Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Carbamazepine Tablets USP Recalled by Taro Pharmaceuticals U.S.A., Inc. Due to Marketed without an Approved NDA/ANDA: One lot was...

Date: October 21, 2014
Company: Taro Pharmaceuticals U.S.A., 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 Taro Pharmaceuticals U.S.A., Inc. directly.

Affected Products

Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 26110 Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4005-3.

Quantity: 1,966 bottles

Why Was This Recalled?

Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing site for the Carbamazepine API final intermediate was pending approval.

Where Was This Sold?

This product was distributed to 3 states: IL, LA, OH

Affected (3 states)Not affected

About Taro Pharmaceuticals U.S.A., Inc.

Taro Pharmaceuticals U.S.A., Inc. has 36 total recalls tracked by RecallDetector.

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