US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Apr 24, 2024 (2 years ago)

Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Discoloration: Dotted and yellow spots on tablets

What was recalled

Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.

Recalling firm
Aurobindo Pharma USA Inc.
NDC code
13107-282-01
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0491-2024

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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