Sofosbuvir and Velpatasvir — Class II drug recall D-0313-2025
Ongoing recall by ASEGUA THERAPEUTICS LLC, reported 2025-04-16, distributed nationwide. Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
| Recall number | D-0313-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ASEGUA THERAPEUTICS LLC, Foster City, CA, United States |
| Recall initiated | 2025-03-07 |
| Classified | 2025-04-07 |
| Reported by FDA | 2025-04-16 |
| Distributed | Nationwide (US) |
| Quantity | 18,541 cartons |
| Reason classes | packaging |
| NDC | 72626-2701, 72626-2701-01 |
| Lot numbers | 24ASV002UA |
| Expiration dates | 2028-06-30 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0313-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.