CLASS III Food recall · Reported 24 Sep 2025 · FDA Enforcement Report
Beta Sitosterol (715mg Pine Derived Phytosterol 99%) recalled
Hi-Tech Pharmaceuticals is recalling Beta Sitosterol (715mg Pine Derived Phytosterol 99%) Provides Support For Overall, distributed in 49 states. The recall was initiated on 6 Aug 2025 and the FDA has classified it as Class III.
Check your package
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
Recall details
- Recall number
- H-0588-2025
- FDA event ID
- 97373
- Recalling firm
- Hi-Tech Pharmaceuticals, Norcross, GA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 6 Aug 2025
- FDA classified
- 12 Sep 2025
- Reported
- 24 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Product category
- Other
Timeline
| 6 Aug 2025 | Recall initiated by company | |
| 12 Sep 2025 | Classified by FDA | +37 days |
| 24 Sep 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Unapproved Drug Claims and Misbranded.
Product as listed by the FDA
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
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.
AlabamaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichigan
Questions about this recall
Why was it recalled?
Unapproved Drug Claims and Misbranded.
Which lots are affected?
Lot C1847 Exp Date 05/29
Where was it sold?
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.
What should I do if I have it?
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
15 other products · FDA event 97373This product is part of a recall event; the main page for the event is Primenutrition Taurine Mental & Athletic Performance recalled.
More recalls from Hi-Tech Pharmaceuticals
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|---|---|---|---|---|---|
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| Food | CLASS III | Primenutrition Phytoform Fruits & Greens Formula recalledPrimenutrition Phytoform | Hi-Tech Pharmaceuticals | Labeling Errors | 49 states |
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