Sandoz Recalls Candesartan Cilexetil Tablets Due to Impurity Failures
Sandoz Inc. is recalling Candesartan Cilexetil Tablets, 16 mg, because the product failed impurities and degradation specifications at a 9-month stability timepoint.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The specific failure of impurity specifications without reported illness supports a Moderate rating.
Plain-English summary
Sandoz Inc. is recalling Candesartan Cilexetil Tablets, 16 mg, in 30-count and 90-count bottles. The recall involves 277,267 bottles distributed nationwide. The product is manufactured by Mylan Laboratories Limited in India for Sandoz Inc.
The recall was initiated because the product failed impurities and degradation specifications at a 9-month stability timepoint. This indicates that the medication may not meet quality standards regarding its chemical composition over time.
Patients and healthcare providers should check their inventory for the specific NDC numbers and lot codes listed in the recall notice. Affected lots include various expiration dates ranging from December 2015 to January 2017. Consumers should contact their healthcare provider for guidance on alternative treatments or replacements.
The recalled product
- Product
- 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
- Manufacturer
- Sandoz Inc
- Category
- Drug — Prescription Medication
- Affected units
- 277,267
Distribution
Distributed nationwide across the United States.
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