The Recall Desk
HighFDA (Drugs)·D-0093-2026·Announced 2025-10-15

Retatrutide for Injection recalled for sterility assurance failure

GenoGenix LLC is recalling Retatrutide for Injection 60mg vials due to lack of assurance of sterility. The affected lot was distributed nationwide.

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 drug recall for an injectable product with lack of sterility assurance and no reported illnesses or injuries. Per the severity rubric, recalls with theoretical hazards and no reported illness are at most Score 3. The critical importance of sterility for injectable medications and the Class II classification justify a 'High' severity.

Plain-English summary

GenoGenix LLC is recalling one lot of Retatrutide for Injection, 60mg/10mL vials, due to lack of assurance of sterility. The recalled lot is GG021125-019, which is within its expiration date and was distributed nationwide.

Sterility is essential for the safety of injectable medications. The firm has determined it cannot assure that this product lot meets sterility requirements. Patients using this product should contact their healthcare provider to discuss this recall and potential next steps.

The recalled product

Product
Retatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Manufacturer
GenoGenix LLC
Category
Drug — Injectable
Hazard
  • sterility-failure
  • contamination

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 (2)

  • Lot#: GG021125-019
  • within expiry.

Distribution

Distributed nationwide across the United States.

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