FDA recall D-0086-2026

GenoGenix LLC · Class II · drug

Product

BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health, Extension Health and Medical Health Institute (MHI).

Reason for recall

Lack of Assurance of Sterility

Distribution

US Nationwide.

Key facts

Status
Ongoing
Initiation date
2025-07-30
Report date
2025-10-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Boca Raton, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0086-2026