Semaglutide injection recalled from two lots for lack of sterility assurance
GenoGenix is recalling Semaglutide for Injection, 20 mg in 10 mL multi-dose vials, from two lots for lack of assurance of sterility.
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: 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
Semaglutide for Injection, at 20 mg and 20 mg/mL in 10 mL multi-dose vials, from GenoGenix, LLC of Boca Raton, Florida, is being recalled for lack of assurance of sterility. Some product is also labeled as manufactured for Synergy Wellness as a 20 mg, 10 mL lyophilized vial.
The recall covers lots GG021125-001 and GG031125-017 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
- Semaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness, 20 mg, 10mL vial lyophilized.
- 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 (3)
- Lot#: GG021125-001
- GG031125-017
- 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 →- 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
- SevereArrow drainage and thoracentesis kits contain recalled supplier drugs
FDA (Devices) · 2026-06-24