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Hi-Tech Pharmaceuticals

Sleep Rx

Serving
2 Tablet(s)
Form
tablet
UPC
857084000347
DSLD
10261
Avoid-flaggedObjective label signals
Flagged excipients
1
1 avoid · 0 caution
FDA recalls
20
20 Class I / II
CAERS reports
2
FDA consumer events
Certifications
0
none recorded
1 avoid-level excipient · Every flag below links to the authority's published citation.

Supplement Facts

1 active ingredients
IngredientAmount% DV
Proprietary Blend
Proprietary Blend (Combination)
610 mg—
Flagged excipients

1 flagged · authority citations

  • ● AVOIDTitanium Dioxide
    color

    Banned in EU food products effective 2022-08 (Commission Regulation (EU) 2022/63) following EFSA Panel opinion that a safe daily intake could not be established due to genotoxicity concerns. Still GRAS in the US under 21 CFR 73.575 but EU position is stricter.

    eur-lex.europa.eu →efsa.europa.eu →ecfr.gov →
Recall history

20 FDA recalls

  1. Class III2025-08-06brand-level

    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: Unapproved Drug Claims and Misbranded.

    FDA record →
  2. Class III2025-08-06brand-level

    Top Secret Nutrition extra strength uric control fast acting multi-pronged uric acid control 30 veggie caps DIETARY SUPPLEMENT UPC 8 11226 02158 4 Distributed by: TOP SECRET NUTRITION, LLC 6015-B Unity Dr. Norcross, GA 30052

    Reason: Unapproved Drug Claims.

    FDA record →
  3. Class III2025-08-06brand-level

    HI-TECH PHARMACEUTICALS PINE BARK SUPPORTS HEART HEALTH & CIRCULATION SUPPORTS CARDIOVASCULAR HEALTH FIGHTS OXIDATIVE STRESS 60 TABLETS DIETARY SUPPLEMENT UPC 8 11836 02446 3 HI-TECH PHARMACEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071

    Reason: Unapproved Drug Claims and Misbranded.

    FDA record →
  4. Class III2025-08-06brand-level

    HI-TECH PHARMACEUTICALS QUERCETIN STRENGTHENS IMMUNE SYSTEM SUPPORTS RESPIRATORY HEALTH SUPPORTS CARDIOVASCULAR HEALTH 120 TABLETS DIETARY SUPPLEMENT UPC 8 11836 02491 3 HI-TECH PHARMACEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071

    Reason: Unapproved Drug Claims and Misbranded.

    FDA record →
  5. Class III2025-08-06brand-level

    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: Unapproved Drug Claims.

    FDA record →
  6. Class III2025-08-06brand-level

    PRIMENUTRITION PHYTOFORM FRUITS & GREENS FORMULA 30 SERVINGS DETOXIFICATION IMPROVE ENERGY SWEETENED WITH MONK FRUIT PEACH MANGO NATURALLY & ARTIFICIALLY FLAVORED NET WT 13.75 OZ (390g) DIETARY SUPPLEMENT UPC 6 38302 40906 3 Manufactured by: Prime Nutrition 6015-B Unity Drive Norcross, GA 30071

    Reason: Unapproved Drug Claims and Misbranded.

    FDA record →
  7. Class III2025-08-06brand-level

    IFN iFORCE NUTRITION JOINT HELP HEALTHY JOINTS & LIGAMENTS DIETARY SUPPLEMENT 120 CAPSULES UPC 8 54503 00226 5 Manufactured By: iForce Nutrition 6015B Unity Drive Norcross, GA 30071

    Reason: Unapproved Drug Claims.

    FDA record →
  8. Class III2025-08-06brand-level

    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

    Reason: Unapproved Drug Claims and Misbranded.

    FDA record →
  9. Class III2025-08-06brand-level

    PRIMENUTRITION PHYTOFORM FRUITS & GREENS FORMULA 30 SERVINGS DETOXIFICATION IMPROVE ENERGY SWEETENED WITH MONK FRUIT KIWI-STRAWBERRY NATURALLY & ARTIFICIALLY FLAVORED NET WT 13.75 OZ (390g) DIETARY SUPPLEMENT UPC 6 89466 70619 2 Manufactured by: Prime Nutrition 6015-b Unity Drive Norcross, GA 30071

    Reason: Unapproved Drug Claims and Misbranded.

    FDA record →
  10. Class III2025-08-06brand-level

    LGSCIENCES BATTLE HARDENER PLATINUM SERIES COMPLETE 6 WEEK CYCLE WITH PCT LEGAL GEAR DIETARY SUPPLEMENT 17-PROANDRO pBOLD FORM-XT UPC 7 44890 94151 6 MADE FOR LG SCIENCES 6015-B UNITY DR. NORCROXX, GA 30071

    Reason: Unapproved Drug Claims.

    FDA record →
  11. Class III2025-08-06brand-level

    HI-TECH PHARMACEUTICALS JOINT-RX DIETARY SUPPLEMENT 600mc Helps Rebuild Cartilage & Ease Pain Revolutionary Joint Support System 90CT UPC 8 57084 00035 4 Hi-Tech Pharmaceuticals, Inc. 6015-B Unity Dr Norcross, GA 30071

    Reason: Unapproved Drug Claims.

    FDA record →
  12. Class III2025-08-06brand-level

    HI-TECH PHARMACEUTICALS SLIMAGLUTIDE REVOLUTIONARY WEIGHT LOSS AID WITH GLUCAGON-LIKE PEPTIDE-1 (GLP-1) RECEPTOR AGONIST AND SECRETAGOGUES NOVEL GIP (GLUCOSE-DEPENDENT ISNULINOTROPIC POLYPEPTIDE) RECEPTOR AGONIST 180 TABLETS DIETARY SUPPLEMENT

    Reason: Unapproved Drug Claims and Misbranded.

    FDA record →
  13. Class I2021-04-03brand-level

    ISOMORPH 28 PURE WHEY iSOLATE COOKIES N CREAM DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89836 8 & 5lb, UPC 6 49241 87832 5 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071

    Reason: During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.

    FDA record →
  14. Class I2021-04-03brand-level

    ISOMORPH 28 PURE WHEY iSOLATE CHOCOLATE MILKSHAKE DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89876 4 & 5lb, UPC 6 49241 87830 8 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071

    Reason: During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.

    FDA record →
  15. Class I2021-04-03brand-level

    ISOMORPH 28 PURE WHEY iSOLATE CHOCOLATE FUDGE POP DIETARY SUPPLEMENT NET WT. 2lb jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071 UPC 8 11836 02223 0

    Reason: During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.

    FDA record →
  16. Class I2021-04-03brand-level

    ISOMORPH 28 PURE WHEY iSOLATE BANANA CREAM PIE DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89846 7 & 5LB, UPC 6 49241 87829 2 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071

    Reason: During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.

    FDA record →
  17. Class I2021-04-03brand-level

    ISOMORPH 28 PURE WHEY iSOLATE NEOPOLITAN ICE CREAM DIETARY SUPPLEMENT NET WT. 2lb, UPC 8 11836 02251 3 & 5lb, UPC 8 11836 02252 0 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071

    Reason: During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.

    FDA record →
  18. Class I2021-04-03brand-level

    ISOMORPH 28 PURE WHEY iSOLATE HONEY GRANOLA DIETARY SUPPLEMENT NET WT. 2LB, UPC 8 11836 02303 9 & 5lb, UPC 8 11836 02302 2 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071

    Reason: During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.

    FDA record →
  19. Class I2021-04-03brand-level

    ISOMORPH 28 PURE WHEY iSOLATE STRAWBERRY MILKSHAKE DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89866 5 & 5lb, UPC 6 49241 87835 3 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071

    Reason: During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.

    FDA record →
  20. Class I2021-04-03brand-level

    ISOMORPH 28 PURE WHEY iSOLATE SMORES DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89002 7 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071

    Reason: During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.

    FDA record →
FDA CAERS · adverse event context
2
consumer-submitted adverse event reports filed with the FDA CFSAN Adverse Event Reporting System mentioning this product or its brand.

CAERS reports are unverified consumer submissions — not adjudicated causality. Large well-known brands accumulate proportionally more reports simply due to broader use. About CAERS →

Other ingredients

Microcrystalline Cellulose · Sodium Starch Glycolate · Stearic Acid · Starch · Hydroxypropyl Methylcellulose · Magnesium Stearate · Silica · Glyceryl Triacitate

Chemically equivalent

Same formula, different brand

Products with identical sorted (ingredient, amount) tuples.