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Drug FDA Class II Ongoing Quality

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

ASEGUA THERAPEUTICS LLC Published Apr 16, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact ASEGUA THERAPEUTICS LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Affected products (1)

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

SOFOSBUVIR AND VELPATASVIR · 18,541 cartons.

NDC: 72626-2701, 72626-2701-1
Lot codes: 24ASV002UA
Code info: Lot# 24ASV002UA, Exp Date: 6/30/2028

Affected areas

Nationwide

Timeline

  1. Initiated
    Mar 7, 2025
  2. Published
    Apr 16, 2025
Recall number
D-0313-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.