BPC-157 with Thymosin Beta-4 recalled from three lots over sterility
GenoGenix is recalling combined BPC-157/Thymosin Beta-4 for Injection across three lots for lack of assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: a loss of sterility assurance in an injectable creates an infection risk, and no injuries are reported.
Plain-English summary
BPC-157/Thymosin Beta-4 for Injection, at 10/10mg, 15/15mg and 15mg/15mg in all presentations, from GenoGenix, LLC of Boca Raton, Florida, is being recalled for lack of assurance of sterility. Some product is also labeled as manufactured for CELIA Health, Extension Health and Medical Health Institute.
The recall covers lots GG020525-001, GG060525-001 and GG062625-004 within expiry, distributed nationwide in the United States. The FDA has classified the recall as Class II.
Sterility matters for an injectable because the product is administered directly into the body. The enforcement record describes a loss of sterility assurance rather than confirmed contamination, and reports no injuries.
Healthcare providers and patients holding the affected lots should stop using them and contact the firm or their prescriber.
The recalled product
- 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).
- Manufacturer
- GenoGenix LLC
- Category
- Drug — Injectable
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot#: GG020525-001
- GG060525-001
- GG062625-004
- within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 57 recalled by GenoGenix LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 57 products in this recall →Related recalls
Same manufacturer · GenoGenix LLC
See all →- HighHydroxocobalamin B12 injection recalled across all lots for sterility assurance
FDA (Drugs) · 2025-10-15
- HighNAD+ injection recalled across all lots for lack of sterility assurance
FDA (Drugs) · 2025-10-15
- HighCerebrolysin injection recalled across all lots for lack of sterility assurance
FDA (Drugs) · 2025-10-15
- HighSermorelin lyophilized powder recalled from one lot over sterility assurance
FDA (Drugs) · 2025-10-15
- HighPyridoxine B6 injection recalled across all lots over sterility assurance
FDA (Drugs) · 2025-10-15
Same hazard · sterility assurance
See all →- SevereSI-BONE iFuse TORQ Implant System Recalled for Sterility Assurance Issues
FDA (Devices) · 2026-10-21
- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2026-07-08
Similar recalls
- SeverePromise Pharmacy Recalls Thymosin Beta-4 Injections Due to Sterility Concerns
FDA (Drugs) · 2019-02-20
- SeverePromise Pharmacy Recalls BPC 157 Injections Due to Sterility Concerns
FDA (Drugs) · 2019-02-20
- SevereFDA Recalls Thymosin Beta-4 Vials Due to Sterility Concerns
FDA (Drugs) · 2020-12-23
- HighInjectable Drug Recalled for Sterility Concerns Due to Manufacturing Defects
FDA (Drugs) · 2022-04-27
- SevereTestosterone Cypionate Injection Recalled Due to Sterility Concerns
FDA (Drugs) · 2015-09-23
- SevereFDA Recalls PGE Injectable Due to Sterility Assurance Concerns
FDA (Drugs) · 2014-01-15