Sandoz Recalls Candesartan Cilexetil Tablets Due to Impurity Failures
Sandoz, Inc. is recalling 6,336 bottles of 16 mg candesartan cilexetil tablets because stability testing showed impurity levels exceeded specifications.
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 is defined as unlikely to cause adverse health consequences. The hazard involves chemical impurities exceeding specifications without reported illness, fitting the criteria for a moderate, precautionary recall.
Plain-English summary
Sandoz, Inc. is recalling 6,336 bottles of candesartan cilexetil tablets, 16 mg, 90-count bottles (NDC 0781-5938-92). The product is prescription-only and was manufactured for Sandoz, Inc. by Mylan Laboratories Limited in Hyderabad, India. The specific lot affected is 3007330, with an expiration date of 11/2014.
The recall was initiated due to failed impurities and degradation specifications. Specifically, an Out of Specification (OOS) result was generated for the 18-month stability time point regarding the ketone cilexetil impurity and total impurities. The source text does not report any illnesses or injuries associated with this recall.
The product was distributed nationwide. Consumers and healthcare providers should stop using the affected lot and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- 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
- Manufacturer
- Sandoz, Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 6,336
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 3007330
- Exp 11/2014
Distribution
Distributed nationwide across the United States.
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