FDAFDA · Food and drugs·Recall number D-0089-2026
Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extension Health.
Published October 15, 2025 · Recall initiated: July 30, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GenoGenix LLC
- Distributor
- US Nationwide.
- Lot
- Lot#: GG053025-002 within expiry
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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