# FDA recall D-0313-2025

> **ASEGUA THERAPEUTICS LLC** · Class II · drug recall initiated 2025-03-07.

## 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.

## Distribution

US Nationwide

## Key facts

- **Recall number:** D-0313-2025
- **Recalling firm:** ASEGUA THERAPEUTICS LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-03-07
- **Report date:** 2025-04-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Foster City, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0313-2025

## Citation

> AI Analytics. FDA recall D-0313-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0313-2025. Source: US FDA. Licensed CC0.

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