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.

Clorazepate Dipotassium Tablets Recalled by Aurobindo Pharma USA Inc. Due to Discoloration: Dotted and yellow spots on tablets

Date: April 24, 2024
Company: Aurobindo Pharma USA Inc.
Status: Ongoing
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

Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.

Quantity: 6909 bottles

Why Was This Recalled?

Discoloration: Dotted and yellow spots on tablets

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.

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