FDA Recall D-0313-2025

ASEGUA THERAPEUTICS LLC · Foster City, CA

Class II Ongoing 433 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot# 24ASV002UA, Exp Date: 6/30/2028

Quantity: 18,541 cartons.

Reason for recall

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

Recall record

Recall number: D-0313-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide
Recall initiated: 2025-03-07
Classified by FDA Center: 2025-04-07
FDA published: 2025-04-16
Recalling firm: ASEGUA THERAPEUTICS LLC
Firm location: Foster City, CA

Drug identification

Brand name(s): SOFOSBUVIR AND VELPATASVIR
Generic name(s): VELPATASVIR AND SOFOSBUVIR
Manufacturer(s): Asegua Therapeutics LLC
NDC(s): 72626-2701
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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