Fulvestrant Injection 250mg/5mL — Class II drug recall D-1351-2022
Terminated recall by Zydus Pharmaceuticals (USA) Inc, reported 2022-08-24, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-1351-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States |
| Recall initiated | 2022-07-15 |
| Classified | 2022-08-17 |
| Reported by FDA | 2022-08-24 |
| Terminated | 2024-06-18 |
| Distributed | Nationwide (US) |
| Quantity | 1,116 boxes |
| Reason classes | specification failure |
| NDC | 70710-1688, 70710-1688-02, 70710-1688-08 |
| Lot numbers | B200076 |
| Expiration dates | 2024-01-31 |
Product
Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, Manufactured by: Cadila Healthcare Limited, Ahmadabad, India, Distributed by: Zydus Pharmaceuticals (USA ) Inc.m Pennington, NJ 08534, NDC 70710-1688-8.
Reason for recall
Failed Impurities/Degradation Specifications
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-1351-2022. 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.