FDAClass IIIOctober 4, 2023

Eligard recall: Superpotent

Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted before use, NDC 62935-753-75…

Why was Eligard recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: 13635A1, Exp. 07/31/2024

Product
Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted before use, NDC 62935-753-75…
Recalling firm
Tolmar, Inc.
Quantity
2990 cartons
Distribution
Nationwide in the US.
Recall date
October 4, 2023
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls