Class II

Drug Recall: 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

ASEGUA THERAPEUTICS LLC · March 7, 2025

Reason for Recall

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

Product Description

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

Distribution

US Nationwide

States Affected

NATIONWIDE

Quantity Affected

18,541 cartons.

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0313-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.