The Recall Desk
HighFDA (Drugs)·D-0090-2026·Announced 2025-10-15

Sermorelin Injectable Powder Recalled for Sterility Assurance Issues

GenoGenix LLC is recalling a specific lot of Sermorelin injectable powder due to lack of assurance of sterility. The affected lot (GG062425-002) 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: This FDA Class II recall involves a risk-of-harm product (parenteral medication with unassured sterility). Although no illnesses or injuries have been reported, the lack of sterility assurance on an injectable medication represents a genuine risk, placing it in the High category per the rubric.

Plain-English summary

GenoGenix LLC is recalling Sermorelin Lyophilized powder for reconstitution (10mg vials, multi-dose) due to lack of assurance of sterility. The recalled product, lot GG062425-002, remains within its stated expiration date and was distributed nationwide.

Lack of assurance of sterility on this parenteral medication presents a potential risk to users. No illnesses or injuries have been reported in connection with this recall.

Consumers should consult their healthcare provider about obtaining a replacement product or alternative treatment options.

The recalled product

Product
Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Manufacturer
GenoGenix LLC
Category
Drug — Injectable Powder
Hazard
  • lack-of-sterility

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)

  • Lot#: GG062425-002 within expiry.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category