Quick Facts at a Glance
- Recall Date
- August 25, 2025
- Hazard Level
- HIGH
- Brands
- CHLORPROMAZINE HYDROCHLORIDE, AvKARE
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PREGNANT
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
- CHLORPROMAZINE HYDROCHLORIDE, AvKARE
- Product type
- Chlorpromazine Hydrochloride Tablets
- Model numbers
- Lot # 47089, Lot # 47604, Exp 12/31/25, Exp 03/31/26, NDC 50268-165-15
- UPC codes
- 50268-162, 50268-163, 50268-164, 50268-165, 50268-166, 50268-162-11, 50268-162-15, 50268-163-11 +7 more
- Sizes
- 50 tablets per carton, 5x10 unit dose
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 25, 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
Presence of a foreign substance.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact AvKARE or your healthcare provider for guidance. Notification method: E-Mail
About This Product
Chlorpromazine hydrochloride is an antipsychotic medication used to treat schizophrenia and other psychiatric conditions. It is prescription-only and supplied in unit-dose cartons.
Why This Is Dangerous
A foreign substance detected in the tablets poses a potential risk if ingested and requires immediate cessation of use.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Immediate cessation is required to minimize any potential exposure risk. Patients should contact their healthcare provider for guidance.
Practical Guidance
How to identify if yours is affected
- Check NDC 50268-165-15 on packaging.
- Inspect Lot numbers 47089 or 47604.
- Check Expiration Dates 12/31/25 or 03/31/26.
Where to find product info
FDA recall page and AvKare communications; NDC and lot numbers are on the carton label.
What timeline to expect
Refunds or replacements will be coordinated by AvKare; timelines to be provided by the company.
If the manufacturer is unresponsive
- Document all communications
- Escalate to FDA recall if AvKare is unresponsive
- Consider legal counsel if significant losses occur
How to prevent similar issues
- Verify NDC and lot numbers before dispensing medications
- Maintain clear records of recalls for medical inventory
- Adhere to updated recall notices from FDA
Documentation advice
Keep recall notices, packaging, receipts, and correspondence for records
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Product Details
Product: CHLORPROMAZINE HYDROCHLORIDE tablets, 100 mg, 50 tablets per carton. Form: Unit dose carton (5x10). Rx only. Manufactured for: AvKare, Pulaski, TN 38478. NDC: 50268-165-15. Quantity: 2003 cartons. Distribution: USA Nationwide. Existing brands: CHLORPROMAZINE HYDROCHLORIDE, AvPAK. Lot numbers: 47089; 47604. Expiration: 12/31/2025 and 03/31/2026.
Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- Lot numbers 47089 and 47604
- Exp 12/31/25 and Exp 03/31/26
- Manufactured for AvKare in Pulaski, TN
- Distribution: USA Nationwide
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Safety Guide
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