Ganirelix Acetate Injection — Class II drug recall D-0320-2021
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2021-04-14, distributed in NJ. Failed Impurities/Degradation Specifications
| Recall number | D-0320-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2021-03-15 |
| Classified | 2021-04-02 |
| Reported by FDA | 2021-04-14 |
| Terminated | 2023-06-06 |
| Distributed | NJ |
| Quantity | 91,211 syringes |
| Reason classes | specification failure |
| NDC | 55566-1000-01 |
| Lot numbers | JKU1212A, JKU1503A, JKU1504A, JKU1505A, JKU1506A, JKU3313A, JKU3314A |
| Expiration dates | 2021-03, 2021-08 |
Product
Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals, Inc., Parsippany, NJ 07054 USA, Manufactured by: Sun Pharmaceutical Industries Ltd, Halol, Gujarat, India Made in India, NDC 55566-1000-1.
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-0320-2021. 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.