HI-TECH PHARMACEUTICALS BETA SITOSTEROL — Class III food recall H-0588-2025
Terminated recall by Hi-Tech Pharmaceuticals Inc., reported 2025-09-24, distributed in AL, AR, AZ, CA, CO, CT, DE, FL…. Unapproved Drug Claims and Misbranded.
| Recall number | H-0588-2025 |
|---|---|
| Product type | Food |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hi-Tech Pharmaceuticals Inc., Norcross, GA, United States |
| Recall initiated | 2025-08-06 |
| Classified | 2025-09-12 |
| Reported by FDA | 2025-09-24 |
| Terminated | 2026-02-19 |
| Distributed | 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 |
| Quantity | 85,950 units |
| Reason classes | labeling, unapproved product |
| UPC / GTIN / UDI-DI | 00811836025873 |
| Lot numbers | 05/29, C1847 |
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
Reason for recall
Unapproved Drug Claims and Misbranded.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/H-0588-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.