Medications & Supplements/Prescription Drugs

Carvedilol 6.25 mg Tablets Recalled for Failed Impurity Specifications

Agency Publication Date: December 1, 2021

Summary

Aurobindo Pharma USA Inc. is recalling 7,296 bottles of Carvedilol (carvedilol) 6.25 mg tablets, a medication used to treat high blood pressure and heart failure. The recall was initiated because the tablets failed to meet required specifications for impurities and degradation during testing. No incidents or injuries have been reported in connection with this recall.

Risk

The product failed to meet quality standards for impurities, meaning the medication may contain higher levels of degraded components than allowed, potentially impacting the purity and quality of the drug over time.

What You Should Do

This recall affects Carvedilol Tablets, USP, 6.25 mg, sold in 500-count bottles (NDC 65862-143-05) distributed by Aurobindo Pharma USA Inc.
Check the label on your prescription bottle for batch number QG0619030-A and an expiration date of 11/2022.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Aurobindo Pharma USA Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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, 6.25 mg (500 Tablets bottle)

Variants: 6.25 mg, Tablet

Lot Numbers:

QG0619030-A (Exp 11/2022)

NDC:

65862-143-05

Rx Only; Recall #: D-0263-2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89045

Status: Resolved

Manufacturer: Aurobindo Pharma USA Inc.

Sold By: pharmacies

Manufactured In: India, United States

Units Affected: 7296 containers

Distributed To: Nationwide

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 Carvedilol Tablets, USP, 6.25 mg, sold in 500-count bottles (NDC 65862-143-05) distributed by Aurobindo Pharma USA Inc.

Check the label on your prescription bottle for batch number QG0619030-A and an expiration date of 11/2022.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Aurobindo Pharma USA Inc. for further instructions.

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