Class IIITerminated in FDA datasetAug 6, 2025

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

Recalling firm: Hi-Tech Pharmaceuticals Inc.

Why it was recalled

Unapproved Drug Claims and Misbranded.

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The exact 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

Check the codes

Compare these FDA-provided codes, lot numbers or dates with the product you have.

Match the product, size and code together. A similar name alone does not identify your batch.

Original FDA code information

Lot C1847 Exp Date 05/29

TypeCode / valueContext
UPC811836025873EADY 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

Recall details

Recall number
H-0588-2025
Event ID
97373
FDA status
Terminated
Initiated
Aug 6, 2025
Reported
Sep 24, 2025
Classified
Sep 12, 2025
Terminated
Feb 19, 2026
Quantity
85,950 units total
Location
Norcross, GA, United States
Initiation type
Voluntary: Firm initiated
Notification
Letter

Where it was 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.

FDA source record · H-0588-2025

Data updated September 16, 2026. View official FDA data ↗

A missing code match is not a guarantee of safety. Follow official FDA and manufacturer guidance.