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Recall Observatory FDA recall evidence

Food 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

H-0588-2025

August 06, 2025

Class III

Product summary

Firm
Hi-Tech Pharmaceuticals Inc.
Event
Event 97373
Status
Terminated
Classification
Class III
Quantity
85,950 units total
Official record key
food-enforcement:H-0588-2025

Official wording

Reason: Unapproved Drug Claims and Misbranded.

Code information: Lot C1847 Exp Date 05/29

Distribution pattern: 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.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Misbranded