Reported Apr 21, 2021 · Terminated

Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661,…

Jubilant Cadista Pharmaceuticals, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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?

  • Itraconazole Capsules, 100 mg, 30-count bottles, Rx only
  • Manufactured byJubilant Generics Ltd., Roorkee - 247661, India
  • Marketed byJubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-282-30
Lot codes and dates
    • Lot #s: IT119008B
    • Exp 05/2021
    • IT120001A
    • IT120002A
    • Exp 12/2021
Amount recalled
Lot #IT119008B - (4,128 Bottles); Lot #IT20001A - (3,984 Bottles); Lot #IT20002B - (4.080 Bottles)

Where it was sold

  • Nationwide

Why it was recalled

Failed Dissolution Specifications

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Apr 28, 2022 · Data as of Sep 19, 8:38 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.