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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot #: 3090167, Exp. October 2019
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Mylan Pharmaceuticals Inc.
Reason for Recall:
Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Lot #: 3090167, Exp. October 2019

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0506-2019

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