Browse Drug Recalls
5 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 5 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 5 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 10, 2025 | HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syr... | Lack of Assurance of Sterility. | Class II | Samsung Bioepis Co., Ltd. |
| May 28, 2024 | Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuati... | Defective Container | Class III | Organon Llc |
| May 28, 2024 | Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuati... | Defective Container | Class III | Organon Llc |
| May 28, 2024 | Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuati... | Defective Container | Class III | Organon Llc |
| Jan 26, 2022 | Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuati... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
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.