US Drug Recall Register
Class III · Low risk Terminated Initiated Sep 12, 2023 (3 years ago)

Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.

What was recalled

Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted before use, NDC 62935-753-75, Manufactured by: Tolmar Inc., Fort Collins, CO 80526, For Tolmar Therapeutics Inc., Fort Collins, CO 80526.

Recalling firm
Tolmar, Inc.
NDC code
62935-753-75
Origin
CO, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1178-2023

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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