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Class IIITerminated in FDA datasetRecall initiated Aug 6, 2025

Hi-Tech Pharmaceuticals Beta Sitosterol (715mg Pine Derived Phytosterol 99%) Provides Support…

Recalling firm: Hi-Tech Pharmaceuticals Inc.

Why it was recalled

Unapproved Drug Claims and Misbranded.

Historical recall record. This is not a new recall announcement. “Terminated” describes the FDA recall process; it does not certify that an individual package is safe. FDA termination date: Feb 19, 2026.

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Compare the exact product and package details with the label you have.

ProductHI-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
UPC811836025873

FDA code information

Lot C1847 Exp Date 05/29

Match the product, package size, and code together. A missing match does not guarantee safety.

Full FDA record and distribution details

Original 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

Extracted codes and context

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

Original FDA recall reason

Unapproved Drug Claims and Misbranded.

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 ↗

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