Class III — Low Risk

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

Diltiazem HCl Extended-Release Capsules Recalled by Mylan Pharmaceuticals Inc. Due to Failed Impurities/Degradation Specifications: High out of specification results...

Date: February 13, 2019
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

Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505

Quantity: 8,159 bottles

Why Was This Recalled?

Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing

Where Was This Sold?

Throughout the 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