Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Carvedilol Tablets Recalled by Mylan Pharmaceuticals Inc. Due to Failed Tablet/Capsule Specifications: Product exceeds specification for tablet...

Date: January 16, 2013
Company: Mylan Pharmaceuticals Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Mylan Pharmaceuticals Inc. directly.

Affected Products

Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-3633-05, UPC 3 0378-3633-05 3.

Quantity: 11,580 bottles

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Mylan Pharmaceuticals Inc.

Mylan Pharmaceuticals Inc. has 71 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report