Medications & Supplements/Prescription Drugs

Viatris Carvedilol Tablets Recalled for Weight and Thickness Defects

Agency Publication Date: November 16, 2022

Summary

Viatris Inc has recalled 2,794 bottles of Carvedilol (generic Coreg) 25 mg tablets, a prescription medication used to treat heart failure and high blood pressure. The recall was issued because the tablets were found to exceed the required specifications for weight and thickness. No injuries or adverse incidents have been reported in connection with this recall to date.

Risk

Tablets that are heavier or thicker than specified may contain an inconsistent dosage of the medication. This could potentially lead to patients receiving more or less of the prescribed drug than intended, which may interfere with the management of serious heart conditions.

What You Should Do

This recall affects 500-count bottles of Carvedilol Tablets, USP, 25 mg, manufactured for Mylan Pharmaceuticals Inc. (NDC 0378-3634-05).
Check your medication bottle for lot number 3150116 with an expiration date of February 2025 (2/2025).
If you have health concerns or are unsure about your medication, contact your healthcare provider or pharmacist immediately. Return any unused product from the affected lot to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Carvedilol Tablets, USP, 25 mg (500-count bottles)

Variants: 25 mg, 500-count

Lot Numbers:

3150116 (Exp 2/2025)

NDC:

0378-3634-05

Manufactured by Mylan Pharmaceuticals Inc. in Morgantown, WV 36505 or India.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91038

Status: Resolved

Manufacturer: Viatris Inc

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 2,794 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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

This recall affects 500-count bottles of Carvedilol Tablets, USP, 25 mg, manufactured for Mylan Pharmaceuticals Inc. (NDC 0378-3634-05).

Check your medication bottle for lot number 3150116 with an expiration date of February 2025 (2/2025).

If you have health concerns or are unsure about your medication, contact your healthcare provider or pharmacist immediately. Return any unused product from the affected lot to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.