PRIMENUTRITION PHYTOFORM FRUITS & GREENS FORMULA 30 SERVINGS DETOXIFICATION IMPROVE ENERGY SWEETENED WITH MONK FRUIT WA
Summary
The FDA issued a Class III for PRIMENUTRITION PHYTOFORM FRUITS & GREENS FORMULA 30 SERVINGS DETOXIFICATION IMP by Hi-Tech Pharmaceuticals Inc.. Reason: Unapproved Drug Claims and Misbranded..
Details
Source
Food Recall
External ID
H-0601-2025
Action Date
2025-09-24
Status
Terminated
Category
food
Product Description
PRIMENUTRITION PHYTOFORM FRUITS & GREENS FORMULA 30 SERVINGS DETOXIFICATION IMPROVE ENERGY SWEETENED WITH MONK FRUIT WATERMELON NATURALLY & ARTIFICIALLY FLAVORED NET WT 13.75 OZ (390g) DIETARY SUPPLEMENT UPC 6 38302 40905 6 Manufactured by: Prime Nutrition 6015-B Unity Drive Norcross, GA 30071
Lot/Code Info: Lot 174271126 Exp Date 09/26
Quantity Affected: 85,950 units total
Reason for Recall
Unapproved Drug Claims and Misbranded.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-06
Company
Norcross, GA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 51 food recalls issued in the same week, part of 204 food-related FDA actions this month.
Hi-Tech Pharmaceuticals Inc. has 16 FDA actions in our database, including 16 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hi-Tech Pharmaceuticals Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hi-Tech Pharmaceuticals Inc. have FDA actions?
Hi-Tech Pharmaceuticals Inc. has 16 FDA actions in our database, including 16 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "H-0601-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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