US Drug Recall Register
Class III · Low risk Terminated Initiated Dec 31, 2015 (11 years ago)

Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Failed Impurities/Degradation Specifications; 9 month stability timepoint

What was recalled

Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540

Recalling firm
Sandoz Inc
NDC code
00781-5938-31
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0659-2016

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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