Pentosan for Injection recall — Class II (D-0078-2026) · pharmaranks
Class IIOngoing
Pentosan for Injection recall
FDA recall D-0078-2026 · initiated Jul 30, 2025
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility
Details
Product
Pentosan for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Recalling company
GenoGenix LLC
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
US Nationwide.
Initiated
Jul 30, 2025
FDA report date
Oct 15, 2025
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.