Browse Drug Recalls
55 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 55 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 55 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 27, 2025 | Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: T... | CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. | Class II | Torrent Pharma Inc. |
| May 27, 2025 | Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured... | CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. | Class II | Torrent Pharma Inc. |
| Apr 11, 2022 | Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets ... | CGMP deviations: tablets cracking | Class II | Torrent Pharma Inc |
| Dec 2, 2021 | Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufa... | Failed Dissolution Specifications | Class II | Torrent Pharma Inc. |
| Dec 1, 2021 | Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bot... | Superpotent; Hydrochlorothiazide | Class III | Torrent Pharma Inc. |
| Mar 15, 2021 | Darifenacin Extended-release Tablets 7.5 mg 30 Tablets Rx only Manufactured b... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Darifenacin Extended-release Tablets 15 mg 30 Tablets Rx only, Manufactured ... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Nov 25, 2020 | Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India f... | Failed Dissolution Specifications | Class I | Torrent Pharma Inc |
| May 11, 2020 | Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, M... | Failed Dissolution Specifications | Class II | Torrent Pharma Inc. |
| Sep 19, 2019 | Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx O... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Sep 19, 2019 | Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manuf... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Sep 19, 2019 | Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets ... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Sep 19, 2019 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets p... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Sep 6, 2019 | Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in... | Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities de... | Class II | Torrent Pharma Inc. |
| May 21, 2019 | Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only, Rx only... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Lactulose Solution, USP 10 g/15 mL, For Oral Administration, Rx Only, a) 16 F... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 13668-589... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 ... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Lactulose Solution, USP 10 g/15 mL, For Oral or Rectal Administration, Rx Onl... | 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 |
| 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. |
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.