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Class II · ModerateRecall completed

Clozapine

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: CZSC20003-A, Exp 1/2022
Where it was soldU.S.A. Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in India foreign manufacturer
Brand nameCLOZAPINE
Generic nameCLOZAPINE
Active ingredient(s)CLOZAPINE
Distributed by / forAurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520
NDC65862-846-05
Show the full FDA record
Full product labelClozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-846-05
Recalling firmAurobindo Pharma USA Inc.
DistributionU.S.A. Nationwide
Quantity1440 bottles
Recall initiated2020-06-12
Report date2020-07-01
Recall completed2022-12-21
Recall numberD-1370-2020
ClassificationClass II
FDA statusTerminated
Origin on fileEast Windsor NJ United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.