Ganirelix Acetate Injection — Class II drug recall D-0220-2026
Ongoing recall by Lupin Pharmaceuticals Inc., reported 2025-12-17, distributed in FL, MA, MI, OH. Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid
| Recall number | D-0220-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Naples, FL, United States |
| Recall initiated | 2025-11-13 |
| Classified | 2025-12-08 |
| Reported by FDA | 2025-12-17 |
| Distributed | FL, MA, MI, OH |
| Quantity | 32,736 vials |
| Reason classes | specification failure |
| NDC | 70748-0274, 70748-0274-01 |
| Lot numbers | WB00006 |
| Expiration dates | 2026-12-31 |
Product
Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-274-01
Reason for recall
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
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-0220-2026. 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.