Browse Drug Recalls
45 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 45 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 45 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 19, 2025 | Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-51... | Failed Dissolution Specifications | Class II | Ascend Laboratories, LLC |
| Sep 19, 2025 | Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 6787... | Failed Dissolution Specifications | Class II | Ascend Laboratories, LLC |
| Sep 19, 2025 | Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-... | Failed Dissolution Specifications | Class II | Ascend Laboratories, LLC |
| Sep 19, 2025 | Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-... | Failed Dissolution Specifications | Class II | Ascend Laboratories, LLC |
| Aug 28, 2025 | Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by:... | Superpotent drug | Class II | Ascend Laboratories, LLC |
| Jul 21, 2025 | Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx... | Failed Dissolution Specifications: low dissolution results | Class II | Ascend Laboratories, LLC |
| Jul 9, 2025 | Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only,... | CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended ... | Class II | Ascend Laboratories, LLC |
| Jul 9, 2025 | Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only... | CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended ... | Class II | Ascend Laboratories, LLC |
| May 23, 2025 | Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx... | Failed Impurities/Degradation Specifications An out-of-specification result was observed in the r... | Class II | Ascend Laboratories, LLC |
| May 23, 2025 | Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx... | Failed Impurities/Degradation Specifications An out-of-specification result was observed in the r... | Class II | Ascend Laboratories, LLC |
| Dec 12, 2024 | Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured... | CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit | Class II | Ascend Laboratories, LLC |
| Dec 12, 2024 | Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured... | CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit | Class II | Ascend Laboratories, LLC |
| Sep 3, 2024 | Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets p... | Failed Dissolution Specifications | Class II | Ascend Laboratories, LLC |
| Jan 16, 2024 | Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of... | Failed Impurities/Degradation Specification: Out of specification for organic impurities | Class II | Ascend Laboratories, LLC |
| Dec 29, 2023 | Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle... | Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an ... | Class II | Ascend Laboratories, LLC |
| Jul 18, 2023 | Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, ... | Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organ... | Class III | Ascend Laboratories, LLC |
| Jul 11, 2023 | Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem... | Failed Dissolution Specifications | Class II | Ascend Laboratories, LLC |
| Mar 17, 2023 | Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manuf... | Out of specification (OOS) for Spectroscopic Identification test by IR. | Class II | Ascend Laboratories, LLC |
| Mar 14, 2023 | Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufa... | CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Da... | Class II | Ascend Laboratories, LLC |
| Mar 14, 2023 | Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle,... | CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Da... | Class II | Ascend Laboratories, LLC |
| Jan 5, 2023 | Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablet... | Failed Dissolution Specification | Class II | Ascend Laboratories, LLC |
| Jan 5, 2023 | Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablet... | Failed Dissolution Specification | Class II | Ascend Laboratories, LLC |
| Jan 5, 2023 | Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablet... | Failed Dissolution Specification | Class II | Ascend Laboratories, LLC |
| Dec 28, 2022 | Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 678... | Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on th... | Class II | Ascend Laboratories, LLC |
| Jan 12, 2022 | Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Table... | Failed Dissolution Specifications. | Class II | Ascend Laboratories, LLC |
| Dec 21, 2021 | Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem ... | Failed impurities/degradation specifications | Class II | Ascend Laboratories, LLC |
| Apr 12, 2021 | Cephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Susp... | Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detec... | Class II | Preferred Pharmaceuticals, Inc. |
| Jan 22, 2021 | Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx On... | CGMP Deviations: Individual Unidentified impurities results of the product was found at higher si... | Class II | Ascend Laboratories LLC |
| Jan 22, 2021 | Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx O... | CGMP Deviations: Individual Unidentified impurities results of the product was found at higher si... | Class II | Ascend Laboratories LLC |
| Dec 17, 2020 | Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL ... | Failed Impurity/Degradation Specifications | Class II | Ascend Laboratories LLC |
| Dec 17, 2020 | Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL ... | Failed Impurity/Degradation Specifications | Class II | Ascend Laboratories LLC |
| Nov 24, 2020 | Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by... | Failed Dissolution Specifications; Out of Specification (low) results were obtained. | Class II | Ascend Laboratories LLC |
| Jan 24, 2020 | Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactu... | cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API sour... | Class II | Ascend Laboratories LLC |
| Jan 22, 2020 | Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bo... | Failed Dissolution Specifications: low out of specification results for dissolution testing. | Class III | Ascend Laboratories LLC |
| Jul 19, 2019 | Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b)... | Failed Dissolution Specifications | Class II | Ascend Laboratories LLC |
| Jul 16, 2019 | Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07)... | CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... | Class II | Deva Holding AS - Cerkezkoy Subesi |
| Jul 16, 2019 | Temozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-0... | CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... | Class II | Deva Holding AS - Cerkezkoy Subesi |
| Jul 16, 2019 | Temozolomide Capsules, 250 mg, 5-count bottle, Rx only, Manufactured by: Deva... | CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... | Class II | Deva Holding AS - Cerkezkoy Subesi |
| Jul 16, 2019 | Temozolomide Capsules, 20 mg, packaged in a) 5-count bottle (NDC 67877-538-07... | CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... | Class II | Deva Holding AS - Cerkezkoy Subesi |
| Jul 16, 2019 | Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-0... | CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... | Class II | Deva Holding AS - Cerkezkoy Subesi |
| Jul 16, 2019 | Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-0... | CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... | Class II | Deva Holding AS - Cerkezkoy Subesi |
| Feb 22, 2019 | Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, M... | Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed du... | Class II | Ascend Laboratories LLC |
| Nov 14, 2018 | Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by:... | Presence of Foreign Substance; metal shard found in tablet | Class II | Ascend Laboratories LLC |
| May 5, 2017 | AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactu... | PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled w... | Class III | Ascend Laboratories LLC |
| Nov 2, 2016 | Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactu... | Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of... | Class II | Ascend Laboratories LLC |
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.