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HI-TECH PHARMACEUTICALS BETA SITOSTEROL (715MG PINE DERIVED…: FDA Recall H-0588-2025

Agency action: Aug 6, 2025Record ID: H-0588-2025
View official source ↗

What happened

Original notice title

HI-TECH PHARMACEUTICALS BETA SITOSTEROL (715MG PINE DERIVED PHYTOSTEROL 99%) PROVIDES SUPPORT FOR OVERALL CARDIOVASCULAR HEALTH HELPS MAINTAIN HEALTHY CHOLESTEROL LEVELS ALREADY WITHIN…

From the archived source record

Unapproved Drug Claims and Misbranded.

What the official notice says to do

Check the original notice for the instructions that apply to the named product, company, and affected lots.

Read the official notice →

Status and source details

Status recorded in the archive
Terminated
FDA recall classification
Class III
Recall initiated by
Voluntary: Firm initiated
Report date
Sep 24, 2025
Termination date in the archive
Feb 19, 2026
Source checked
Jul 16, 2026
Record revision
d873e714706d

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

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Source presentation by Dr. Edward M.Kim, PharmD · Clinical Director, SupplementSafety editorial team · How we prepare records

What is affected

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
Company
Hi-Tech Pharmaceuticals Inc.
Lot / identifier
Lot C1847 Exp Date 05/29
Market / distribution
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.