H-0591-2025 Class III Terminated

Recalled by Hi-Tech Pharmaceuticals Inc. — Norcross, GA

FDA food recall H-0591-2025 was initiated by Hi-Tech Pharmaceuticals Inc. on Aug 6, 2025 and is designated Class III. Reason for recall: Unapproved Drug Claims. The recall status is terminated (terminated Feb 19, 2026). Affected quantity: 85,950 units total.

Recall Details

Product Type
Food
Report Date
Sep 24, 2025
Initiation Date
Aug 6, 2025
Termination Date
Feb 19, 2026
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
85,950 units total

Product Description

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 Pattern

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.

Code Information

Lot 059960809 Exp Date 06/28

Source

Dataset
openFDA food recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for H-0591-2025
openFDA file date
Nov 3, 2026
Loaded by RegDataLab
Nov 8, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for H-0591-2025. Report a data issue: hello@regdatalab.com.