Browse Drug Recalls
57 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 57 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 57 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 9, 2026 | Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactu... | Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidiz... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Dec 30, 2025 | Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by... | Subpotent Drug: Due oxidation caused by leakage of the contents of the Icosapent Ethyl 1g capsule... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Dec 19, 2025 | traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufact... | Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on ... | Class III | Zydus Pharmaceuticals (USA) Inc |
| Oct 23, 2025 | Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. ... | Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- B... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Oct 22, 2025 | clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bot... | cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impuritie... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Oct 22, 2025 | clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bot... | cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impuritie... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Oct 22, 2025 | clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bot... | cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impuritie... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 24, 2025 | Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydu... | Failed impurity/degradation specifications:Out of Specification result for an individual organic ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 24, 2025 | Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zy... | Failed impurity/degradation specifications:Out of Specification result for an individual organic ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 4, 2025 | Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus L... | Failed Impurity/Degradation Specifications | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 4, 2025 | Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lif... | Failed Impurity/Degradation Specifications | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, ... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only,... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only,... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, ... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only,... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only,... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, ... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only,... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, ... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, ... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Aug 27, 2025 | Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 ... | Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| May 30, 2025 | Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactur... | Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsul... | Class II | Zydus Pharmaceuticals (USA) Inc |
| May 13, 2025 | Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count S... | Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| May 13, 2025 | Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count s... | Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Apr 3, 2025 | chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles... | CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended in... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Mar 21, 2025 | Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesci... | Presence of Foreign Substance: Product complaint received for the presence of foreign material em... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Feb 13, 2025 | Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose... | Failed Impurities/Degradation Specifications | Class II | Zydus Pharmaceuticals (USA) Inc |
| Feb 13, 2025 | Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose... | Failed Impurities/Degradation Specifications | Class II | Zydus Pharmaceuticals (USA) Inc |
| Nov 14, 2024 | Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-D... | Labeling: Not Elsewhere Classified - Wrong NDC number | Class III | Zydus Pharmaceuticals (USA) Inc |
| Jul 2, 2024 | Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufa... | Cross contamination with other products | Class III | Zydus Pharmaceuticals (USA) Inc |
| Jul 2, 2024 | Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufa... | Cross contamination with other products | Class III | Zydus Pharmaceuticals (USA) Inc |
| Jul 2, 2024 | Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Singl... | Cross contamination with other products. | Class III | Zydus Pharmaceuticals (USA) Inc |
| Jul 2, 2024 | Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a)... | Cross contamination with other products. | Class III | Zydus Pharmaceuticals (USA) Inc |
| Jun 27, 2024 | Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only,... | Presence of particulate matter: glass | Class II | Zydus Pharmaceuticals (USA) Inc |
| Jun 21, 2024 | Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in ... | Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| May 16, 2024 | Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manuf... | Failed Impurities/Degradation Specifications. | Class III | Zydus Pharmaceuticals (USA) Inc |
| May 16, 2024 | Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufa... | Failed Impurities/Degradation Specifications. | Class III | Zydus Pharmaceuticals (USA) Inc |
| Oct 19, 2023 | Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx... | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolutio... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Oct 19, 2023 | Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx... | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolutio... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Oct 19, 2023 | Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx ... | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolutio... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 21, 2023 | Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 6... | Failed Dissolution Specifications | Class II | Zydus Pharmaceuticals (USA) Inc |
| Feb 24, 2023 | Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-... | Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed d... | Class III | Zydus Pharmaceuticals (USA) Inc |
| Jul 15, 2022 | Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled ... | Failed Impurities/Degradation Specifications | Class II | Zydus Pharmaceuticals (USA) Inc |
| Aug 13, 2021 | Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by:... | Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle | Class II | Zydus Pharmaceuticals (USA) Inc |
| Feb 18, 2021 | Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For In... | Crystallization: customer complaints for crystallization in finished product. | Class I | Zydus Pharmaceuticals (USA) Inc |
| Feb 18, 2021 | Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For I... | Crystallization: customer complaints for crystallization in finished product. | Class I | Zydus Pharmaceuticals (USA) Inc |
| Dec 3, 2020 | Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablet... | Failed Dissolution Specifications | Class II | Zydus Pharmaceuticals (USA) Inc |
| Dec 3, 2020 | Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets... | Failed Dissolution Specifications | Class II | Zydus Pharmaceuticals (USA) Inc |
| Oct 27, 2020 | Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count c... | Failed Dissolution Specification | Class II | Zydus Pharmaceuticals (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.