Fulvestrant Injection 250 mg/5 mL — Class II drug recall D-0820-2021
Terminated recall by Glenmark Pharmaceuticals Inc., USA, reported 2021-09-29, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0820-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2021-08-27 |
| Classified | 2021-09-21 |
| Reported by FDA | 2021-09-29 |
| Terminated | 2023-10-04 |
| Distributed | Nationwide (US) |
| Quantity | 28,658 cartons |
| Reason classes | sterility |
| NDC | 68462-0317, 68462-0317-32, 68462-0317-40 |
| Lot numbers | 30200014, 30200015, 30200016, 30200036, 30200038, 30200039, 30200040, 30210001, 30210002, 30210003, 30210004, 30210005, 30210006, 30210014, 30210022, 30210028, 30210029, 30210030, 30210031 |
| Expiration dates | 2022-04-30, 2022-05-31, 2022-09-30, 2022-12-31, 2023-01-31, 2023-02-28 |
Product
Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx only NDC 68462-317-32
Reason for recall
Lack of Assurance of Sterility
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0820-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.