Reported Oct 4, 2023 · Terminated

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

Tolmar, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Tolmar, Inc. · 701 Centre Ave · Fort Collins, CO · 80526-1843

Is this the product you have?

  • Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted before use, NDC 62935-753-75
  • Manufactured byTolmar Inc., Fort Collins, CO 80526, For Tolmar Therapeutics Inc., Fort Collins, CO 80526
Lot codes and dates
  • Lot
    • 13635A1
    • Exp. 07/31/2024
Amount recalled
2990 cartons

Where it was sold

  • Nationwide

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Oct 3, 2024 · Data as of Sep 19, 5:08 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.