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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Ganirelix Acetate Injection Recalled for Impurity Specification Failure

Agency Publication Date: December 10, 2025
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Summary

Lupin Pharmaceuticals Inc. is recalling 32,736 vials of Ganirelix Acetate Injection (250 mcg/0.5mL) due to the presence of an impurity called an acrylic acid adduct that exceeds safety specifications. This medication is a prescription injectable used in fertility treatments and was distributed in prefilled syringes. Consumers who have this medication should check their lot number and contact their healthcare provider immediately.

Risk

The product contains impurities that fell out of the required quality specifications during testing, which may affect the safety or efficacy of the medication. While no specific injuries have been reported, using medication with unexpected degradation products can pose health risks or lead to unexpected side effects.

What You Should Do

  1. Check your Ganirelix Acetate Injection packaging for Lot #: WB00006 and an expiration date of 12/31/2026.
  2. If you have health concerns or are unsure if you should continue your treatment, contact your healthcare provider or pharmacist immediately.
  3. Return any unused product to the place of purchase for a refund, throw it away, or contact Lupin Pharmaceuticals Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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: Ganirelix Acetate Injection (250 mcg/0.5mL)
Variants: Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only
Lot Numbers:
WB00006 (Exp 12/31/2026)
NDC:
70748-274-01

Recall #: D-0220-2026; Quantity: 32736 vials

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97990
Status: Active
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: Retail Pharmacies; Healthcare Providers
Manufactured In: India, United States
Units Affected: 32736 vials
Distributed To: Florida, Massachusetts, Michigan, Ohio

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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 ยท 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.