The Recall Desk
HighFDA (Drugs)·D-0089-2026·Announced 2025-10-15

Epithalon injection recalled due to unverified sterility assurance

GenoGenix LLC is recalling Epithalon for Injection, 20mg (Lot GG053025-002) due to lack of assurance of sterility. Distribution 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 is an FDA Class II recall involving lack of sterility assurance for an injectable drug product. While sterility assurance is critical for parenteral products, no actual contamination, illnesses, or injuries have been reported in the source material, placing this in the High severity category per the rubric.

Plain-English summary

Epithalon for Injection, 20mg, manufactured by GenoGenix LLC, is being recalled from US nationwide distribution. The recall affects all presentations of the product, specifically Lot GG053025-002, which remains within its expiration date.

The FDA is initiating this recall because the manufacturer cannot assure the product's sterility. Lack of sterility assurance in an injectable medication represents a significant safety concern.

Patients and healthcare providers who have obtained this product should stop its use and consult their healthcare provider or pharmacist for guidance.

The recalled product

Product
Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extension Health.
Manufacturer
GenoGenix LLC
Category
Drug — Injectable / Parenteral
Hazard
  • sterility-assurance

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#: GG053025-002 within expiry

Distribution

Distributed nationwide across the United States.

Related recalls

Same category