Aidarex Recalls Enalapril Maleate Tablets Due to Impurity Failures
Aidarex Pharmaceuticals is recalling specific lots of Enalapril Maleate 5mg tablets distributed in Florida due to out-of-specification 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 agency classified this as an FDA Class III recall, which is defined as unlikely to cause adverse health consequences. The rubric indicates that Class III recalls are typically scored as 1 or 2; a score of 2 is appropriate for a pharmaceutical impurity issue that does not meet the criteria for High severity (such as high-risk pathogens or known injuries).
Plain-English summary
Aidarex Pharmaceuticals LLC is recalling 12 bottles of Enalapril Maleate Tablets, USP, 5mg, 90-count bottles. The product is prescription-only and was manufactured by Wockhardt Ltd. in India and packaged by Aidarex Pharmaceuticals. The specific NDC number is 33261-0693-90.
The recall was initiated because the manufacturer identified out-of-specification results for a related compound, which constitutes a failure of impurities and degradation specifications. The affected lots are 55097-2 and 56085-1, with an expiration date of 11/30/2018.
The product was distributed in Florida. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled description.
The recalled product
- Product
- ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmaceuticals; NDC 33261-0693-90.
- Manufacturer
- Aidarex Pharmaceuticals LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 12
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 #: 55097-2
- 56085-1
- Exp 11/30/2018
Distribution
Distributed in 1 state:
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