Browse Drug Recalls
50 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 50 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 50 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 26, 2025 | Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, ... | Presence of Foreign Tablets/Capsules | Class II | Golden State Medical Supply Inc. |
| Oct 20, 2025 | NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx onl... | Failed Dissolution Specifications | Class II | Golden State Medical Supply Inc. |
| Mar 5, 2025 | PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorp... | Failed Dissolution Specifications | Class II | Golden State Medical Supply Inc. |
| May 13, 2024 | Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottl... | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-dulox... | Class II | Golden State Medical Supply Inc. |
| Feb 14, 2024 | Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays,... | CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex | Class II | Golden State Medical Supply Inc. |
| Jan 12, 2024 | Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Markete... | Failed Dissolution Specifications | Class II | Golden State Medical Supply Inc. |
| Nov 10, 2023 | PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-... | Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out o... | Class II | Golden State Medical Supply Inc. |
| Nov 10, 2023 | PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-73... | Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out o... | Class II | Golden State Medical Supply Inc. |
| Nov 10, 2023 | PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-73... | Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out o... | Class II | Golden State Medical Supply Inc. |
| May 25, 2023 | Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx onl... | Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container. | Class II | Golden State Medical Supply Inc. |
| Oct 6, 2022 | Rifampin Capsules, USP, 300 mg, packaged in a) 30-count bottle (NDC 51407-323... | Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit fo... | Class II | Golden State Medical Supply Inc. |
| Oct 6, 2022 | Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Manufactured by Pat... | Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit fo... | Class II | Golden State Medical Supply Inc. |
| Sep 29, 2022 | Atenolol Tablets, USP, 25 mg, 1000-count bottle, Rx only, Manufactured by: AL... | Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets | Class I | Golden State Medical Supply Inc. |
| Mar 16, 2022 | Enalapril Maleate Tablets, USP; 20 mg; 90 tablets, NDC 60429-186-90; manufact... | CGMP Deviations | Class II | Golden State Medical Supply Inc. |
| Mar 16, 2022 | Enalapril Maleate Tablets, USP; 5 mg; 90 tablets, NDC 60429-184-90; manufactu... | CGMP Deviations | Class II | Golden State Medical Supply Inc. |
| Mar 16, 2022 | Enalapril Maleate Tablets, USP; 10 mg; 90 tablets, NDC 60429-185-90; manufact... | CGMP Deviations | Class II | Golden State Medical Supply Inc. |
| Mar 16, 2022 | Enalapril Maleate Tablets, USP; 2.5 mg; 90 tablets, NDC 60429-183-90; manufac... | CGMP Deviations | Class II | Golden State Medical Supply Inc. |
| Mar 2, 2022 | Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTR... | CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing ... | Class II | Golden State Medical Supply Inc. |
| Oct 14, 2021 | Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, M... | Failed Excipient Specification; product manufactured using an excipient found to be OOS for condu... | Class II | Golden State Medical Supply Inc. |
| Oct 14, 2021 | Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets,... | Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured us... | Class II | Golden State Medical Supply Inc. |
| Mar 19, 2021 | Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only,... | Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown i... | Class II | Golden State Medical Supply Inc. |
| Nov 17, 2020 | ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, M... | FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits f... | Class II | Golden State Medical Supply Inc. |
| Jul 24, 2020 | Clobetasol Propionate Cream, USP, 0.05%, packaged in a)15g Tubes (NDC 60429-9... | Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content ... | Class III | Golden State Medical Supply 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. |
| Feb 12, 2020 | TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg, Rx Only a)100-count bottles (NDC ... | Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets ... | Class III | Golden State Medical Supply Inc. |
| Nov 6, 2019 | GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-098-0... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Golden State Medical Supply Inc. |
| Nov 6, 2019 | GSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-0... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Golden State Medical Supply Inc. |
| Jun 14, 2019 | Losartan Potassium, 50 mg tablets, 90 count bottle, NDC 60429-317-90 | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... | Class II | Golden State Medical Supply Inc. |
| Jun 14, 2019 | Losartan Potassium, 100 mg tablets, 90 count bottle, NDC 60429-318-90 | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... | Class II | Golden State Medical Supply Inc. |
| Jun 14, 2019 | Losartan Potassium, 50 mg tablets, 30 count bottle, NDC 60429-317-30 | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... | Class II | Golden State Medical Supply Inc. |
| Jun 14, 2019 | Losartan Potassium, 50 mg tablets, 1000 count bottle, NDC 60429-317-10 | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... | Class II | Golden State Medical Supply Inc. |
| May 1, 2019 | Losartan Potassium Tablets USP 25 mg 90 count bottle NDC 60429-316-90 Rx only... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Golden State Medical Supply Inc. |
| May 1, 2019 | Losartan Potassium Tablets USP 100 mg 90 count bottle NDC 60429-318-90 Rx onl... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Golden State Medical Supply Inc. |
| May 1, 2019 | Losartan Potassium Tablets USP 100 mg 1000 count bottle NDC 60429-318-10 Rx o... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Golden State Medical Supply Inc. |
| May 1, 2019 | Losartan Potassium Tablets USP 25 mg 1000 count bottle NDC 60429-316-10 Rx on... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Golden State Medical Supply Inc. |
| May 1, 2019 | Losartan Potassium Tablets USP 25 mg 30 count bottle NDC 60429-316-30 Rx only... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Golden State Medical Supply Inc. |
| Nov 2, 2018 | IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciG... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine ... | Class II | Golden State Medical Supply Inc. |
| Nov 2, 2018 | IRBESARTAN Tablets, USP 150 mg (a) 30-count bottle (NDC 60429-641-30), (b) 90... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine ... | Class II | Golden State Medical Supply Inc. |
| Nov 2, 2018 | IRBESARTAN Tablets, USP 300 mg (a) 30-count bottle (NDC 60429-642-30), (b) 90... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine ... | Class II | Golden State Medical Supply Inc. |
| Aug 3, 2016 | Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, 90 capsules per ... | Failed Dissolution Specifications: Out-of-specification results in retained sample. | Class II | Golden State Medical Supply Inc. |
| Aug 3, 2016 | Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) 30 capsules p... | Failed Dissolution Specifications: Out-of-specification results in retained sample. | Class II | Golden State Medical Supply Inc. |
| Jun 28, 2016 | DULOXETINE Delayed-Release Capsules, USP, 60 mg, 1000 count bottles, Rx only,... | Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label ... | Class III | Golden State Medical Supply Inc. |
| Jan 27, 2016 | Atorvastatin Calcium 80 mg, 10 tablets per blister,100-count package, Rx Only... | Failed Impurities/Degradation Specifications | Class III | Golden State Medical Supply Inc. |
| Jan 27, 2016 | Atorvastatin Calcium 20 mg, 10 tablets per blister,100-count package, Rx Only... | Failed Impurities/Degradation Specifications | Class III | Golden State Medical Supply Inc. |
| Jan 27, 2016 | Atorvastatin Calcium 10 mg, 10 tablets per blister,100-count package, Rx Only... | Failed Impurities/Degradation Specifications | Class III | Golden State Medical Supply Inc. |
| Jan 27, 2016 | Atorvastatin Calcium 40 mg, 10 tablets per blister,100-count package, Rx Only... | Failed Impurities/Degradation Specifications | Class III | Golden State Medical Supply Inc. |
| Nov 25, 2015 | MECLIZINE HYDROCHLORIDE TABLETS, 12.5 mg, Packaged in 1000 ct Bottles, Rx Onl... | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Class III | Golden State Medical Supply Inc. |
| Nov 25, 2015 | MECLIZINE HYDROCHLORIDE TABLETS, 25 mg, Packaged in a) 100 ct Bottles (NDC: 6... | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Class III | Golden State Medical Supply Inc. |
| Aug 11, 2015 | METHOCARBAMOL TABLETS, USP 500 mg, 500 Count Bottles, Rx Only. Manufactured b... | Presence of Foreign Substance: Presence of hair. | Class III | Golden State Medical Supply Inc. |
| Apr 14, 2014 | LOSARTAN POTASSIUM Tablets, USP, 50 mg, 30 count bottles, Rx only, Manufactur... | Presence of Foreign Substance; some bottles may contain debris that was swept up during cleaning | Class II | Golden State Medical Supply 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.