Safety Alert: Class II: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
healthClass IIRecalled on Sep 17, 2025
Chlorpromazine Hydrochloride Tablets, USP, 100 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-0636-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- Lot #: Z305079, Z305080, Exp Date 30-09-25; Z305454, Z305455, Z305457, Z400492, Z400493, Z400494, Exp Date 31-12-25; Z401158, Z401725, Z401726, Exp. Date 28-02-26; Z404118, Z404119, Z404120, Exp Date 30-06-26; Z405648, Exp Date 30-09-26
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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.