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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

Jubilant Cadista Pharmaceuticals, Inc.: Valsartan Tablets Recalled Due to Incorrect Excipient Ingredient Size

Agency Publication Date: June 7, 2018
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Summary

Jubilant Cadista Pharmaceuticals is voluntarily recalling 4,680 bottles of Valsartan (320 mg) tablets, a prescription medication used to treat high blood pressure and heart failure. The recall was initiated because certain batches were manufactured with a larger size grade of the inactive ingredient Crospovidone than is required by the product's specifications. This defect affects approximately 2,328 bottles of lot VR417065A and 2,352 bottles of lot VR417066A, which were distributed to wholesalers and pharmacies in several U.S. states.

Risk

The use of an incorrect size grade of an inactive ingredient can potentially affect how the tablet dissolves or is absorbed by the body. While the risk level is classified as low, the product does not meet its approved quality standards.

What You Should Do

  1. Check your prescription bottle to see if you have Valsartan Tablets USP, 320 mg, 90-count bottles with NDC 59746-363-90.
  2. Verify the lot numbers and expiration date on the side of the bottle: look for Lot VR417065A or Lot VR417066A with an expiration date of 10/2019.
  3. If your medication is part of the recalled lots, do not stop taking it until you have spoken with your healthcare provider or pharmacist, as stopping blood pressure medication abruptly can be dangerous.
  4. Contact your healthcare provider or pharmacist for guidance on obtaining a replacement and return any unused product to the pharmacy for a refund.
  5. Contact Jubilant Cadista Pharmaceuticals at their Salisbury, Maryland facility for further instructions regarding this recall.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return product.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund and contact the manufacturer for further instructions.

Affected Products

Product: Valsartan Tablets USP, 320 mg (90 tablet bottle)
Model:
NDC 59746-363-90
D-0876-2018
Lot Numbers:
VR417065A (Exp 10/2019)
VR417066A (Exp 10/2019)
Date Ranges: Expiration Date: 10/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80133
Status: Resolved
Manufacturer: Jubilant Cadista Pharmaceuticals, Inc.
Sold By: pharmacies; wholesalers
Manufactured In: India, United States
Units Affected: 2,328 bottles (Lot VR417065A) and 2,352 bottles (Lot VR417066A)
Distributed To: Indiana, Michigan, Mississippi, North Carolina, New Jersey, New York, Ohio

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.