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 is a medication used in assisted reproductive technology to prevent premature ovulation. Patients typically receive this injection under the guidance of a healthcare provider during fertility treatments.
The recall stems from the presence of an impurity that failed to meet safety specifications. This impurity could lead to adverse health effects, making it unsafe for patient use.
This recall is not part of a broader industry pattern.
Consumers are advised to stop using the product immediately, as this could pose serious health risks. The inconvenience and potential health implications highlight the importance of monitoring medication quality.
Lot number and expiration date can be found on the packaging of the prefilled syringe.
Expect a refund or replacement to process within 4-6 weeks after contacting the manufacturer.
Keep receipts, product lot numbers, and any communication with the manufacturer for your records.
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.
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