Medications & Supplements/Prescription Drugs

Aidarex Pharmaceuticals LLC: Enalapril Maleate Tablets Recalled for Impurity and Degradation Issues

Agency Publication Date: October 26, 2017

Summary

Aidarex Pharmaceuticals LLC has recalled 12 bottles of Enalapril Maleate (5mg), a prescription medication used to treat high blood pressure. This recall was initiated because the tablets failed testing for impurities and degradation, which means the medication may contain compounds that do not meet safety and quality standards. The affected products were manufactured by Wockhardt Ltd. in India and repackaged by Aidarex for distribution in Florida.

Risk

The presence of impurities or degradation products above the approved limits may result in decreased effectiveness of the medication or exposure to unintended chemical compounds, potentially impacting the health of patients relying on this blood pressure treatment.

What You Should Do

Identify your medication by checking the label for ENALAPRIL MALEATE Tablets, USP, 5MG in 90-count bottles with NDC 33261-0693-90.
Check the bottle for Lot numbers 55097-2 or 56085-1 with an expiration date of 11/30/2018.
Contact your healthcare provider or pharmacist immediately to discuss an alternative treatment and to determine if your specific medication is part of the recall.
Return any unused portions of the affected medication to the pharmacy where you purchased it to receive a refund and ensure the product is safely handled.
Contact Aidarex Pharmaceuticals LLC for further instructions regarding this recall.
For additional questions or to report side effects, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Consult healthcare professionals and return product for refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: ENALAPRIL MALEATE Tablets, USP, 5MG (90-count bottle)

Model:

NDC 33261-0693-90

Lot Numbers:

55097-2 (Exp 11/30/2018)

56085-1 (Exp 11/30/2018)

Date Ranges: Expiration Date 11/30/2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78106

Status: Resolved

Manufacturer: Aidarex Pharmaceuticals LLC

Sold By: pharmacies

Manufactured In: India, United States

Units Affected: 12 bottles

Distributed To: Florida

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify your medication by checking the label for ENALAPRIL MALEATE Tablets, USP, 5MG in 90-count bottles with NDC 33261-0693-90.

Check the bottle for Lot numbers 55097-2 or 56085-1 with an expiration date of 11/30/2018.

Contact your healthcare provider or pharmacist immediately to discuss an alternative treatment and to determine if your specific medication is part of the recall.

Return any unused portions of the affected medication to the pharmacy where you purchased it to receive a refund and ensure the product is safely handled.

Contact Aidarex Pharmaceuticals LLC for further instructions regarding this recall.

For additional questions or to report side effects, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.