Browse Drug Recalls
9 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 9 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 9 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 29, 2026 | PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial,... | Discolored solution. The firm has received market complaints reporting green to dark green discol... | Class II | Shilpa Medicare Limited |
| Jul 29, 2026 | PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose via... | Discolored solution. The firm has received market complaints reporting green to dark green discol... | Class II | Shilpa Medicare Limited |
| Dec 14, 2020 | Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use On... | cGMP deviations: Vials may not be sealed correctly affecting sterility. | Class II | CIPLA |
| Dec 8, 2020 | Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: ... | CGMP Deviations | Class II | Shilpa Medicare Limited |
| Dec 8, 2020 | Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must... | CGMP Deviations | Class II | Shilpa Medicare Limited |
| Dec 8, 2020 | Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only,... | CGMP Deviations | Class II | Shilpa Medicare Limited |
| Dec 8, 2020 | Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use O... | CGMP Deviations | Class II | Shilpa Medicare Limited |
| Dec 8, 2020 | Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: ... | CGMP Deviations | Class II | Shilpa Medicare Limited |
| Dec 8, 2020 | Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use O... | CGMP Deviations | Class II | Shilpa Medicare Limited |
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.