Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Eligard (leuprolide acetate) for injectable suspension Recalled by Tolmar, Inc. Due to Superpotent Drug - Higher than expected levels of...

Date: September 12, 2023
Company: Tolmar, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Tolmar, Inc. directly.

Affected Products

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.

Quantity: 2990 cartons

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Tolmar, Inc.

Tolmar, Inc. has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report