PlainRecalls
FDA Food Verify with FDA Food → Low Class III Terminated

PRIMENUTRITION TAURINE MENTAL & ATHLETIC PERFORMANCE 125 SERVINGS SUPPORTS ENERGY PRODUCTION PROTEN ANTIOXIDANT PROPERTIES SUPPORTS HEALTHY BLOOD SUGAR LEVELS NET WT. 8.12OZ (250g) DIETARY SUPPLEMENT UPC 6 89466 70601 7 Manufactured by: Prime Nutrition 6015-B Unity Drive Norcross, GA 30071

Reported: September 24, 2025 Initiated: August 6, 2025 #H-0598-2025 85,950 units total units

Hi-Tech Pharmaceuticals Inc. issued this FDA Food recall on September 24, 2025. Classified as Low severity (Class III). Approximately 85,950 units total units are affected. The recall was issued because: Unapproved Drug Claims and Misbranded.. This recall notice is sourced from official FDA Food enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Food action (record #H-0598-2025) was formally reported on September 24, 2025, with the manufacturer initiating the action on August 6, 2025. It is classified under Low severity (Class III), with a current status of Terminated. Hi-Tech Pharmaceuticals Inc. is listed as the recalling firm, operating out of Norcross, GA. Federal records indicate 85,950 units total units are affected.

The documented reason for this recall is: Unapproved Drug Claims and Misbranded. Distribution data in the federal record shows the product reached: 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…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Food. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Low

Units Affected

85,950 units total

Related Recalls

6

6 from same agency

Product Description

PRIMENUTRITION TAURINE MENTAL & ATHLETIC PERFORMANCE 125 SERVINGS SUPPORTS ENERGY PRODUCTION PROTEN ANTIOXIDANT PROPERTIES SUPPORTS HEALTHY BLOOD SUGAR LEVELS NET WT. 8.12OZ (250g) DIETARY SUPPLEMENT UPC 6 89466 70601 7 Manufactured by: Prime Nutrition 6015-B Unity Drive Norcross, GA 30071

Reason for Recall

Unapproved Drug Claims and Misbranded.

Details

Units Affected
85,950 units total
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.
Location
Norcross, GA

Recall Profile

Structured summary of the FDA Food recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Low (Class III)
Status Terminated
Recall number H-0598-2025
Date reported September 24, 2025
Date initiated August 6, 2025
Recalling firm Hi-Tech Pharmaceuticals Inc.
Units affected 85,950 units total
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…

Profile values are sourced directly from the official FDA Food enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

85,950 units total units affected — limited or regional distribution scale.

Regional (<10K units)
Multi-state (10K – 100K units) ✓ This recall
Large-scale (100K – 1M units)
Massive (≥1M units)

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

Frequently Asked Questions

What product was recalled?
PRIMENUTRITION TAURINE MENTAL & ATHLETIC PERFORMANCE 125 SERVINGS SUPPORTS ENERGY PRODUCTION PROTEN ANTIOXIDANT PROPERTIES SUPPORTS HEALTHY BLOOD SUGAR LEVELS NET WT. 8.12OZ (250g) DIETARY SUPPLEMENT UPC 6 89466 70601 7 Manufactured by: Prime Nutrition 6015-B Unity Drive Norcross, GA 30071. Recalled by Hi-Tech Pharmaceuticals Inc.. Units affected: 85,950 units total.
Why was this product recalled?
Unapproved Drug Claims and Misbranded.
Which agency issued this recall?
This recall was issued by the FDA Food on September 24, 2025. Severity: Low. Recall number: H-0598-2025.
Where was the recalled product distributed?
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..
How do I check if my product is affected by a recall?
Check the product description and recall number (H-0598-2025) against your product. Visit the official FDA Food website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
What are the health risks of consuming a recalled food product?
Recalled food products may contain contaminants, undeclared allergens, or harmful bacteria such as Salmonella, Listeria, or E. coli. Consuming these products can cause foodborne illness ranging from mild gastrointestinal symptoms to serious conditions requiring hospitalization. If you have consumed a recalled food product and experience symptoms, contact your healthcare provider and report to the FDA via MedWatch.

Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. Recall severity varies based on the likelihood and degree of potential harm to consumers. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

Compare this recall with Lowes Foods sour cream and onion flavored potato chips, 8oz… →

Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
  • Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

All federal data sources used on this page

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).