Apotex Recalls Candesartan Cilexetil Tablets Due to Impurity Failures
Apotex Inc. is recalling Candesartan Cilexetil Tablets, 4 mg, because out-of-specification results were observed for specific impurities and total impurities.
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 impurity failures without reported illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Apotex Inc. is recalling Candesartan Cilexetil Tablets, 4 mg, 30-count bottles. The recall involves 13,177 bottles distributed nationwide. The affected products are identified by Lot numbers KR3924 and KR3926 with an expiration date of 11/15.
The recall was initiated because out-of-specification (OOS) results were observed for CAD-II, CAD-V, and Total Impurities. These failures indicate that the product did not meet the required specifications for impurities and degradation.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3618-3
- Manufacturer
- Apotex Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 13,177
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 (3)
- Lot #: KR3924
- KR3926
- Exp. 11/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Apotex Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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