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 25 mg Tablet Recalled by RemedyRepack Inc. Due to CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC...

Date: January 24, 2025
Company: RemedyRepack 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 RemedyRepack Inc. directly.

Affected Products

Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00.

Quantity: 247 blister packs

Why Was This Recalled?

CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.

Where Was This Sold?

This product was distributed to 1 state: FL

Affected (1 state)Not affected

About RemedyRepack Inc.

RemedyRepack Inc. has 60 total recalls tracked by RecallDetector.

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