HIGH

Zydus Pharmaceuticals Recalls Chlorpromazine Tablets Due to High Contaminant Levels

Zydus Pharmaceuticals recalled Chlorpromazine Hydrochloride Tablets on September 3, 2025. The recall affects 25 mg tablets due to high levels of N-Nitroso Desmethyl Chlorpromazine. Consumers must stop using the product immediately.

Quick Facts at a Glance

Recall Date
September 3, 2025
Hazard Level
HIGH
Brands
Chlorpromazine Hydrochloride, Zydus Pharmaceuticals
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

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 Chlorpromazine Hydrochloride Tablets, USP, come in 100-count bottles. The affected lot numbers include Z305060, Z305061, Z306323, Z401153, Z403015, Z403016, and Z405591. They were distributed nationwide in the USA.

The Hazard

The recall stems from CGMP deviations due to the presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit. This chemical is a potential carcinogen, posing serious health risks.

Reported Incidents

No injuries or incidents have been reported as a result of this recall. However, the potential health risks warrant immediate action.

What to Do

Stop using the product immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for guidance on what to do next.

Contact Information

For more information, call Zydus Pharmaceuticals at 1-800-XXX-XXXX or visit their website at www.zydus.com.

Key Facts

  • Recalled product: Chlorpromazine Hydrochloride Tablets, USP, 25 mg
  • Recall date: September 3, 2025
  • Class II recall due to CGMP violations
  • Immediate cessation of use recommended
  • Distributed nationwide in the USA

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
Z305060
Z305061
Z306323
Z401153
Z403015
+2 more
UPC Codes
70710-1129
70710-1130
70710-1131
+12 more
Affected States
ALL
Report Date
September 17, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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