Class II · Moderate risk
Thymosin Beta-4
Lack of Assurance of Sterility
BPC-157/Thymosin Beta-4 for Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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).
Drug: Thymosin
- Recalling firm
- GenoGenix LLC
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0086-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Thymosin recalls
See all
Class II · Moderate risk
Thymosin Beta - 4
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
Thymosin Alpha
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
Thymosin Beta-4
Lack of sterility assurance.
Other recalls by GenoGenix LLC
All 2025 recalls
Class I · High risk
NAD+ (Nicotinamide adenine dinucleotide)
Microbial Contamination of Sterile Products: elevated endotoxin levels
Class II · Moderate risk
Retatrutide for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide for Injection
Lack of Assurance of Sterility
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