RecallRadar

FDA Drug recall D-0096-2018

Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICALS IND, LTD, Jerusalem Israel, Manu…

On 2017-12-06 the FDA classified a Class II recall of Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICALS IND, LTD, Jerusalem Israel, Manu… by Teva Pharmaceuticals Usa, citing failed Tablet/Capsule Specifications; potential presence of broken tablets.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0096-2018
ClassificationClass II
Statusterminated
Initiated2017-11-09
Published2017-12-06
Last updated2026-09-13 11:51 UTC
CompanyTeva Pharmaceuticals Usa
DistributionUS

Product

Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICALS IND, LTD, Jerusalem Israel, Manufactured For: TEVA PHARMACEUTICALS USA, North Wales, PA, NDC 00093-7772-05

Reason

Failed Tablet/Capsule Specifications; potential presence of broken tablets.

Identifiers

code_infoLot # 39C192, exp 06/2019

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0096-2018%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.