Agency classClass IIIOur severity:Moderate FDA (Drugs)·D-0991-2018·Announced 2018-08-01

Aidarex Recalls Enalapril Maleate Due to Out-of-Specification Degradation Product

Aidarex Pharmaceuticals is recalling specific lots of Enalapril Maleate 5mg due to out-of-specification results for a degradation product during commercial stability.

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 FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The issue is a stability failure (out-of-specification degradation product) without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Aidarex Pharmaceuticals LLC is recalling 61 bottles of Enalapril Maleate, USP 5mg, 90-count, prescription-only medication. The product was manufactured by Wockhardt Ltd. in India and packaged by Aidarex Pharmaceuticals. The recall involves specific lots with expiration dates ranging from January 2018 to May 2019.

The recall was initiated because of out-of-specification results for the Enalapril Diketopiperazine degradation product detected during commercial stability testing. This indicates that the chemical stability of the medication did not meet required standards for the affected lots.

The affected medication was distributed nationwide in the USA. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the medication matches the recalled lots, it should be returned to the pharmacy or supplier for replacement or refund.

The recalled product

Product: Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90
Manufacturer: Aidarex Pharmaceuticals LLC
Category: Drug — Prescription Medication
Hazard: stability-failure
degradation-product

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 (19)

Lots: 51904-1
EXP: 01/31/2018
51904-4
52885-1
EXP: 03/31/2018
52885-3
EXP: 04/30/2018
52885-4
EXP: 05/28/2018
53840-2
EXP: 5/28/2018
53840-3
EXP:6/30/2018
53840-4
EXP:8/31/2018
56665-1
EXP: 01/31/2019
58596-1
EXP: 05/28/2019.

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 →

Same manufacturer · Aidarex Pharmaceuticals LLC

See all →

Low
Aidarex Recalls Enalapril Maleate Due to Out-of-Specification Degradation Product
FDA (Drugs) · 2018-08-01
Low
Aidarex Recalls Enalapril Maleate 2.5mg Due to Stability Issues
FDA (Drugs) · 2018-08-01
Low
Aidarex Recalls Ferrous Sulfate Tablets Due to Foreign Material Presence
FDA (Drugs) · 2018-05-23
Moderate
Aidarex Recalls Enalapril Maleate Tablets Due to Impurity Failures
FDA (Drugs) · 2017-11-01
Low
Aidarex Recalls Phentermine Capsules Due to Impurity Test Failures
FDA (Drugs) · 2017-09-20

Same hazard · stability failure