Quick Facts at a Glance
- Recall Date
- August 25, 2025
- Hazard Level
- HIGH
- Brands
- AvKare, CHLORPROMAZINE HYDROCHLORIDE
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
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
- AvKare, CHLORPROMAZINE HYDROCHLORIDE
- Product type
- Chlorpromazine hydrochloride tablets
- Model numbers
- Lot # 46824, Lot # 47171, Exp 9/30/25, Exp 12/31/25
- 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 mg
- 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 for various psychiatric conditions. The 50 mg tablet is supplied in unit-dose cartons for clinical use.
Why This Is Dangerous
Contamination with foreign substances can cause adverse reactions or require medical evaluation. Consumers should avoid use until guidance is provided by AvKare.
Industry Context
This recall is not part of a broader industry pattern in this dataset.
Real-World Impact
Immediate halt to use is required to prevent potential adverse events. Patients may require clinical guidance and possible product replacement.
Practical Guidance
How to identify if yours is affected
- Inspect cartons for NDC 50268-164-15
- Verify lot numbers 46824 or 47171
- Check expiration dates 9/30/25 or 12/31/25
Where to find product info
NDC on front panel; lot number and expiration date on carton and seal
What timeline to expect
Replacement or refund process not specified; follow manufacturer guidance; anticipated processing timelines typical for drug recalls (weeks to months)
If the manufacturer is unresponsive
- Document the request
- Escalate to FDA recall enforcement or your healthcare provider
- Contact patient safety or hospital pharmacy for guidance
How to prevent similar issues
- Verify NDC before dispensing
- Maintain up-to-date supplier recalls
- Report any adverse events to FDA MedWatch and hospital risk management
Documentation advice
Keep recall notice, purchase records, lot numbers, expiration dates, and all correspondence
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Product Details
Product: CHLORPROMAZINE HYDROCHLORIDE tablets, 50 mg, 50 tablets per carton (5x10 unit dose). NDC 50268-164-15. Sold nationwide in the USA. Manufacturer: AvKare, Pulaski, TN 38478. Quantity: 1,512 cartons. Lot numbers/Exp: Lot # 46824; Exp 9/30/25; Lot 47171; Exp 12/31/25. Status: Active recall as of 2025-08-25; Report date 2025-09-17.
Reported Incidents
No injuries or incidents have been reported in the provided recall notice.
Key Facts
- Active recall as of 2025-09-17
- USA nationwide distribution
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Safety Guide
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