Medications & Supplements/Prescription Drugs

Mylan Pharmaceuticals Inc.: Diltiazem HCl Extended-Release Capsules Recalled for Failed Impurity Tests

Agency Publication Date: February 15, 2019

Summary

Mylan Pharmaceuticals Inc. has recalled 8,159 bottles of Diltiazem HCl Extended-Release Capsules (180mg), a prescription medication used to treat high blood pressure and chest pain. This recall was initiated after routine stability testing found that the capsules exceeded specifications for impurities and degradation, which means the drug may not meet quality standards over time. If you are taking this medication, do not stop your treatment without first speaking to a medical professional, as stopping blood pressure medication abruptly can be dangerous.

Risk

The product failed to meet stability specifications for impurities and degradation during routine testing, which could potentially affect the effectiveness or safety of the medication over its shelf life.

What You Should Do

Check your prescription bottle to see if it is Diltiazem HCl Extended-Release Capsules, USP 180mg, in either 100-count or 500-count bottles.
Identify if your bottle is part of the affected lot by looking for Lot #: 3090167 with an expiration date of October 2019 (Exp. October 2019).
Verify the National Drug Code (NDC) on the label: NDC 0378-5280-01 for 100-count bottles or NDC 0378-5280-05 for 500-count bottles.
If your medication matches this lot and NDC, contact your healthcare provider or pharmacist immediately for guidance on obtaining a replacement and to discuss your ongoing treatment.
Return any unused capsules from the affected lot to your pharmacy for a refund and further instructions from the manufacturer.
For further questions regarding this recall, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare consultation and pharmacy return

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Diltiazem HCl Extended-Release Capsules, USP 180mg (100-count bottle)

Model:

NDC 0378-5280-01

Recall #: D-0506-2019

Lot Numbers:

3090167 (Exp. October 2019)

Date Ranges: Expiration October 2019

Product: Diltiazem HCl Extended-Release Capsules, USP 180mg (500-count bottle)

Model:

NDC 0378-5280-05

Recall #: D-0506-2019

Lot Numbers:

3090167 (Exp. October 2019)

Date Ranges: Expiration October 2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82086

Status: Resolved

Manufacturer: Mylan Pharmaceuticals Inc.

Manufactured In: United States

Units Affected: 8,159 bottles

Distributed To: Nationwide

Agency Last Updated: March 6, 2019

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your prescription bottle to see if it is Diltiazem HCl Extended-Release Capsules, USP 180mg, in either 100-count or 500-count bottles.

Identify if your bottle is part of the affected lot by looking for Lot #: 3090167 with an expiration date of October 2019 (Exp. October 2019).

Verify the National Drug Code (NDC) on the label: NDC 0378-5280-01 for 100-count bottles or NDC 0378-5280-05 for 500-count bottles.

If your medication matches this lot and NDC, contact your healthcare provider or pharmacist immediately for guidance on obtaining a replacement and to discuss your ongoing treatment.

Return any unused capsules from the affected lot to your pharmacy for a refund and further instructions from the manufacturer.

For further questions regarding this recall, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Diltiazem HCl Extended-Release Capsules, USP 180mg (100-count bottle)

Model:

NDC 0378-5280-01

Recall #: D-0506-2019

Lot Numbers:

3090167 (Exp. October 2019)

Date Ranges: Expiration October 2019

Product: Diltiazem HCl Extended-Release Capsules, USP 180mg (500-count bottle)

Model:

NDC 0378-5280-05

Recall #: D-0506-2019

Lot Numbers:

3090167 (Exp. October 2019)

Date Ranges: Expiration October 2019