FDA recall H-0591-2025

Hi-Tech Pharmaceuticals Inc. · Class III · food

Product

HI-TECH PHARMACEUTICALS L-GLUTAMINE ULTRA PURE POWDER HPLC VERIFIED 99.5% PURITY CELL VOLUMIZATION MUSCLE SIZE POWER RECOVERY ENERGY STRENGTH LACTIC ACIDE ELIMINATION LEAN MUSCLE 500 GRAMS NET WT. (17.630OZ) DIETARY SUPPLEMENT UPC 8 11836 02362 6 HI-TECH PHARMECEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071

Reason for recall

Unapproved Drug Claims.

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.

Key facts

Status
Terminated
Initiation date
2025-08-06
Report date
2025-09-24
Termination date
2026-02-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Norcross, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=H-0591-2025