HIGH

Zydus Lifesciences Recalls Chlorpromazine Tablets Due to Hazard

Zydus Lifesciences recalled Chlorpromazine Hydrochloride Tablets on September 3, 2025. The tablets contain N-Nitroso Desmethyl Chlorpromazine above safe intake levels. Consumers must stop using the product immediately and consult healthcare providers.

Hazard Information

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

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for guidance. Notification method: N/A

Product Details

The recalled product is Chlorpromazine Hydrochloride Tablets, USP, 50 mg, sold in 100-count bottles. The affected lot numbers are Z306326 and Z401155, with expiration dates of November 30, 2025, and February 28, 2026, respectively.

The Hazard

The product contains N-Nitroso Desmethyl Chlorpromazine above the acceptable intake limit. This chemical is a potential carcinogen, posing serious health risks.

Reported Incidents

No specific incidents or injuries related to this recall have been reported. The recall was initiated due to CGMP deviations.

What to Do

Stop using the recalled tablets immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for further guidance.

Contact Information

For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0635-2025 or contact Zydus Pharmaceuticals.

Key Facts

  • Manufacturer: Zydus Lifesciences Ltd.
  • Distributed by: Northstar Rx LLC
  • Recall Date: September 3, 2025
  • Class II recall due to health risks
  • Stop using the product immediately
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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeChlorpromazine Hydrochloride Tablets
Sold At
Multiple Retailers

Product Details

Model Numbers
Z306326
Z401155
UPC Codes
16714-047
16714-048
16714-049
+7 more
Affected States
ALL
Report Date
September 17, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE
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