Hi-Tech Pharmaceuticals recalled 85,950 units of Pine Bark Supplements for unapproved drug claims and misbranding. The FDA enforcement notice lists Hi-Tech Pharmaceuticals, Inc. of Norcross, GA as the marketer. The recall cites unapproved drug claims and misbranding as the reason. Consumers should stop using the product and contact the company for refund or replacement information.
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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Pine bark extract supplements are marketed for cardiovascular health and oxidative stress support. Consumers typically buy these as dietary supplements for heart health.
The hazard relates to unapproved drug claims and misbranding, which means the product was marketed with drug-like claims not approved by the FDA.
This recall is not part of a broader industry pattern.
Consumers may have purchased products based on unverified health claims and risk financial loss from refunds.
FDA recall notice H-0592-2025; Hi-Tech Pharmaceuticals customer support materials
Refunds or replacements will be communicated by letter; processing times vary
Save all purchase records, letters, and email correspondence; photograph the product and packaging
Brand: Hi-Tech Pharmaceuticals. Product: Pine Bark Supplements. Form: 60 tablets. UPC: 8 11836 02446 3. Model/Lot: Lot C15Cl4 Exp Date 10/26. Quantity: 85,950 units. Distribution: 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. Manufacturer: Hi-Tech Pharmaceuticals, Inc. 6015-B Unity Drive Norcross, GA 30071. Recall date: 2025-08-06. Status: Active.
No specific injuries or illnesses are cited in the notice. The recall notes regulatory action based on unapproved drug claims and misbranding rather than reported injuries.
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