Lupin Pharmaceuticals recalled 32,736 vials of Ganirelix Acetate Injection on November 13, 2025. The recall follows the discovery of impurities in the drug. Consumers and healthcare providers should stop using the product immediately to avoid health risks.
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Consumers and healthcare providers should stop using this product immediately. Contact Lupin Pharmaceuticals Inc. or your healthcare provider for guidance. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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Ganirelix Acetate Injection comes in a 250 mcg/0.5 mL single-dose sterile prefilled syringe with a 27 gauge by 1/2' needle. The affected lot number is WB00006, with an expiration date of December 31, 2026. The product was distributed in Florida, Massachusetts, Michigan, and Ohio.
The recall is due to failed impurities and degradation specifications, specifically out of specification results for Ganirelix acetate acrylic acid adduct impurity. This can pose significant health risks to patients.
No specific incidents or injuries have been reported in connection with this recall. The potential for harm remains high due to the nature of the impurity.
Stop using Ganirelix Acetate Injection immediately. Contact Lupin Pharmaceuticals Inc. or your healthcare provider for guidance on the next steps.
For more information, consumers can visit the FDA's recall page or contact Lupin Pharmaceuticals directly.
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