Is Leuprolide recalled?

Q: Is Leuprolide recalled?

Not currently. Leuprolide was recalled 7 time(s) in the past, all now closed (most recent Sep 12, 2023). There is no active FDA recall for Leuprolide right now.

Not under an active recall. Leuprolide was recalled 7 times in the past — all now closed. Most recent: Sep 12, 2023.

Most common reason: Packaging defect (5 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Leuprolide. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Leuprolide recalls on record

none so far in 2026; 7 on record, newest first

Sep 12, 2023 Class III · Low risk

Eligard (leuprolide acetate)

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

Terminated Wrong potency / content Tolmar, Inc. NDC 62935-753-75 D-1178-2023

Nov 7, 2014 Class II · Moderate risk

Leuprolide 50 mcg/0.1 mL Micro Lupron Kit

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Perry Drug Inc. NDC 88888-1124-57 D-0262-2015