Browse Drug Recalls
4 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 4 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 4 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 4, 2024 | Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle,... | Labeling: Label Mix-up | Class I | Azurity Pharmaceuticals, Inc. |
| Dec 8, 2023 | Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufa... | Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylid... | Class III | Azurity Pharmaceuticals, Inc. |
| Feb 15, 2023 | Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL... | cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials. | Class II | Azurity Pharmaceuticals, Inc. |
| Aug 24, 2021 | Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit... | Product Mix-up: Incorrect diluent component included in the kit. | Class I | Azurity Pharmaceuticals, 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.