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H-0588-2025Class III

Hi-Tech Pharmaceuticals Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Hi-Tech Pharmaceuticals Inc.
Product type
Food / supplement / cosmetic
Status
Terminated
Report date
2025-09-24
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.
Firm state
GA
Product quantity
85,950 units total
Initiated by
Voluntary: Firm initiated
Reason for recall

Unapproved Drug Claims and Misbranded.

Product description

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

Code / lot info

Lot C1847 Exp Date 05/29

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →