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Class II · ModerateActive recall

Chlorpromazine Hydrochloride

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

Does this affect you?
Check your lot numberLot #: Z400069, Exp.: 12/31/2025
Where it was soldNationwide within U.S - MS, AL, TN, VT, OH, ND, MN, WI, SC, AR, FL, IN, LA, NJ, AZ, TX, KY and PA
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

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

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 byZydus Lifesciences Ltd., Baddi, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534 foreign manufacturer
Brand nameCHLORPROMAZINE HYDROCHLORIDE
Generic nameCHLORPROMAZINE HYDROCHLORIDE
Active ingredient(s)CHLORPROMAZINE HYDROCHLORIDE
Distributed by / forZydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534
NDC70710-1129-1
Show the full FDA record
Full product labelchlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1129-1
Recalling firmZydus Pharmaceuticals (USA) Inc
DistributionNationwide within U.S - MS, AL, TN, VT, OH, ND, MN, WI, SC, AR, FL, IN, LA, NJ, AZ, TX, KY and PA
Quantity3144 bottles, pack size: 100's Count
Recall initiated2025-04-03
Report date2025-04-16
Recall completed—
Recall numberD-0361-2025
ClassificationClass II
FDA statusOngoing
Origin on filePennington 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.