The Recall Desk
HighFDA (Drugs)·D-0083-2026·Announced 2025-10-15

Semaglutide with B12 Injectable Recalled for Sterility Assurance Issues

GenoGenix LLC is recalling Semaglutide with B12 for Injection nationwide due to lack of assurance of sterility. Consumers should stop using this product and consult their healthcare provider.

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 an FDA Class II recall involving lack of sterility assurance in an injectable medication, which is a high-risk product category. However, no illnesses, injuries, or hospitalizations have been reported in the source text, so the severity is limited to Score 3 (High) per the rubric criterion for risk-of-harm products where injury has not been reported.

Plain-English summary

GenoGenix LLC is recalling all lots of Semaglutide with B12 for Injection in all strengths and presentations. The recall applies to products within their expiration dates distributed nationwide in the United States.

The recall was issued due to lack of assurance of sterility. Sterility is a critical requirement for injectable medications.

Consumers with this product should discontinue use and consult their healthcare provider. Healthcare providers should inform patients who received this medication about the recall.

The recalled product

Product
Semaglutide with B12 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Manufacturer
GenoGenix LLC
Category
Drug — Injectable
Hazard
  • non-sterile
  • infection-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