Class I โ€” Serious Health Hazard

Serious health hazard โ€” there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Warfarin Sodium Tablets Recalled by Zydus Pharmaceuticals USA Inc Due to Failed Tablet/Capsule Specifications: A product complaint was received...

Date: May 13, 2013
Company: Zydus Pharmaceuticals USA 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 Zydus Pharmaceuticals USA Inc directly.

Affected Products

Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-053-10

Quantity: 960 Bottles

Why Was This Recalled?

Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Zydus Pharmaceuticals USA Inc

Zydus Pharmaceuticals USA Inc has 41 total recalls tracked by RecallDetector.

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