Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Enalapril Maleate Tablets USP Recalled by AMERICAN HEALTH PACKAGING Due to Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril...

Date: June 25, 2018
Company: AMERICAN HEALTH PACKAGING
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact AMERICAN HEALTH PACKAGING directly.

Affected Products

Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-390-01 Carton [68084-390-11 - Unit Dose]

Quantity: 1285 cartons (cartons of 100 individual unit doses)

Why Was This Recalled?

Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant

Where Was This Sold?

Lot#166023 products distributed from 12/29/16 to 1/19/17 and Lot#168467 distributed from 4/6/17 to 9/11/17. Distributors are the wholesalers who received the product; others are the Corporate Offices for those wholesalers.

About AMERICAN HEALTH PACKAGING

AMERICAN HEALTH PACKAGING has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report