HIGH

Zydus Lifesciences Chlorpromazine Tablets Recalled for N-Nitroso Desmethyl Chlorpromazine Beyond FDA

Chlorpromazine Hydrochloride Tablets, 200 mg, 100-count bottle, manufactured by Zydus Lifesciences Ltd. and distributed by Northstar Rx LLC, are under recall nationwide in the United States. The CGMP deviation involves elevated levels of N-Nitroso Desmethyl Chlorpromazine. Consumers should stop use and contact their healthcare provider.

Quick Facts at a Glance

Recall Date
September 3, 2025
Hazard Level
HIGH
Brands
Zydus Lifesciences, Northstar Rx LLC
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL, PREGNANT

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

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About This Product

Chlorpromazine is an antipsychotic used to treat schizophrenia and bipolar disorder. It is a prescription medication distributed nationwide in the United States.

Why This Is Dangerous

N-Nitroso Desmethyl Chlorpromazine above acceptable intake limits can raise health concerns with long-term exposure.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

No injuries reported in the recall. Consumers should stop use and seek guidance from healthcare providers.

Practical Guidance

How to identify if yours is affected

  1. Identify NDC 16714-051-01 on bottle label
  2. Verify lot numbers on packaging if available
  3. Check FDA recall notice for affected lots

Where to find product info

NDC label, pharmacy packaging, and FDA recall page

What timeline to expect

Remedy process and refunds/replacements typically guided by manufacturer and FDA timelines

If the manufacturer is unresponsive

  • Document all contacts and responses
  • Escalate to FDA recall hotline if needed
  • Consider legal counsel if unaddressed for serious health concerns

How to prevent similar issues

  • Verify NDC and lot numbers when receiving prescription medications
  • Ask pharmacists about CGMP compliance and lot-specific recalls
  • Check FDA recall database routinely

Documentation advice

Retain recall notices, prescription records, and all correspondence with manufacturers and pharmacies

Product Details

Brand: Zydus Lifesciences; Distributor: Northstar Rx LLC; Product: Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle; NDC: 16714-051-01; Manufactured by: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC, Memphis, TN 38141; Sold nationwide in the USA; Status: Active recall as of 2025-09-03; Models: Z305085, Z401166, Z401167.

Reported Incidents

No specific injuries or incidents are detailed in the recall notice.

Key Facts

  • NDC 16714-051-01
  • Manufactured for Northstar Rx LLC, Memphis, TN 38141
  • Active recall date: 2025-09-03
  • Model numbers: Z305085, Z401166, Z401167
  • CGMP deviations: elevated N-Nitroso Desmethyl Chlorpromazine
  • Nationwide distribution in the USA

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANT
Injury Types
POISONINGLACERATIONELECTRICAL

Product Details

Model Numbers
Z305085
Z401166
Z401167
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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