Class IIReported 2025-10-15

Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extension Health.

Recalled by GenoGenix LLC

Reason for Recall

Lack of Assurance of Sterility

Recall Number

D-0089-2026

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-07-30

Reported

2025-10-15

Distribution

US Nationwide.

Code Info

Lot#: GG053025-002 within expiry

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.