Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
candesartan cilexetil Recalled by Sandoz, Inc Due to Failed Impurities/Degradation Specifications: An Out of Specification (OOS)...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sandoz, Inc directly.
Affected Products
candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by Mylan Laboratories Limited Hyderabad, 500 034, India, NDC 0781-5938-92
Quantity: 6,336 bottles
Why Was This Recalled?
Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sandoz, Inc
Sandoz, Inc has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report