BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, all presentations, G...

FDA Recall #D-0086-2026 — Class II — July 30, 2025

Recall #D-0086-2026 Date: July 30, 2025 Classification: Class II Status: Ongoing

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).

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

GenoGenix LLC — Boca Raton, FL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Distribution

US Nationwide.

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated