healthClass IIRecalled on Sep 17, 2025

Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi

🔢 N/A

Sold At: Zydus Pharmaceuticals (USA) Inc(Nationwide in the USA)

Recall #: FDA-DRUG-D-0638-2025

Source: FDA-ENFORCEMENT

Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi

Product Identification

Lot/Batch Codes:
Lot #: Z305083, Z305084, Z305468, Z305469, Z305470, Exp Date 30-09-25; Z401163, Z401165, Exp Date 28-02-26; Z402217, Z402218, Exp Date 31-03-26; Z405518, Z405520, Exp Date 31-08-26; Z406235, Exp Date 31-10-26

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Summary

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

What to do next

  • 1Stop using this product - may cause temporary or medically reversible health problems
  • 2Check with retailer or manufacturer for recall status and remedy options
  • 3Contact Zydus Pharmaceuticals (USA) Inc for return or refund information
  • 4Visit the official FDA recall page for complete details

Summaries only; always follow the official notice.