Sofosbuvir and Velpatasvir (ASEGUA) – Defective Container (2025)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
ASEGUA THERAPEUTICS LLC
Lot Codes / Batch Numbers
Lot# 24ASV002UA, Exp Date: 6/30/2028
Products Sold
Lot# 24ASV002UA, Exp Date: 6/30/2028
ASEGUA THERAPEUTICS LLC is recalling Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Only, Manufact due to Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026