Eligard Injection (Tolmar) – Superpotent Drug (2023)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Tolmar, Inc.
Lot Codes / Batch Numbers
Lot: 13635A1, Exp. 07/31/2024
Products Sold
Lot: 13635A1, Exp. 07/31/2024
Tolmar, Inc. is recalling Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must b due to Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026