Medications & Supplements/Prescription Drugs

Eligard (leuprolide acetate) Recalled for High Potency Risk

Agency Publication Date: September 26, 2023

Summary

Tolmar, Inc. is voluntarily recalling 2,990 cartons of Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month. The recall was initiated because the medication was found to be superpotent, containing higher than expected levels of leuprolide acetate once mixed for use. No incidents or injuries have been reported to date in connection with this issue.

Risk

Patients receiving this superpotent medication may be exposed to higher doses of the active ingredient than intended, which could potentially lead to unexpected side effects or adverse clinical outcomes.

What You Should Do

This recall affects Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, sold in 2,990 cartons with NDC code 62935-753-75.
Identify affected products by checking for lot number 13635A1 and an expiration date of 07/31/2024 on the product packaging.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Tolmar, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Eligard (leuprolide acetate) for injectable suspension (7.5 mg)

Variants: 7.5 mg dose, Monthly suspension, Sterile, Rx Only

Lot Numbers:

13635A1 (Exp. 07/31/2024)

NDC:

62935-753-75

Must be reconstituted before use; Recall #: D-1178-2023.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93044

Status: Resolved

Manufacturer: Tolmar, Inc.

Sold By: Pharmacies; Healthcare Providers

Manufactured In: United States

Units Affected: 2990 cartons

Distributed To: Nationwide

Agency Last Updated: September 27, 2023

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, sold in 2,990 cartons with NDC code 62935-753-75.

Identify affected products by checking for lot number 13635A1 and an expiration date of 07/31/2024 on the product packaging.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Tolmar, Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.