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
| Records | Count | Last refreshed | Source as of | Status |
| Recalls | 31 (14 Class I) | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 9 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
| Compliance actions | 3 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent Recalls
| Number | Class | Product | Date |
| H-0586-2025 | Class III | FORMUTECH NUTRITION FLEXIBLE JOINT FORMULA WITH CISSUS QUADRANGULARIS SUPPORTS TENDONS & MUSSCLES… | Aug 6, 2025 |
| H-0591-2025 | Class III | HI-TECH PHARMACEUTICALS L-GLUTAMINE ULTRA PURE POWDER HPLC VERIFIED 99.5% PURITY CELL VOLUMIZATION… | Aug 6, 2025 |
| H-0588-2025 | Class III | HI-TECH PHARMACEUTICALS BETA SITOSTEROL (715MG PINE DERIVED PHYTOSTEROL 99%) PROVIDES SUPPORT FOR… | Aug 6, 2025 |
| H-0600-2025 | Class III | PRIMENUTRITION PHYTOFORM FRUITS & GREENS FORMULA 30 SERVINGS DETOXIFICATION IMPROVE ENERGY… | Aug 6, 2025 |
| H-0587-2025 | Class III | HI-TECH PHARMACEUTICALS ADDEREX XR STRONGEST FOCUSING AID WITHOUT A PRESECRIPTION! HELPS ADULTS… | Aug 6, 2025 |
| H-0593-2025 | Class III | HI-TECH PHARMACEUTICALS SLIMAGLUTIDE REVOLUTIONARY WEIGHT LOSS AID WITH GLUCAGON-LIKE PEPTIDE-1… | Aug 6, 2025 |
| H-0599-2025 | Class III | Top Secret Nutrition extra strength uric control fast acting multi-pronged uric acid control 30… | Aug 6, 2025 |
| H-0595-2025 | Class III | IFN iFORCE NUTRITION JOINT HELP HEALTHY JOINTS & LIGAMENTS DIETARY SUPPLEMENT 120 CAPSULES UPC 8… | Aug 6, 2025 |
| H-0597-2025 | Class III | PRIMENUTRITION PHYTOFORM FRUITS & GREENS FORMULA 30 SERVINGS DETOXIFICATION IMPROVE ENERGY… | Aug 6, 2025 |
| H-0598-2025 | Class III | PRIMENUTRITION TAURINE MENTAL & ATHLETIC PERFORMANCE 125 SERVINGS SUPPORTS ENERGY PRODUCTION PROTEN… | Aug 6, 2025 |
| H-0601-2025 | Class III | PRIMENUTRITION PHYTOFORM FRUITS & GREENS FORMULA 30 SERVINGS DETOXIFICATION IMPROVE ENERGY… | Aug 6, 2025 |
| H-0596-2025 | Class III | LGSCIENCES BATTLE HARDENER PLATINUM SERIES COMPLETE 6 WEEK CYCLE WITH PCT LEGAL GEAR DIETARY… | Aug 6, 2025 |
| H-0589-2025 | Class III | HI-TECH PHARMACEUTICALS FISH OIL HEART AND BRAIN HEALTH EPA/DHA OMEGA 3 FATTY ACIDS SUPPORTS… | Aug 6, 2025 |
| H-0590-2025 | Class III | HI-TECH PHARMACEUTICALS JOINT-RX DIETARY SUPPLEMENT 600mc Helps Rebuild Cartilage & Ease Pain… | Aug 6, 2025 |
| H-0594-2025 | Class III | HI-TECH PHARMACEUTICALS QUERCETIN STRENGTHENS IMMUNE SYSTEM SUPPORTS RESPIRATORY HEALTH SUPPORTS… | Aug 6, 2025 |
| H-0592-2025 | Class III | HI-TECH PHARMACEUTICALS PINE BARK SUPPORTS HEART HEALTH & CIRCULATION SUPPORTS CARDIOVASCULAR HEALTH… | Aug 6, 2025 |
| F-0647-2021 | Class II | Lipodrene With 25mg Ephedra Extract 100CT UPC 8 57084 00056 9 | May 12, 2021 |
| F-0499-2021 | Class I | ISOMORPH 28 PURE WHEY iSOLATE CHOCOLATE FUDGE POP DIETARY SUPPLEMENT NET WT. 2lb jugs Manufactured… | Apr 3, 2021 |
| F-0502-2021 | Class I | ISOMORPH 28 PURE WHEY iSOLATE COOKIES N CREAM DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89836 8 &… | Apr 3, 2021 |
| F-0511-2021 | Class I | HI-TECH PHARMACEUTICALS PRECISION PROTEIN COOKIES & CREAM NET WT 2lbs (907g) container UPC 8 11836… | Apr 3, 2021 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
| Mar 24, 2023 | Norcross, GA | Food/Cosmetics | Official Action Indicated (OAI) | 3001859902 |
| Mar 30, 2021 | Norcross, GA | Food/Cosmetics | Official Action Indicated (OAI) | 3001859902 |
| Nov 8, 2013 | Norcross, GA | Food/Cosmetics | Official Action Indicated (OAI) | 3001859902 |
| Nov 8, 2013 | Norcross, GA | Food/Cosmetics | Official Action Indicated (OAI) | 3009492559 |
| Oct 24, 2013 | Suwanee, GA | Food/Cosmetics | No Action Indicated (NAI) | 3009492592 |
| Feb 29, 2012 | Norcross, GA | Food/Cosmetics | No Action Indicated (NAI) | 3001859902 |
| Feb 28, 2012 | Suwanee, GA | Food/Cosmetics | No Action Indicated (NAI) | 3009492592 |
| Feb 27, 2012 | Norcross, GA | Food/Cosmetics | No Action Indicated (NAI) | 3009492559 |
| Dec 8, 2009 | Norcross, GA | Food/Cosmetics | No 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.