Ganirelix Acetate Injection recall: Impurity Out of Spec
Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lupin…
Why was Ganirelix Acetate Injection recalled?
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: WB00006, Exp 12/31/2026
- Product
- Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lupin…
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Quantity
- 32736 vials
- Distribution
- FL, MA, MI & OH
- Recall date
- December 17, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)