Hi-Tech Pharmaceuticals product recalled over labeling errors

Recall date

August 6, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Hi-Tech Pharmaceuticals Inc. recalls HI-TECH PHARMACEUTICALS BETA SITOSTEROL (715MG PINE DERIVED PHYTOSTEROL 99%) PROVIDES SUPPORT FOR OVERALL CARDIOVASCULA…

Recall number

H-0588-2025

FDA classification

Class III

Brand / firm

Hi-Tech Pharmaceuticals Inc.

Sold / distributed

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.

Why it was recalled

Unapproved Drug Claims and Misbranded.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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