Apotex Recalls Enalapril Maleate and Hydrochlorothiazide Tablets for Uniformity Issues
Apotex Inc. is recalling 4,584 bottles of Enalapril maleate and hydrochlorothiazide tablets, 10/25 mg, because the product may not meet blend uniformity specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 II, which typically corresponds to a Moderate severity score (2) when no specific injuries or hospitalizations are reported in the source text, and the hazard is a potential deviation from specifications rather than a confirmed acute danger.
Plain-English summary
Apotex Inc. is voluntarily recalling 4,584 bottles of Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count. The recall is due to a failure in content uniformity specifications, specifically that the product may not meet the limit for blend uniformity. The affected product is identified by Lot # KP4529 with an expiration date of 10/2015.
The recalled medication was distributed nationwide, including Hawaii and Puerto Rico. It is a prescription-only medication manufactured for Apotex Inc. by Apotex Research Private Limited in Bangalore, India.
Consumers with this medication should contact their healthcare provider or pharmacist for guidance on how to dispose of the product or obtain a replacement. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka…
- Manufacturer
- Apotex Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 4,584
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 #: KP4529
- Exp 10/2015
Distribution
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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