Browse Drug Recalls
91 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 91 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 91 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 21, 2019 | Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Hyoscyamine Oral Drops 0.125 mg/mL, Rx Only, 15 mL bottle (0.5 FL. oz.), NDC:... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Memantine Hydrochloride Oral Solution, 2 mg/mL, Rx Only, 12 FL. oz.. bottle, ... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Kid Kare Childrens Cough/Cold Liquid, Antihistamine, Cough Suppressant, Nasal... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Nasal Decongestant Liquid, Pseudoephedrine HCl, 30 mg in each teaspoonful, 4 ... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| Apr 30, 2019 | Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and ... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Preferred Pharmaceuticals, Inc |
| Apr 24, 2019 | Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distribut... | CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found ... | Class II | Legacy Pharmaceutical Packaging LLC |
| Apr 18, 2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Apr 18, 2019 | Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)10... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Apr 18, 2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-co... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Apr 18, 2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg, a) 30-c... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Apr 18, 2019 | Losartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b)10... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Apr 18, 2019 | Losartan Potassium Tablets, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b)1... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| 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 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 / 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 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 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, 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 / 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 / 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. |
| 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 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 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 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 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. |
| Sep 11, 2018 | Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx ... | Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at th... | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 m... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle, Rx... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 m... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by:... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 ... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, R... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Feb 25, 2016 | Telmisartan Tablets, USP, 80 mg, 30-count (3 x 10 unit-dose blisters) per car... | Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as... | Class III | Torrent Pharmaceuticals Limited |
| Jul 22, 2013 | Olanzapine Tablets, USP, 10 mg, Rx Only, 30 tablets per bottle, Mfd for: Pras... | Defective Container; This action is being taken as a precautionary measure due to the product bei... | Class II | Torrent Pharma 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.