Recall · openFDA Food Enforcement
HI-TECH PHARMACEUTICALS ADDEREX XR STRONGEST FOCUSING AID…: FDA Recall H-0587-2025 Agency action: Aug 6, 2025 Record ID: H-0587-2025
View official source ↗ What happened Original notice title
HI-TECH PHARMACEUTICALS ADDEREX XR STRONGEST FOCUSING AID WITHOUT A PRESECRIPTION! HELPS ADULTS MAINTAIN CONCENTRATION & IMPROVE PRODUCTIVITY! 30 TABLETS UPC 8 11836 02691 7 HI-TECH…
From the archived source record
Unapproved Drug Claims and Misbranded.
What the official notice says to do Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice → Status and source details
Status recorded in the archive Terminated
FDA recall classification Class III
Recall initiated by Voluntary: Firm initiated
Report date Sep 24, 2025
Termination date in the archive Feb 19, 2026
Source checked Jul 16, 2026
Record revision c431907a37ee This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage → What is affected Product HI-TECH PHARMACEUTICALS ADDEREX XR STRONGEST FOCUSING AID WITHOUT A PRESECRIPTION! HELPS ADULTS MAINTAIN CONCENTRATION & IMPROVE PRODUCTIVITY! 30 TABLETS UPC 8 11836 02691 7 HI-TECH PHARMACEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071 Company Hi-Tech Pharmaceuticals Inc. Lot / identifier Lot 303120691 Exp Date 05/28 Market / distribution 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. Quantity reported 85,950 units total What is affected Product HI-TECH PHARMACEUTICALS ADDEREX XR STRONGEST FOCUSING AID WITHOUT A PRESECRIPTION! HELPS ADULTS MAINTAIN CONCENTRATION & IMPROVE PRODUCTIVITY! 30 TABLETS UPC 8 11836 02691 7 HI-TECH PHARMACEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071 Company Hi-Tech Pharmaceuticals Inc. Lot / identifier Lot 303120691 Exp Date 05/28 Market / distribution 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. 