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

FDA recall notice · announced April 16, 2025 · Asegua Therapeutics

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

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

Notes

Distribution: US Nationwide
Lot/code information: Lot# 24ASV002UA, Exp Date: 6/30/2028
Quantity: 18,541 cartons.
Status: Ongoing
Products in this recall event:
- 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 (D-0313-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.