Recall archive / FDA drug enforcement
Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, ... — FDA record D-0220-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 13, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Quantity
- 32736 vials
- Agency-reported status
- Ongoing
- Source record identifier
- D-0220-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot #: WB00006, Exp 12/31/2026 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
FL, MA, MI & OH
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 17, 2025
- Recall initiation date
- Nov 13, 2025
- Center classification date
- Dec 8, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.