Beta sitosterol supplement recalled over unapproved drug claims and misbranding
Hi-Tech Pharmaceuticals Beta Sitosterol, 90 tablets, lot C1847, is recalled for unapproved drug claims and misbranding. The recall covers 85,950 units across the firm's affected products.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The rubric puts FDA Class III actions at 1 or 2, and this is a claims and labeling matter with no health hazard described.
Plain-English summary
Hi-Tech Pharmaceuticals Beta Sitosterol, 715 mg pine derived phytosterol 99%, in 90-tablet bottles, is being recalled. The affected product is lot C1847 with an expiry date of 05/29. The recall covers 85,950 units in total, shipped to states across the country.
The recall was issued for unapproved drug claims and misbranding. The FDA classified the action as Class III.
Customers holding this lot should stop using the product and can return it to the place of purchase.
The recalled product
- 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 PHA
- Manufacturer
- Hi-Tech Pharmaceuticals Inc.
- Category
- Food — Dietary Supplement
- Hazard
- unapproved-claims
- misbranding
- class-iii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot C1847 Exp Date 05/29
Distribution
Distributed in 50 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
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