 1, 2019 | Losartan Potassium Tablets, USP, 100 mg, 30 tablet bottles, Rx Only, Distrib... | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected | Class II | Legacy Pharmaceutical Packaging LLC |
| Mar 1, 2019 | Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distribut... | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected. | Class II | Legacy Pharmaceutical Packaging LLC |
| Mar 1, 2019 | Losartan Potassium Tablets, USP, 25 mg, 30 tablet bottles, Rx Only, Distribut... | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected | Class II | Legacy Pharmaceutical Packaging LLC |
| Mar 1, 2019 | Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distribut... | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected | Class II | Legacy Pharmaceutical Packaging LLC |
| Feb 28, 2019 | Losartan Potassium Tablets USP, 50 mg, Rx only, a) 30 count (NDC 31722-701-30... | CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the ... | Class II | Camber Pharmaceuticals Inc |
| Feb 28, 2019 | Losartan Potassium Tablets USP, 100 mg, Rx only, a) 30 count (NDC 31722-702-3... | CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the ... | Class II | Camber Pharmaceuticals Inc |
| Feb 28, 2019 | Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg, a) 30-co... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) i... | Class II | Torrent Pharma Inc. |
| Feb 28, 2019 | Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, a) 30-coun... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) i... | Class II | Torrent Pharma Inc. |
| Feb 28, 2019 | Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90... | CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the ... | Class II | Camber Pharmaceuticals Inc |
| Feb 28, 2019 | LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b) ... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) i... | Class II | Torrent Pharma Inc. |
| Feb 28, 2019 | LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count (NDC: 13668-409-30), b) 9... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) i... | Class II | Torrent Pharma Inc. |
| Feb 28, 2019 | LOSARTAN POTASSIUM TABLETS, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b) 1... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) i... | Class II | Torrent Pharma Inc. |
| Feb 28, 2019 | Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, a) 30-cou... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) i... | Class II | Torrent Pharma Inc. |
| Feb 21, 2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 coun... | CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the... | Class II | Macleods Pharma Usa Inc |
| 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. |
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.