Medications & Supplements/Prescription Drugs

Amerisource Health Services: Enalapril Maleate Tablets Recalled for Failed Stability Specifications

Agency Publication Date: November 10, 2017

Summary

Amerisource Health Services is recalling approximately 93,600 tablets of Enalapril Maleate (5 mg), a prescription medication used to treat high blood pressure. This recall was initiated because the tablets failed stability specifications, meaning the drug may not maintain its required strength or quality through its expiration date. Using a medication that has lost its potency can lead to ineffective treatment of blood pressure conditions. The affected products were distributed nationwide in the USA and Puerto Rico.

Risk

The tablets failed to meet stability standards, which can result in the medication losing its effectiveness before the labeled expiration date. For patients relying on this drug to manage hypertension, reduced potency could lead to uncontrolled high blood pressure and related health complications.

What You Should Do

Check your medication packaging for Enalapril Maleate Tablets, USP, 5 mg, specifically the 100-tablet packs (10 x 10) distributed by American Health Packaging.
Verify if your medication is part of the recall by looking for Lot Number 167194 with an expiration date of 12/31/2018 and NDC 68084-390-01.
Contact your healthcare provider or pharmacist immediately to discuss a replacement prescription if you identify that your medication is part of this recall.
Return any unused tablets from the affected lot to your pharmacy for a refund and further instructions.
Contact Amerisource Health Services or American Health Packaging for more information regarding this voluntary recall.
For additional questions or to report a side effect, 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

Pharmacy refund and healthcare consultation

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, 5 mg (100 Tablets)

Model:

NDC: 68084-390-01

Recall #: D-0074-2018

Lot Numbers:

167194 (Exp. 12/31/2018)

Date Ranges: Expiration Date: 12/31/2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78118

Status: Resolved

Manufacturer: Amerisource Health Services

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 93,600 tablets

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 packaging for Enalapril Maleate Tablets, USP, 5 mg, specifically the 100-tablet packs (10 x 10) distributed by American Health Packaging.

Verify if your medication is part of the recall by looking for Lot Number 167194 with an expiration date of 12/31/2018 and NDC 68084-390-01.

Contact your healthcare provider or pharmacist immediately to discuss a replacement prescription if you identify that your medication is part of this recall.

Return any unused tablets from the affected lot to your pharmacy for a refund and further instructions.

Contact Amerisource Health Services or American Health Packaging for more information regarding this voluntary recall.

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