Medications & Supplements/Prescription Drugs

Wockhardt Usa Inc.: Enalapril Maleate Tablets Recalled for Impurity Specifications

Agency Publication Date: October 26, 2017

Summary

Wockhardt USA is recalling 5,050 bottles of Enalapril Maleate (5mg), a prescription medication used to treat high blood pressure. The recall was initiated because testing showed the presence of an impurity or degradation product that exceeded safety specifications. This recall affects the 1,000-count bottles distributed nationwide in the United States.

Risk

The product contains a related compound that failed degradation specifications, which may affect the purity and quality of the medication. Taking a drug with out-of-specification impurities can lead to unexpected side effects or reduced effectiveness over time.

What You Should Do

Check your medication bottle for Enalapril Maleate tablets, USP, 5mg in 1,000-count bottles.
Verify if your bottle belongs to Lot # DR10635 or DR10636, both with an expiration date of 05/2019.
Check the package for NDC number 64679-924-03 to confirm it is the affected product.
If you have an affected bottle, contact your healthcare provider or pharmacist for guidance before you stop taking your medication.
Return any unused product to your pharmacy for a refund and contact Wockhardt USA for further instructions.
For general questions about the recall, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Return unused medication for a 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 (1000-count bottles)

Model:

NDC: 64679-924-03

Lot Numbers:

DR10635 (Exp 05/2019)

DR10636 (Exp 05/2019)

Date Ranges: Expiration Date 05/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 77951

Status: Resolved

Manufacturer: Wockhardt Usa Inc.

Sold By: pharmacies; healthcare providers

Manufactured In: India, United States

Units Affected: 5050 bottles

Distributed To: Nationwide

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

Check your medication bottle for Enalapril Maleate tablets, USP, 5mg in 1,000-count bottles.

Verify if your bottle belongs to Lot # DR10635 or DR10636, both with an expiration date of 05/2019.

Check the package for NDC number 64679-924-03 to confirm it is the affected product.

If you have an affected bottle, contact your healthcare provider or pharmacist for guidance before you stop taking your medication.

Return any unused product to your pharmacy for a refund and contact Wockhardt USA for further instructions.

For general questions about the recall, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.