D-0089-2026 Class II Ongoing
FDA drug recall D-0089-2026 was initiated by GenoGenix LLC on Jul 30, 2025 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 15, 2025
- Initiation Date
- Jul 30, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extension Health.
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
US Nationwide.
Code Information
Lot#: GG053025-002 within expiry
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0089-2026
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026