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

[pending] Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton

Pending LLM rewrite. Source: FDA_DRUG D-0089-2026.

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: Pending LLM scoring against the rubric.

Plain-English summary

Lack of Assurance of Sterility

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

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.