US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jun 3, 2022 (4 years ago)

Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun…

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

Why it was recalled

Failed Tablet/Capsule Specification; oversized tablet found in a bottle

What was recalled

Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd. Mumbai, India, Dist. by: Sun Pharmaceutical Industries In., Cranbury, NJ 08512, NDC 57664-783-68, packaged in bottles.

Recalling firm
Sun Pharmaceutical Industries INC
NDC code
57664-783-68
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1155-2022

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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