Class II Recall Issued for Ganirelix Injection After Detection of Degradation Impurity
Key Takeaways
- Lupin Pharmaceuticals has issued a voluntary Class II recall of one lot of ganirelix acetate injection due to out-of-specification impurity levels.
- The recall affects 32 736 single-dose prefilled syringes distributed to Florida, Massachusetts, Michigan, and Ohio.
- Elevated levels of a ganirelix acetate acrylic acid adduct impurity may impact product quality and safety, prompting regulatory action.
Lupin Pharmaceuticals has initiated a voluntary recall of Ganirelix Acetate Injection 250 mcg/0.5 mL, supplied in single-dose sterile prefilled syringes. The affected lot, WB00006, carries an expiration date of December 31, 2026 and includes 32 736 units manufactured by Lupin Limited in India for the company’s US division. The recall is listed under Recall Number D-0220-2026 and pertains specifically to NDC 70748-274-01.
The recall was triggered after the product failed impurities and degradation specifications, specifically showing out-of-specification results for a ganirelix acetate acrylic acid adduct impurity. While the US Food and Drug Administration (FDA) has classified the action as Class II, indicating reversible health risks, deviations in impurity levels may affect product stability, potency, or safety—especially relevant in fertility treatment protocols where precise dosing is critical. No public press release has been issued, but multiple communication channels were used to alert consignees.
According to FDA Event ID 97990, the recall was initiated on November 13, 2025 and classified on December 8, 2025. The recall remains ongoing, with distribution limited to Florida, Massachusetts, Michigan, and Ohio. Lupin Pharmaceuticals, headquartered in Naples, Florida, is listed as the recalling firm. No termination date has been posted to date.
Ganirelix acetate is a gonadotropin-releasing hormone (GnRH) antagonist indicated for inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation during assisted reproductive technologies (ART), such as in vitro fertilization (IVF).
Reference
FDA. Enforcement Report. December 17, 2025. Accessed December 18, 2025. https://www.accessdata.fda.gov/scripts/ires/index.cfm
