Hi-Tech Pharmaceuticals Inc.

FDA Regulatory Profile

Hi-Tech Pharmaceuticals Inc. has 31 FDA recalls (14 Class I), 9 inspections, 0 510(k) clearances and 3 compliance actions on record.

Latest recall
H-0586-2025 · Class III · Aug 6, 2025
Latest inspection
Mar 24, 2023 · OAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls31 (14 Class I)Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections9Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions3Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
H-0586-2025Class IIIFORMUTECH NUTRITION FLEXIBLE JOINT FORMULA WITH CISSUS QUADRANGULARIS SUPPORTS TENDONS & MUSSCLES…Aug 6, 2025
H-0591-2025Class IIIHI-TECH PHARMACEUTICALS L-GLUTAMINE ULTRA PURE POWDER HPLC VERIFIED 99.5% PURITY CELL VOLUMIZATION…Aug 6, 2025
H-0588-2025Class IIIHI-TECH PHARMACEUTICALS BETA SITOSTEROL (715MG PINE DERIVED PHYTOSTEROL 99%) PROVIDES SUPPORT FOR…Aug 6, 2025
H-0600-2025Class IIIPRIMENUTRITION PHYTOFORM FRUITS & GREENS FORMULA 30 SERVINGS DETOXIFICATION IMPROVE ENERGY…Aug 6, 2025
H-0587-2025Class IIIHI-TECH PHARMACEUTICALS ADDEREX XR STRONGEST FOCUSING AID WITHOUT A PRESECRIPTION! HELPS ADULTS…Aug 6, 2025
H-0593-2025Class IIIHI-TECH PHARMACEUTICALS SLIMAGLUTIDE REVOLUTIONARY WEIGHT LOSS AID WITH GLUCAGON-LIKE PEPTIDE-1…Aug 6, 2025
H-0599-2025Class IIITop Secret Nutrition extra strength uric control fast acting multi-pronged uric acid control 30…Aug 6, 2025
H-0595-2025Class IIIIFN iFORCE NUTRITION JOINT HELP HEALTHY JOINTS & LIGAMENTS DIETARY SUPPLEMENT 120 CAPSULES UPC 8…Aug 6, 2025
H-0597-2025Class IIIPRIMENUTRITION PHYTOFORM FRUITS & GREENS FORMULA 30 SERVINGS DETOXIFICATION IMPROVE ENERGY…Aug 6, 2025
H-0598-2025Class IIIPRIMENUTRITION TAURINE MENTAL & ATHLETIC PERFORMANCE 125 SERVINGS SUPPORTS ENERGY PRODUCTION PROTEN…Aug 6, 2025
H-0601-2025Class IIIPRIMENUTRITION PHYTOFORM FRUITS & GREENS FORMULA 30 SERVINGS DETOXIFICATION IMPROVE ENERGY…Aug 6, 2025
H-0596-2025Class IIILGSCIENCES BATTLE HARDENER PLATINUM SERIES COMPLETE 6 WEEK CYCLE WITH PCT LEGAL GEAR DIETARY…Aug 6, 2025
H-0589-2025Class IIIHI-TECH PHARMACEUTICALS FISH OIL HEART AND BRAIN HEALTH EPA/DHA OMEGA 3 FATTY ACIDS SUPPORTS…Aug 6, 2025
H-0590-2025Class IIIHI-TECH PHARMACEUTICALS JOINT-RX DIETARY SUPPLEMENT 600mc Helps Rebuild Cartilage & Ease Pain…Aug 6, 2025
H-0594-2025Class IIIHI-TECH PHARMACEUTICALS QUERCETIN STRENGTHENS IMMUNE SYSTEM SUPPORTS RESPIRATORY HEALTH SUPPORTS…Aug 6, 2025
H-0592-2025Class IIIHI-TECH PHARMACEUTICALS PINE BARK SUPPORTS HEART HEALTH & CIRCULATION SUPPORTS CARDIOVASCULAR HEALTH…Aug 6, 2025
F-0647-2021Class IILipodrene With 25mg Ephedra Extract 100CT UPC 8 57084 00056 9May 12, 2021
F-0499-2021Class IISOMORPH 28 PURE WHEY iSOLATE CHOCOLATE FUDGE POP DIETARY SUPPLEMENT NET WT. 2lb jugs Manufactured…Apr 3, 2021
F-0502-2021Class IISOMORPH 28 PURE WHEY iSOLATE COOKIES N CREAM DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89836 8 &…Apr 3, 2021
F-0511-2021Class IHI-TECH PHARMACEUTICALS PRECISION PROTEIN COOKIES & CREAM NET WT 2lbs (907g) container UPC 8 11836…Apr 3, 2021

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 24, 2023Norcross, GAFood/CosmeticsOfficial Action Indicated (OAI)3001859902
Mar 30, 2021Norcross, GAFood/CosmeticsOfficial Action Indicated (OAI)3001859902
Nov 8, 2013Norcross, GAFood/CosmeticsOfficial Action Indicated (OAI)3001859902
Nov 8, 2013Norcross, GAFood/CosmeticsOfficial Action Indicated (OAI)3009492559
Oct 24, 2013Suwanee, GAFood/CosmeticsNo Action Indicated (NAI)3009492592
Feb 29, 2012Norcross, GAFood/CosmeticsNo Action Indicated (NAI)3001859902
Feb 28, 2012Suwanee, GAFood/CosmeticsNo Action Indicated (NAI)3009492592
Feb 27, 2012Norcross, GAFood/CosmeticsNo Action Indicated (NAI)3009492559
Dec 8, 2009Norcross, GAFood/CosmeticsNo Action Indicated (NAI)3001859902

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3001859902Norcross, GA5Mar 24, 2023
FEI 3009492559Norcross, GA2Nov 8, 2013
FEI 3009492592Suwanee, GA2Oct 24, 2013

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.