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.

Clozapine Tablets USP tablet Recalled by Aurobindo Pharma USA Inc. Due to Presence of foreign tablet: Consumer complaint of Clozapine...

Date: June 12, 2020
Company: Aurobindo Pharma 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 Aurobindo Pharma USA Inc. directly.

Affected Products

Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-846-05

Quantity: 1440 bottles

Why Was This Recalled?

Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Aurobindo Pharma USA Inc.

Aurobindo Pharma USA Inc. has 47 total recalls tracked by RecallDetector.

Related Recalls

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