Aidarex Recalls Enalapril Maleate 2.5mg Due to Stability Issues
Aidarex Pharmaceuticals is recalling 11 bottles of Enalapril Maleate 2.5mg because out-of-specification degradation products were found during stability testing.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor quality issues.
Plain-English summary
Aidarex Pharmaceuticals LLC is recalling 11 bottles of Enalapril Maleate, USP 2.5mg, 90-count bottles. The product is prescription-only and was distributed nationwide in the USA. The specific lots affected are 56698-1 (expiration date 1/31/2019) and 56698-2 (expiration date 4/30/2019).
The recall was initiated because out-of-specification results for the Enalapril Diketopiperazine degradation product were observed during commercial stability testing. This indicates that the medication may not meet quality standards over time.
Consumers who have this medication should contact their healthcare provider or pharmacist for guidance on how to proceed. The FDA has classified this recall as Class III, which means it is unlikely to cause adverse health consequences.
The recalled product
- Product
- Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90
- Manufacturer
- Aidarex Pharmaceuticals LLC
- Category
- Drug — Prescription Medication
- Hazard
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 (4)
- Lots: 56698-1
- EXP 1/31/2019
- 56698-2
- EXP 4/30/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Aidarex Pharmaceuticals LLC 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.
See all 3 products in this recall →Related recalls
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