Reported Jun 13, 2018 · Terminated

Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India,…

Jubilant Cadista Pharmaceuticals, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Jubilant Cadista Pharmaceuticals, Inc. · 207 Kiley Dr · Salisbury, MD · 21801-2249

Is this the product you have?

  • Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only
  • Manufactured byJubilant Generics Ltd. Roorkee - 247661, India
  • Marketed byJubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90
Lot codes and dates
    • Lot #: VR417065A
    • VR417066A
    • Exp 10/2019
Amount recalled
2,328 bottles (Lot VR417065A) and 2,352 bottles (Lot VR417066A)

Where it was sold

Why it was recalled

Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jan 8, 2020 · Data as of Sep 19, 5:50 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.