Browse Drug Recalls
3 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3 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 3 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 17, 2026 | CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-V... | Lack of Assurance of Sterility | Class II | Chiesi USA, Inc. |
| May 31, 2019 | ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx o... | Failed Dissolution Specifications: Out of specification result for dissolution. | Class II | Chiesi USA, Inc. |
| May 31, 2019 | Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distri... | Failed Dissolution Specifications: Out of specification result for dissolution. | Class II | Chiesi 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.