Amerisource Health Services Enalapril Maleate Tablets Recall

Why it was recalled

Failed Stability Specifications

Product description

Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-390-01

Lot numbers, UPCs & expiration codes

Lot #:167194; Exp. 12/31/2018

Where it was sold

Nationwide USA and Puerto Rico

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0074-2018
Classification: Class III
Status: Terminated
Recall initiated: Aug 29, 2017
FDA report date: Nov 22, 2017
Quantity: 93,600 tablets
Recall type: Voluntary: Firm initiated
Recalling firm: Amerisource Health Services

Original FDA data

Every field from FDA enforcement report D-0074-2018, exactly as published.

Show all FDA fields

City: Columbus
State: OH
Status: Terminated
Country: United States
Event ID: 78118
Address: 2550 John Glenn Ave Ste A
Code information: Lot #:167194; Exp. 12/31/2018
Postal code: 43217-1188
Report date: Nov 22, 2017
Product type: Drugs
Recall number: D-0074-2018
Classification: Class III
Recalling firm: Amerisource Health Services
Product quantity: 93,600 tablets
Termination date: Aug 21, 2019
Reason for recall: Failed Stability Specifications
Voluntary / mandated: Voluntary: Firm initiated
Product description: Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-390-01
Distribution pattern: Nationwide USA and Puerto Rico
Recall initiation date: Aug 29, 2017
Initial firm notification: Letter
Center classification date: Nov 10, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0074-2018, published Nov 22, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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