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Class II · ModerateActive recall

Ganirelix Acetate

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: WB00006, Exp 12/31/2026
Where it was soldFL, MA, MI & OH
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byLupin Limited, Nagpur - 441108, INDIA foreign manufacturer
Brand nameGANIRELIX ACETATE
Generic nameGANIRELIX ACETATE
Active ingredient(s)GANIRELIX ACETATE
Distributed by / forLupin Pharmaceuticals, Inc., Naples, FL 34108, United States
NDC70748-274-01
Show the full FDA record
Full product labelGanirelix 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
Recalling firmLupin Pharmaceuticals Inc.
DistributionFL, MA, MI & OH
Quantity32736 vials
Recall initiated2025-11-13
Report date2025-12-17
Recall completed—
Recall numberD-0220-2026
ClassificationClass II
FDA statusOngoing
Origin on fileNaples FL United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.