Carvedilol Tablets 25 mg Recalled for Weight and Thickness Specification Failures
Viatris Inc is recalling 2,794 bottles of Carvedilol Tablets 25 mg nationwide because the tablets exceed FDA specifications for weight and thickness. Patients should verify their lot number and contact their pharmacist if affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a manufacturing defect affecting tablet specifications in a prescription cardiovascular medication. Although no illnesses or injuries have been reported, specification failures in tablets that exceed weight and thickness parameters create a risk of improper drug delivery.
Plain-English summary
Viatris Inc is recalling 2,794 bottles of Carvedilol Tablets, USP, 25 mg (NDC 0378-3634-05) nationwide in the United States because the tablets exceed specifications for weight and thickness.
Carvedilol is a prescription medication used to treat high blood pressure and heart failure. The affected lot number is 3150116, which expires in February 2025.
Patients taking this medication should not stop treatment without consulting their doctor or pharmacist. If you have Carvedilol Tablets, check the lot number and expiration date on your bottle. If your tablets are from lot 3150116, contact your pharmacist or healthcare provider to verify if your supply is affected and to arrange an alternative supply.
The recalled product
- Product
- Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05
- Manufacturer
- Viatris Inc
- Category
- Drug — Cardiovascular
- Hazard
- tablet-specification-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 3150116
- Exp 2/2025
Distribution
Distributed nationwide across the United States.
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