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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Zydus Lifesciences, Northstar Rx LLC
- Product type
- Chlorpromazine Hydrochloride Tablets 50 mg
- Model numbers
- Z306326, Z401155
- UPC codes
- 16714-047, 16714-048, 16714-049, 16714-050, 16714-051, 16714-047-01, 16714-048-01, 16714-049-01 +2 more
- Sizes
- 50 mg, 100-count
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 3, 2025
Reported by FDA DRUG
September 17, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
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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
- Manufactured by Zydus Lifesciences Ltd. (India)
- Distributed nationwide in the USA by Northstar Rx LLC
- Model numbers Z306326 and Z401155
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Safety Guide
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