Why it was recalled
Lack of Assurance of Sterility
Product description
Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health and Synergy Wellness 60mg, 10mL vial lyophilized.
Lot numbers, UPCs & expiration codes
Lots GG012925-005, GG021125-003, within expiry.
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0092-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 30, 2025
- FDA report date
- Oct 15, 2025
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GenoGenix LLC
Original FDA data
Every field from FDA enforcement report D-0092-2026, exactly as published.
Show all FDA fields
- City
- Boca Raton
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 97369
- Address
- 2840 Nw 2nd Ave Ste 204
- Code information
- Lots GG012925-005, GG021125-003, within expiry.
- Postal code
- 33431-6692
- Report date
- Oct 15, 2025
- Product type
- Drugs
- Recall number
- D-0092-2026
- Classification
- Class II
- Recalling firm
- GenoGenix LLC
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health and Synergy Wellness 60mg, 10mL vial lyophilized.
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Jul 30, 2025
- Initial firm notification
- Letter
- Center classification date
- Oct 21, 2025