← FDA ENFORCEMENT
D-0086-2026Class II

GenoGenix LLC

Recalling firm
GenoGenix LLC
Product type
Drug
Status
Ongoing
Report date
2025-10-15
Distribution
US Nationwide.
Firm state
FL
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility

Product description

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).

Code / lot info

Lot#: GG020525-001, GG060525-001, GG062625-004, within expiry.

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.