Recalls / Class II
Class IID-0092-2026
Product
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.
- Affected lot / code info
- Lots GG012925-005, GG021125-003, within expiry.
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- GenoGenix LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2840 Nw 2nd Ave Ste 204, Boca Raton, Florida 33431-6692
Distribution
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2025-07-30
- FDA classified
- 2025-10-21
- Posted by FDA
- 2025-10-15
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0092-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.