The Recall Desk
HighFDA (Drugs)·D-0060-2026·Announced 2025-10-15

Lipo MIC +B12 Methylcobalamin Injection Recalled Over Sterility

GenoGenix LLC is recalling Lipo MIC +B12 Methylcobalamin for Injection nationwide due to lack of assurance of sterility. Consumers should discontinue use and contact 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: FDA Class II recall involving a risk-of-harm product (injectable pharmaceutical) with identified sterility deficiency. No illnesses or injuries have been reported, making this a precautionary recall based on process controls rather than documented patient harm.

Plain-English summary

GenoGenix LLC is recalling all strengths and presentations of Lipo MIC +B12 Methylcobalamin for Injection due to lack of assurance of sterility. The product was distributed nationwide.

Sterility assurance is critical for injectable pharmaceutical products.

Consumers who have obtained this product should discontinue use and contact their healthcare provider. Any adverse events should be reported to the FDA.

The recalled product

Product
Lipo MIC +B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Manufacturer
GenoGenix LLC
Hazard
  • sterility-assurance-failure
  • 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.