Sofosbuvir and Velpatasvir recall
FDA recall D-0313-2025 · initiated Mar 7, 2025
ASEGUA THERAPEUTICS LLC recalled Sofosbuvir and Velpatasvir in Mar 2025 — an FDA Class II recall (D-0313-2025) because Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 18,541 cartons.
Details
- 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
- Recalling company
- ASEGUA THERAPEUTICS LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide
- Initiated
- Mar 7, 2025
- FDA report date
- Apr 16, 2025
Frequently asked
- Was Sofosbuvir and Velpatasvir recalled?
- ASEGUA THERAPEUTICS LLC recalled Sofosbuvir and Velpatasvir in Mar 2025 — an FDA Class II recall (D-0313-2025) because Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Sofosbuvir and Velpatasvir recalled?
- Per the FDA enforcement record, the reason for recall D-0313-2025 was: Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
- Is a recalled Sofosbuvir and Velpatasvir dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Sofosbuvir and Velpatasvir are affected?
- Distributed: US Nationwide. The recall covers these lots — Lot# 24ASV002UA, Exp Date: 6/30/2028. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0313-2025.