RecallRadar

FDA Drug recall D-1155-2022

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

On 2022-06-29 the FDA classified a Class II recall of Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd by Sun Pharmaceutical Industries, citing failed Tablet/Capsule Specification; oversized tablet found in a bottle.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1155-2022
ClassificationClass II
Statusterminated
Initiated2022-06-03
Published2022-06-29
Last updated2026-09-13 11:52 UTC
CompanySun Pharmaceutical Industries
DistributionUS

Product

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.

Reason

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

Identifiers

code_infoLot #: MHC1430A, Exp. Date 09/2023

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1155-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.