FDAClass IINovember 23, 2022

Carvedilol Tablets recall

Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05

Why was Carvedilol Tablets recalled?

Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 3150116, Exp 2/2025

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
Recalling firm
Viatris Inc
Quantity
2,794 bottles
Distribution
Nationwide in the USA
Recall date
November 23, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls