Hi-Tech Pharmaceuticals recalled 85,950 units of Beta Sitosterol supplement distributed nationwide from Norcross, Georgia after regulators flagged unapproved drug claims and misbranding. The product claims cardiovascular support and cholesterol benefits without FDA approval. Consumers should not consume the product and should contact Hi-Tech Pharmaceuticals for refund or replacement by letter.
Unapproved Drug Claims and Misbranded.
Consumers who have purchased this product should not consume it. Contact Hi-Tech Pharmaceuticals Inc. for refund or replacement information. Notification method: Letter
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Beta sitosterol supplements are marketed for cardiovascular support. This recall concerns unapproved drug claims and misbranding rather than a definitive product defect.
The claims about health benefits were not approved by the FDA, rendering the labeling and marketing misleading. Consumers could rely on false health information.
This recall is not described as part of a broader industry pattern in the notice.
Consumers must avoid the product to minimize regulatory risk until refunds or replacements are issued.
FDA enforcement report H-0588-2025 and company recall notice
Refunds or replacements typically take 4-8 weeks after receipt of the recall request
Keep photos of the bottle, label, UPC, and lot numbers; save all recall notices and correspondence
Model numbers: C1847; Bottle count: 90 tablets per bottle; Quantity recalled: 85,950 units; Sold to distributors in 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; Recall date: 2025-08-06; Manufacturer: Hi-Tech Pharmaceuticals, Inc., 6015-B Unity Drive, Norcross, GA 30071; Price: Not disclosed
No injuries or incidents have been reported.
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