B12 Methylcobalamin Injectable Recalled Due to Lack of Sterility Assurance
GenoGenix LLC is recalling all strengths of B12 Methylcobalamin for Injection nationwide due to lack of assurance of sterility. All lots within expiry are affected.
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: This is a Class II recall of an injectable drug with no reported illnesses or injuries. The hazard—lack of sterility assurance—represents a risk of harm from potential contamination, but remains theoretical absent adverse events. Injectable medications carry inherent higher risk due to direct bloodstream access, placing this above "Moderate" but not meeting "Severe" criteria absent reported harms.
Plain-English summary
GenoGenix LLC is recalling all lots of B12 Methylcobalamin for Injection, all strengths and presentations, due to lack of assurance of sterility. The product is distributed nationwide.
The issue is a manufacturing defect: the company cannot assure that the injectable product meets sterility requirements. Injectable medications must be sterile to prevent contamination in the bloodstream.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. Unused product should be returned to the pharmacy or distributor.
The recalled product
- Product
- B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as, manufactured for Synergy Wellness.
- Manufacturer
- GenoGenix LLC
- Category
- Drug — Injectable / Parenteral
- Hazard
- lack-of-sterility
- contamination-risk
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