What happened
Unapproved Drug Claims and Misbranded.
What to do
Check your fridge, freezer and pantry for the product described below, and compare the brand, size and product codes carefully. If you have it, don't eat it. Throw it away or return it to the store where you bought it for a refund. If you or someone in your home ate it and feels unwell, contact a doctor. If you have a food allergy, don't eat the product even if it looks and smells normal.
Recall details
- Recall date
- Aug 6, 2025
- Country
- United States
- Company
- Hi-Tech Pharmaceuticals Inc.
- Type
- Class III
- Reason
- Unapproved Drug Claims and Misbranded.
- Product
- HI-TECH PHARMACEUTICALS BETA SITOSTEROL (715MG PINE DERIVED PHYTOSTEROL 99%) PROVIDES SUPPORT FOR OVERALL CARDIOVASCULAR HEALTH HELPS MAINTAIN HEALTHY CHOLESTEROL LEVELS ALREADY WITHIN THE NORMAL RANGE SUPPORTS PROSTATE AND IMMUNE HEALTH 90 TABLETS UPC 8 11836 02587 3 HI-TECH PHARMACEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071
- Where it was sold
- Product was shipped to the following states: 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.
- Quantity
- 85,950 units total
- Product codes
- Lot C1847 Exp Date 05/29
- Status
- Terminated
- Recall number
- H-0588-2025
Source: U.S. Food and Drug Administration (FDA). This page summarizes the official notice; the agency's notice is the authoritative version.