FDA Drugs recall ·
Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC… recall
- Recall number
- D-0089-2026
- Date
- (initiated July 30, 2025)
- Company / brand
- GenoGenix LLC
2840 Nw 2nd Ave Ste 204, Boca Raton, FL, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extension Health.
Why was it recalled?
Lack of Assurance of Sterility
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot#: GG053025-002 within expiry
Distribution
US Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0089-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.