US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Mar 7, 2025 (1 years ago)

Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.

What was recalled

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 firm
Asegua Therapeutics LLC
NDC code
72626-2701-1
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0313-2025

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.