The Recall Desk
ModerateFDA (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.

What this means for you

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

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 →

Related recalls

Same manufacturer · Aidarex Pharmaceuticals LLC

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Same hazard · stability failure

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