🔍 RecallPedia

Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90

Class I - Dangerous
💊 Drugs Recalled: June 27, 2018 Aidarex Pharmaceuticals Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Aidarex Pharmaceuticals LLC
Reason for Recall:
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90

Product Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0991-2018

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