Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Candesartan Cilexetil Tablets Recalled by Sandoz Inc Due to Failed Impurities/Degradation Specifications; 9 month stability timepoint

Date: December 31, 2015
Company: Sandoz Inc
Status: Terminated
Source: FDA (Drug)

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, 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

Quantity: 277,267 bottles

Why Was This Recalled?

Failed Impurities/Degradation Specifications; 9 month stability timepoint

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Sandoz Inc

Sandoz Inc has 30 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report