Browse Drug Recalls
32 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 32 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 32 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 24, 2025 | Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Onl... | CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit | Class II | Breckenridge Pharmaceutical, Inc. |
| Nov 24, 2025 | Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Onl... | CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit | Class II | Breckenridge Pharmaceutical, Inc. |
| Oct 9, 2025 | Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51... | CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm. | Class II | Breckenridge Pharmaceutical, Inc. |
| Aug 8, 2025 | Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, R... | CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit. | Class II | Breckenridge Pharmaceutical, Inc. |
| Jul 25, 2025 | Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, R... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Class II | Breckenridge Pharmaceutical, Inc. |
| Jul 15, 2025 | Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only,... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit | Class II | Breckenridge Pharmaceutical, Inc. |
| Jun 30, 2025 | Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, ... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Class II | Breckenridge Pharmaceutical, Inc. |
| Apr 14, 2025 | Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51... | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed inter... | Class II | Breckenridge Pharmaceutical, Inc |
| Apr 14, 2025 | Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, ... | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed inter... | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 26, 2025 | Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per ... | CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-dulox... | Class II | Breckenridge Pharmaceutical, Inc. |
| Feb 28, 2025 | Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, ... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Class II | Breckenridge Pharmaceutical, Inc. |
| Feb 28, 2025 | Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, ... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Class II | Breckenridge Pharmaceutical, Inc. |
| Feb 28, 2025 | Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, M... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Class II | Breckenridge Pharmaceutical, Inc. |
| Dec 6, 2024 | Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (N... | CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Class II | Breckenridge Pharmaceutical, Inc |
| Dec 6, 2024 | Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (ND... | CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Class II | Breckenridge Pharmaceutical, Inc |
| Oct 10, 2024 | Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, M... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Class II | Breckenridge Pharmaceutical, Inc |
| May 17, 2024 | Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mf... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Class II | Breckenridge Pharmaceutical, Inc |
| Apr 29, 2024 | Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Class II | Breckenridge Pharmaceutical, Inc |
| Apr 29, 2024 | Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Class II | Breckenridge Pharmaceutical, Inc |
| Apr 29, 2024 | Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, M... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 | Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Cent... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 | Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Cent... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 | Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 5199... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 | Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 | Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC 5... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 | Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 519... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 11, 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 | Breckenridge Pharmaceutical, Inc |
| Feb 24, 2020 | Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous ... | Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impuritie... | Class III | Breckenridge Pharmaceutical, Inc |
| Jan 24, 2020 | Solifenacin Succinate Tablets, 5mg, packaged in a) 30-count bottles (NDC 5199... | CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin ... | Class II | Breckenridge Pharmaceutical, Inc |
| Jan 24, 2020 | Solifenacin Succinate Tablets, 10 mg, packaged in a) 30-count bottles (NDC 51... | CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin ... | Class II | Breckenridge Pharmaceutical, Inc |
| Nov 6, 2018 | Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Di... | Failed Stability Specifications: Out-of-Specification results obtained for particle size distribu... | Class III | Breckenridge Pharmaceutical, Inc. |
| Oct 21, 2015 | Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, ... | Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was foun... | Class III | Breckenridge Pharmaceutical, 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.