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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Asegua Sofosbuvir and Velpatasvir Tablets Recalled for Defective Packaging

Agency Publication Date: April 7, 2025
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Summary

Asegua Therapeutics LLC is recalling 18,541 cartons of Sofosbuvir and Velpatasvir (400 mg/100 mg) tablets because the blister packs may not be properly sealed. This defect results in tablets being loose within the carton instead of protected in their individual blister slots. The recall affects one specific lot of 28-count cartons (2x14 blister cards) manufactured for Asegua Therapeutics LLC, an affiliate of Gilead Sciences, Inc.

Risk

Blister packs that are not properly sealed can expose the medication to air and moisture, which may degrade the tablets and reduce their effectiveness. Additionally, tablets being loose in the carton increases the risk of the pills being damaged, lost, or potentially contaminated.

What You Should Do

  1. This recall affects Sofosbuvir and Velpatasvir (400 mg/100 mg) tablets, sold in 28-count cartons (2x14 blister cards) under NDC 72626-2701-1.
  2. Identify if your medication is affected by checking the carton for lot number 24ASV002UA and an expiration date of June 30, 2028.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Asegua Therapeutics LLC for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Sofosbuvir and Velpatasvir (400 mg/100 mg tablets, 28 tablets)
Variants: 400 mg/100 mg, 28 tablets, 2x14 blister cards, Rx Only
Lot Numbers:
24ASV002UA (Exp 6/30/2028)
NDC:
72626-2701-1

Manufactured for Asegua Therapeutics LLC (an affiliate of Gilead Sciences, Inc.) and made in Ireland.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96434
Status: Active
Manufacturer: ASEGUA THERAPEUTICS LLC
Sold By: Retail Pharmacies; Specialty Pharmacies
Manufactured In: Ireland
Units Affected: 18,541 cartons.
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.