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.

Nortriptyline HCl Capsules Recalled by Taro Pharmaceuticals U.S.A., Inc. Due to CGMP deviations.

Date: January 8, 2021
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

Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 NDC 51672-4001-1

Quantity: 44,256 bottles

Why Was This Recalled?

CGMP deviations.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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