Reported Sep 24, 2014 · Terminated

Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx only, Manufactured by: Apotex…

Apotex Corp.

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: Apotex Corp. · 2400 N Commerce Pkwy Ste 400 · Weston, FL · 33326-3253

Is this the product you have?

  • Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx only
  • Manufactured byApotex Research Pvt. Ltd. Bangalore - 560 099, India NDC 60505-3759-9
Lot codes and dates
    • Lot # KK6086
    • exp 03/2015
    • UPC 360505375998
Amount recalled
1,494 bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurity/Degradation Specification; high out of specification for CAD II degradant

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 Oct 2, 2019 · Data as of Sep 19, 7:55 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.