Severity
Moderate
ModerateClass IIOngoing
FDA Drug recall · Reported April 16, 2025
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
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
Asegua Therapeutics LLC recalled Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Onl… - a moderate-severity action.
Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Onl… was recalled by Asegua Therapeutics LLC in April 16, 2025. Reason: Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.. Check the official notice for the remedy. Verify recall #D-0313-2025 with the FDA Drug before acting.
The recall
Asegua Therapeutics LLC issued this moderate-severity FDA Drug recall-Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton..
- Moderate
- severity level
- Class II
- classification
- April 16, 2025
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0313-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0313-2025) was formally reported on April 16, 2025, with the manufacturer initiating the action on March 7, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Asegua Therapeutics LLC is listed as the recalling firm, operating out of Foster City, CA. Federal records list the affected scope as 18,541 cartons..
The documented reason for this recall is: Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton. Distribution data in the federal record shows the product reached: US Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
18,541 cartons.
Related Recalls
6
5 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0313-2025 |
| Date reported | April 16, 2025 |
| Date initiated | March 7, 2025 |
| Recalling firm | Asegua Therapeutics LLC |
| Firm location | Foster City, CA |
| Affected scope | 18,541 cartons. |
| Distribution | US Nationwide |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0313-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Asegua Therapeutics LLC. Units affected: 18,541 cartons..
Why was this product recalled? ▼
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 16, 2025. Severity: Moderate. Recall number: D-0313-2025.
Where was the recalled product distributed? ▼
Distribution: US Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0313-2025) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported April 16, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.