Hi-Tech Pharmaceuticals recalled 85,950 units of Adderex XR Strongest Focusing Aid sold nationwide after regulators found unapproved drug claims and misbranding. The product claims to boost concentration without a prescription. Consumers who bought the product should not use it and should contact the company for a refund or replacement.
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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Adderex XR is marketed as a focus aid supplement sold to adults. It is labeled to enhance concentration and productivity.
Regulators determined the product made unapproved drug claims and was misbranded. This creates potential health and regulatory risks for consumers.
This recall is not part of a broader industry pattern.
Consumers face financial loss and potential health risks from a product with unapproved claims and misbranding.
Recall details on FDA enforcement page and the provided recall link
Refunds or replacements typically processed after verification, often within 4-6 weeks
Keep bottle, packaging, receipts, and all communications with the company for records
Brand: Hi-Tech Pharmaceuticals. Product: Adderex XR Strongest Focusing Aid. Quantity: 85,950 units. Lot: 303120691. Expiration: 05/28. Form: 30-tablet bottles. Sold/distributed: Nationwide to 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 number: H-0587-2025. Recall date: 2025-08-06. Status: ACTIVE. Source: FDA enforcement report.
No injuries or incidents have been reported.
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