Injectable Exosome Solution Recalled for Lack of Sterility Assurance
GenoGenix has recalled Elite Stack MSC Exosome Reconstitution Solution due to inability to assure sterility of all lots. The injectable product was distributed nationwide and should not be administered pending further guidance.
What this means for you
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: FDA Class II injectable product recall with lack of sterility assurance and no reported illnesses, injuries, or confirmed contamination. Per the rubric, this is a risk-of-harm product without reported injury, which scores as High (3).
Plain-English summary
GenoGenix, LLC is recalling Elite Stack MSC Exosome Reconstitution Solution for Injection, all strengths and presentations. The product is also labeled as manufactured for Extension Health and includes formulations of 22 billion and 44 billion exosomes per vial in 8mL of solution within 10mL vials.
The recall is due to lack of assurance of sterility. Sterility testing or verification procedures have not been completed in a manner that provides adequate assurance that all lots meet sterility requirements, which is a critical specification for injectable products.
All lots within their current expiration dates are included in the recall. The product was distributed to customers nationwide. Patients and healthcare providers should not use remaining doses of this product. Those with questions should contact GenoGenix or their healthcare provider.
The recalled product
- Product
- Elite Stack MSC Exosome Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health, a) 22 billion per vial, 8mL of solution in 10mL vial, b) 44 billio
- Manufacturer
- GenoGenix LLC
- Category
- Drug — Injectable Solution
- Hazard
- sterility-assurance
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 (1)
- All lots within expiry.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27