Quick Facts at a Glance
- Recall Date
- August 6, 2025
- Hazard Level
- HIGH
- Brand
- Hi-Tech Pharmaceuticals
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- Nationwide (50 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 - Food 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
- Hi-Tech Pharmaceuticals
- Product type
- Beta Sitosterol supplement
- Model numbers
- C1847
- Sold at
- Unknown
- Where affected
- Nationwide
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 6, 2025
Reported by FDA FOOD
September 24, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Unapproved Drug Claims and Misbranded.
What You Should Do
Consumers who have purchased this product should not consume it. Contact Hi-Tech Pharmaceuticals Inc. for refund or replacement information. Notification method: Letter
About This Product
Beta sitosterol supplements are marketed for cardiovascular support. This recall concerns unapproved drug claims and misbranding rather than a definitive product defect.
Why This Is Dangerous
The claims about health benefits were not approved by the FDA, rendering the labeling and marketing misleading. Consumers could rely on false health information.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Consumers must avoid the product to minimize regulatory risk until refunds or replacements are issued.
Practical Guidance
How to identify if yours is affected
- Check product label for Hi-Tech Pharmaceuticals Beta Sitosterol 715 mg
- Model number: C1847
- Bottle count: 90 tablets per bottle
Where to find product info
FDA enforcement report H-0588-2025 and company recall notice
What timeline to expect
Refunds or replacements typically take 4-8 weeks after receipt of the recall request
If the manufacturer is unresponsive
- Submit a written request by mail to the company address
- File a consumer protection complaint with the CPSC if the company is unresponsive
- Document all attempts at contact and keep copies of correspondence
How to prevent similar issues
- Vet claims on dietary supplements to ensure FDA approval status
- Prefer products with clear FDA clearance or disclaimer
- Keep receipts and packaging for recalls
Documentation advice
Keep photos of the bottle, label, UPC, and lot numbers; save all recall notices and correspondence
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Product Details
Model numbers: C1847; Bottle count: 90 tablets per bottle; Quantity recalled: 85,950 units; Sold to distributors in AL, AR, AZ, CA, CO, CT, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY; Recall date: 2025-08-06; Manufacturer: Hi-Tech Pharmaceuticals, Inc., 6015-B Unity Drive, Norcross, GA 30071; Price: Not disclosed
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 85,950 total recalled units
- 90 tablets per bottle
- Distributed to multiple states across the U.S. and territories
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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