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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Viatris Candesartan Cilexetil Tablets Recalled for Impurity Issues

Agency Publication Date: September 14, 2021
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Summary

Viatris is recalling 21,094 units of Candesartan Cilexetil (16 mg), a medication used to treat high blood pressure, because the tablets failed to meet impurity and degradation specifications. The recall specifically affects 30-count bottles manufactured for Mylan Pharmaceuticals Inc. No incidents or injuries have been reported to date regarding this issue.

Risk

The tablets were found to have levels of a related impurity compound that exceeded safety specifications. Taking medication with unexpected impurities may lead to unknown long-term health effects.

What You Should Do

  1. The recalled products are 30-count bottles of Candesartan Cilexetil Tablets, USP 16 mg, marked with NDC 0378-3231-93 and lot number 3107334 (Expiration Date: October 2021).
  2. 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 the manufacturer for further instructions.
  3. 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: Candesartan Cilexetil Tablets, USP 16 mg (30 count bottles)
Variants: 16 mg, Tablet
Lot Numbers:
3107334 (Exp. October 2021)
NDC:
0378-3231-93

Manufactured for Mylan Pharmaceuticals Inc., Morgantown, WV 26505

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88609
Status: Resolved
Manufacturer: Viatris
Sold By: Pharmacies nationwide
Manufactured In: United States
Units Affected: 21,094
Distributed To: Nationwide

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.