Superpotent Prostate Cancer Drug Recalled

Tolmar Inc. is recalling a single lot of Eligard (leuprolide acetate) for superpotency. According to the October 4, 2023, US Food and Drug Administration (FDA) Enforcement Report, the constituted product contains higher than expected levels of leuprolide acetate.

The recall affects Eligard (leuprolide acetate) for injectable suspension, 7.5 mg (NDC 62935-753-75), from lot 13635A1 (Exp. 7/31/24). The product was manufactured by Tolmar Inc., Fort Collins, Colorado, for Tolmar Therapeutics Inc., Fort Collins, Colorado, and distributed throughout the United States.

Tolmar voluntarily initiated the recall September 12, 2023. On September 27, 2023, the FDA designated the recall Class III. Under the recall classification, use of the affected drug is not likely to cause harm.

Eligard is a prescription medication indicated for the palliative treatment of advanced prostate cancer.