Is this recall active and what product is affected?

Yes. The recall concerns Chlorpromazine Hydrochloride Tablets, 50 mg, 100-count bottles manufactured by Zydus Lifesciences and distributed by Northstar Rx LLC.

Should I stop taking the medication?

Yes. Stop using the product and consult a healthcare provider for guidance.

How can I identify if my bottle is affected?

Check the NDC 16714-049-01 on the bottle label. Also verify the 50 mg strength and 100-count packaging.

Where was the drug manufactured?

Manufactured by Zydus Lifesciences Ltd., Baddi, India for Northstar Rx LLC in Memphis, TN.

What should I do to obtain a refund or replacement?

Follow the manufacturer’s instructions and monitor the FDA recall page for updates on refunds or replacements.

Are there any injuries or deaths associated with this recall?

No injuries or incidents have been reported as of the recall notice.

Where can I find more information about this recall?

Refer to the FDA enforcement page for D-0635-2025 and the recall notices from Zydus Lifesciences and Northstar Rx LLC.

What is N-Nitroso Desmethyl Chlorpromazine?

It is a nitrosamine impurity that can pose health risks if ingested at certain levels; the recall addresses this contamination concern.

Who should I contact for medical questions about this drug?

Contact your healthcare provider for medical guidance and the manufacturer for recall-related questions.

Will other chlorpromazine products be affected?

This recall specifically covers the identified NDC and associated packaging; other products may be unaffected. Check the recall notice for details.

What can I do to prevent future recalls of this type?

Buy medicines from licensed pharmacies, verify NDC numbers, and look for CGMP-compliant labeling and supplier information.

HIGHSeptember 3, 2025

Zydus Lifesciences Chlorpromazine Hydrochloride Tablets 50 mg 100-count Recall 2025

Q: What is the hazard causing the recall?

CGMP deviations leading to presence of N-Nitroso Desmethyl Chlorpromazine above the acceptable intake limit.

Zydus Lifesciences and Northstar Rx LLC recall Chlorpromazine Hydrochloride Tablets, 50 mg, 100-count bottles distributed nationwide in the United States. The recall cites CGMP deviations and the presence of N-Nitroso Desmethyl Chlorpromazine above the acceptable intake limit. Stop using the product immediately and contact your healthcare provider or Zydus Pharmaceuticals (USA) Inc for guidance.

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

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 hydrochloride is a prescription antipsychotic used to treat certain mental disorders. This recall involves a 50 mg, 100-count bottle intended for Rx use.

Why This Is Dangerous

The recall cites CGMP deviations resulting in the impurity N-Nitroso Desmethyl Chlorpromazine exceeding acceptable intake limits.

Industry Context

This recall is not described as part of a broader industry pattern in the provided information.

Real-World Impact

Exposure to the impurity could pose long-term health risks. There are no reported injuries or incidents yet. Consumers should stop use and seek guidance from a healthcare provider.

Practical Guidance

How to identify if yours is affected

Locate the bottle label for 'Chlorpromazine Hydrochloride Tablets, 50 mg, 100-count'
Check the NDC 16714-049-01 on the label
Confirm manufacturer as Zydus Lifesciences and distributor Northstar Rx LLC

Where to find product info

NDC on the bottle label and packaging; recall page on FDA site

What timeline to expect

Refunds or replacements will be determined by the manufacturer; monitor updates from FDA and company communications (no specific timeframe provided)

If the manufacturer is unresponsive

File a complaint with FDA MedWatch if adverse events occur or recall communications are slow
Consult your pharmacist or healthcare provider for alternatives and guidance

How to prevent similar issues

Purchase medications only from licensed pharmacies
Verify NDC and packaging before use
Keep recall notices and packaging for reference
Ask for pharmacist guidance when switching to alternatives

Documentation advice

Retain the bottle, packaging, recall notification, and any communications with the manufacturer or healthcare provider

Product Details

Model numbers: Z306326; Z401155 Where sold: Nationwide in the USA When sold: N/A Price: N/A

Reported Incidents

No injuries or incidents have been reported.

Key Facts

16714-049-01 NDC on product label
50 mg strength per tablet
100-count bottle
Manufactured by Zydus Lifesciences Ltd. (India)
Distributed nationwide in the USA by Northstar Rx LLC
Model numbers Z306326 and Z401155

View Original Recall on FDA - Drug Safety

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

POISONINGOTHER

Product Classification

CategoryHealth & Personal Care › Drugs & Medications

Product TypeChlorpromazine Hydrochloride Tablets 50 mg

Product Details

Brands

Zydus Lifesciences Northstar Rx LLC

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