Sofosbuvir and Velpatasvir recall — Class II (D-0313-2025) · pharmaranks
Class IIOngoing
Sofosbuvir and Velpatasvir recall
FDA recall D-0313-2025 · initiated Mar 7, 2025
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
Details
Product
Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Only, Manufactured for: Asegua Therapeutics LLC an affiliate of Gilead Sciences, Inc., Foster City, CA 94404, Made in Ireland, NDC# 72626-2701-1
Recalling company
ASEGUA THERAPEUTICS LLC
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
US Nationwide
Initiated
Mar 7, 2025
FDA report date
Apr 16, 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.