Ganirelix Acetate Injection, 250 mcg/0.5mL

Lupin Pharmaceuticals Inc. has recalled Ganirelix Acetate Injection, 250 mcg/0.5mL, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on December 17, 2025 and was initiated on November 13, 2025. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Ganirelix Acetate Injection, 250 mcg/0.5mL, with approximately 32736 vials affected. The company behind the recall is Lupin Pharmaceuticals Inc., based in Naples, FL. The FDA describes the product as: “Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70…”

Why was Ganirelix Acetate Injection, 250 mcg/0.5mL recalled?

According to the FDA, the stated reason for the recall is: “Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.” In plain terms, this recall relates to a chemical impurity.

This recall involves an unwanted chemical detected in the medicine — often a nitrosamine impurity, which regulators limit because long-term exposure above set levels may increase health risks. Regulators recall affected batches as a precaution. Health authorities generally advise talking to a doctor or pharmacist before stopping a prescribed medicine.

What should you do?

If you think you may have bought Ganirelix Acetate Injection, 250 mcg/0.5mL, compare it against the product description and identifying codes (Lot #: WB00006, Exp 12/31/2026) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Lupin Pharmaceuticals Inc. or your local health authority.

About this recall

This recall was distributed in FL. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.