Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Amlodipine and Benazapril HCL Capsules Recalled by Mylan Pharmaceuticals Inc. Due to cGMP Deviations; cleaning processes for equipment used to...

Date: April 24, 2018
Company: Mylan Pharmaceuticals Inc.
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 Mylan Pharmaceuticals Inc. directly.

Affected Products

Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01

Quantity: 12,924 bottles

Why Was This Recalled?

cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure

Where Was This Sold?

Product was distributed throughout United States

About Mylan Pharmaceuticals Inc.

Mylan Pharmaceuticals Inc. has 71 total recalls tracked by RecallDetector.

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