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Class II · ModerateActive recall

Clorazepate Dipotassium

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

Does this affect you?
Check your lot numberLot #s: a) CZB124001B, CZB124002B, CZB124003B, Exp. 12/31/2025; b) CZB124001A, CZB124003A, Exp. 12/31/2025.
Where it was soldNationwide in the USA
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

Discoloration: Dotted and yellow spots on tablets

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 nameCLORAZEPATE DIPOTASSIUM
Generic nameCLORAZEPATE DIPOTASSIUM
Active ingredient(s)CLORAZEPATE DIPOTASSIUM
Distributed by / forAurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520
NDC13107-283-01
Show the full FDA record
Full product labelClorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
Recalling firmAurobindo Pharma USA Inc.
DistributionNationwide in the USA
Quantity6909 bottles
Recall initiated2024-04-24
Report date2024-05-15
Recall completed—
Recall numberD-0492-2024
ClassificationClass II
FDA statusOngoing
Origin on fileEast Windsor NJ United States

Related

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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.