Quick Facts at a Glance
- Recall Date
- November 13, 2025
- Hazard Level
- HIGH
- Brands
- GANIRELIX ACETATE, Lupin Pharmaceuticals, Inc.
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 4 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- GANIRELIX ACETATE, Lupin Pharmaceuticals, Inc.
- Product type
- Ganirelix Acetate Injection
- Model numbers
- Lot #: WB00006, Exp 12/31/2026
- UPC codes
- 70748-274, 70748-274-01
- Sold at
- Multiple Retailers
- Where affected
- FL, MA, MI, OH
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 13, 2025
Reported by FDA DRUG
December 17, 2025
RecallRadar source check
December 24, 2025
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Lupin Pharmaceuticals Inc. or your healthcare provider for guidance. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
About This Product
Ganirelix Acetate Injection is a medication used in assisted reproductive technology to prevent premature ovulation. Patients typically receive this injection under the guidance of a healthcare provider during fertility treatments.
Why This Is Dangerous
The recall stems from the presence of an impurity that failed to meet safety specifications. This impurity could lead to adverse health effects, making it unsafe for patient use.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers are advised to stop using the product immediately, as this could pose serious health risks. The inconvenience and potential health implications highlight the importance of monitoring medication quality.
Practical Guidance
How to identify if yours is affected
- Check the lot number on your Ganirelix Acetate Injection.
- Verify if it matches Lot #: WB00006.
- Look for the expiration date of December 31, 2026.
Where to find product info
Lot number and expiration date can be found on the packaging of the prefilled syringe.
What timeline to expect
Expect a refund or replacement to process within 4-6 weeks after contacting the manufacturer.
If the manufacturer is unresponsive
- Document all correspondence with the manufacturer.
- Follow up via phone or email after one week if no response is received.
How to prevent similar issues
- Always check for recall notices before using medications.
- Consult with healthcare providers regularly about medication safety.
- Look for FDA approval and recall history when purchasing medications.
Documentation advice
Keep receipts, product lot numbers, and any communication with the manufacturer for your records.
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Product Details
Ganirelix Acetate Injection comes in a 250 mcg/0.5 mL single-dose sterile prefilled syringe with a 27 gauge by 1/2' needle. The affected lot number is WB00006, with an expiration date of December 31, 2026. The product was distributed in Florida, Massachusetts, Michigan, and Ohio.
Key Facts
- Distributed in FL, MA, MI, OH
- Stop use immediately
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Safety Guide
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