Unauthorised substance or claim: food recalls in the United States
603 official food recall notices published by the U.S. Food and Drug Administration (FDA) in the United States for the reason “Unauthorised substance or claim” (Shelfpedia classification of the official reason), newest first. Each notice links to the official page.
By reason
By year
Notices
603 notices, newest first · page 1 of 13.
- October 14, 2026reportedFDAClass IUnauthorised substance or claim
X10 Natural Enhancement Supplement, 0.5 fl oz/sachet (15 mL), 7 sachets/box, UPC: 7708075247094, Manufactured by FutuPro S.A.S., Colombian Industry…
Official wording (English):
Product contains undeclared Sildenafil and Tadalafil.
- October 14, 2026reportedFDAClass IUnauthorised substance or claim
biQ-FEL, 16.9 fl oz (500 mL), 17 servings per bottle, Manufactured by ALMENAT SAS AV 39 OESTE No 10 OESTE-18 CALI VALLE INDUSTRIA COLOMBIANA; Distributed by…
Official wording (English):
Product contains undeclared Sildenafil and Tadalafil.
- September 2, 2026reportedFDAClass IUnauthorised substance or claim
Addall XR Shot 1 single bottle, 2 fl. oz., liquid dietary supplement
Official wording (English):
The product contains 1,4-DMAA, Phenylethylamine and Phenibut.
- August 12, 2026reportedFDAClass IUnauthorised substance or claim
Ashfiat Alharamain Energy Support 250ml/8fl. oz.
Official wording (English):
Undeclared tadalafil
- July 29, 2026reportedFDAClass IUnauthorised substance or claim
Modern Warrior Ready, Dietary Supplement, 60 CAPSULES
Official wording (English):
FDA analysis revealed the presence of unapproved ingredients including tianeptine, 1,4 DMAA, and aniracetam.
- April 15, 2026reportedFDAClass IUnauthorised substance or claim
Boner Bears Honey Male Enhancement 100% Wildflower Honey, total of 15 pouches per box, Net Wt 15 G each pouch. Dosage: Consume 1 entire pouch 30 minutes before…
Official wording (English):
FDA analysis revealed the presence of undeclared sildenafil and Tadalafil
- April 15, 2026reportedFDAClass IUnauthorised substance or claim
Blue Bull Extreme Male Enhancement Supplement, total of 15 pouches per box, Net Wt 15 G each pouch. Dosage: Consume Entire Pouch 30 Minutes before Intercourse.…
Official wording (English):
FDA analysis revealed the presence of undeclared sildenafil
- April 15, 2026reportedFDAClass IUnauthorised substance or claim
Red Bull Extreme Male Enhancement Supplement, total of 15 pouches per box, Net Wt 15 G each pouch. Dosage: Consume Entire Pouch 30 Minutes before Intercourse.…
Official wording (English):
FDA analysis revealed the presence of undeclared sildenafil
- January 21, 2026reportedFDAClass IIUnauthorised substance or claim
Jumbo RAW SHRIMP, All Natural, Chemical Free, No artificial ingredients, NET WT. 32 OZ (2 LB) 907g UPC: 1 93968 00697 6
Official wording (English):
elevated levels of chloramphenicol in frozen shrimp
- December 31, 2025reportedFDAClass IIUnauthorised substance or claim
Anti-virus Herbal Supplement, 1:5 Alcohol Tincture, Helps to stop viral replication, expectorant properties, Contains: Forsethia blossoms, Sumac berries, Pine…
Official wording (English):
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
- December 31, 2025reportedFDAClass IIUnauthorised substance or claim
Baby Allergy Herbal Supplement, Contains: Echinacea Purpurea, Oregon Grape Root, Dandelion & Burdock Root, Fenugreek, Ginger Root in vegetable glycerin…
Official wording (English):
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
- December 31, 2025reportedFDAClass IIUnauthorised substance or claim
Baby Soothe Herbal Supplement, Promotes rest, helps ease colic, upset stomach, and teething discomfort, Contains: Catnip, Chamomile, Vegetable Glycerin, water…
Official wording (English):
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
- December 31, 2025reportedFDAClass IIUnauthorised substance or claim
Boswellia Herbal Supplement, 1:5 Alcohol Double Extract, Extracted from Frankincense with powerful anti-inflammatory properties, useful for pain &…
Official wording (English):
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
- December 31, 2025reportedFDAClass IIUnauthorised substance or claim
Chaga Mushroom Herbal Supplement, 1:5 Alcohol Double Extract, Supports a healthy immune system with anti-cancer properties; packaged in a 2 oz. glass dropper…
Official wording (English):
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
- December 31, 2025reportedFDAClass IIUnauthorised substance or claim
Ear Drops Herbal Supplement, Mullein flower alcohol tincture 1:5, Pain relieving and antibiotic properties, packaged in a 0.5 oz. plastic dropper bottle
Official wording (English):
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
- December 31, 2025reportedFDAClass IIUnauthorised substance or claim
Organic Ginger Root Herbal Supplement, Natural anti-inflammatory properties, supports gut, increases circulation, 50 capsules/560 mg, packaged in a plastic bag
Official wording (English):
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
- December 31, 2025reportedFDAClass IIUnauthorised substance or claim
Pain Away Herbal Supplement, Analgesic & anti-inflammatory properties, Wood Betony & White Willow in vegetable glycerin, packaged in a 4.5 oz. glass bottle or…
Official wording (English):
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
- December 31, 2025reportedFDAClass IIUnauthorised substance or claim
Sinus Cap Herbal Supplement, Herbs containing antibiotic, drying, expectorant, and emollient properties, Fenugreek, Thyme, Oregon Grape Root, & Bentonite Clay…
Official wording (English):
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
- September 24, 2025reportedFDAClass IIIUnauthorised substance or claim
FORMUTECH NUTRITION FLEXIBLE JOINT FORMULA WITH CISSUS QUADRANGULARIS SUPPORTS TENDONS & MUSSCLES PROMOTES HEALTH CARTILAGE LUBRICATES JOINTS 240 Capsules UPC…
Official wording (English):
Unapproved Drug Claims.
- September 24, 2025reportedFDAClass IIIUnauthorised substance or claim
HI-TECH PHARMACEUTICALS ADDEREX XR STRONGEST FOCUSING AID WITHOUT A PRESECRIPTION! HELPS ADULTS MAINTAIN CONCENTRATION & IMPROVE PRODUCTIVITY! 30 TABLETS UPC 8…
Official wording (English):
Unapproved Drug Claims and Misbranded.
- September 24, 2025reportedFDAClass IIIUnauthorised substance or claim
HI-TECH PHARMACEUTICALS BETA SITOSTEROL (715MG PINE DERIVED PHYTOSTEROL 99%) PROVIDES SUPPORT FOR OVERALL CARDIOVASCULAR HEALTH HELPS MAINTAIN HEALTHY…
Official wording (English):
Unapproved Drug Claims and Misbranded.
- September 24, 2025reportedFDAClass IIIUnauthorised substance or claim
HI-TECH PHARMACEUTICALS FISH OIL HEART AND BRAIN HEALTH EPA/DHA OMEGA 3 FATTY ACIDS SUPPORTS CARDIOVASCULAR HEALTH MAY HELP WITH JOINT PAIN MAY IMPROVE…
Official wording (English):
Unapproved Drug Claims.
- September 24, 2025reportedFDAClass IIIUnauthorised substance or claim
HI-TECH PHARMACEUTICALS JOINT-RX DIETARY SUPPLEMENT 600mc Helps Rebuild Cartilage & Ease Pain Revolutionary Joint Support System 90CT UPC 8 57084 00035 4…
Official wording (English):
Unapproved Drug Claims.
- September 24, 2025reportedFDAClass IIIUnauthorised substance or claim
HI-TECH PHARMACEUTICALS L-GLUTAMINE ULTRA PURE POWDER HPLC VERIFIED 99.5% PURITY CELL VOLUMIZATION MUSCLE SIZE POWER RECOVERY ENERGY STRENGTH LACTIC ACIDE…
Official wording (English):
Unapproved Drug Claims.
- September 24, 2025reportedFDAClass IIIUnauthorised substance or claim
HI-TECH PHARMACEUTICALS PINE BARK SUPPORTS HEART HEALTH & CIRCULATION SUPPORTS CARDIOVASCULAR HEALTH FIGHTS OXIDATIVE STRESS 60 TABLETS DIETARY SUPPLEMENT UPC…
Official wording (English):
Unapproved Drug Claims and Misbranded.
- September 24, 2025reportedFDAClass IIIUnauthorised substance or claim
HI-TECH PHARMACEUTICALS SLIMAGLUTIDE REVOLUTIONARY WEIGHT LOSS AID WITH GLUCAGON-LIKE PEPTIDE-1 (GLP-1) RECEPTOR AGONIST AND SECRETAGOGUES NOVEL GIP…
Official wording (English):
Unapproved Drug Claims and Misbranded.
- September 24, 2025reportedFDAClass IIIUnauthorised substance or claim
HI-TECH PHARMACEUTICALS QUERCETIN STRENGTHENS IMMUNE SYSTEM SUPPORTS RESPIRATORY HEALTH SUPPORTS CARDIOVASCULAR HEALTH 120 TABLETS DIETARY SUPPLEMENT UPC 8…
Official wording (English):
Unapproved Drug Claims and Misbranded.
- September 24, 2025reportedFDAClass IIIUnauthorised substance or claim
IFN iFORCE NUTRITION JOINT HELP HEALTHY JOINTS & LIGAMENTS DIETARY SUPPLEMENT 120 CAPSULES UPC 8 54503 00226 5 Manufactured By: iForce Nutrition 6015B Unity…
Official wording (English):
Unapproved Drug Claims.
- September 24, 2025reportedFDAClass IIIUnauthorised substance or claim
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…
Official wording (English):
Unapproved Drug Claims.
- September 24, 2025reportedFDAClass IIIUnauthorised substance or claim
PRIMENUTRITION PHYTOFORM FRUITS & GREENS FORMULA 30 SERVINGS DETOXIFICATION IMPROVE ENERGY SWEETENED WITH MONK FRUIT KIWI-STRAWBERRY NATURALLY & ARTIFICIALLY…
Official wording (English):
Unapproved Drug Claims and Misbranded.
- September 24, 2025reportedFDAClass IIIUnauthorised substance or claim
PRIMENUTRITION TAURINE MENTAL & ATHLETIC PERFORMANCE 125 SERVINGS SUPPORTS ENERGY PRODUCTION PROTEN ANTIOXIDANT PROPERTIES SUPPORTS HEALTHY BLOOD SUGAR LEVELS…
Official wording (English):
Unapproved Drug Claims and Misbranded.
- September 24, 2025reportedFDAClass IIIUnauthorised substance or claim
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…
Official wording (English):
Unapproved Drug Claims.
- September 24, 2025reportedFDAClass IIIUnauthorised substance or claim
PRIMENUTRITION PHYTOFORM FRUITS & GREENS FORMULA 30 SERVINGS DETOXIFICATION IMPROVE ENERGY SWEETENED WITH MONK FRUIT PEACH MANGO NATURALLY & ARTIFICIALLY…
Official wording (English):
Unapproved Drug Claims and Misbranded.
- September 24, 2025reportedFDAClass IIIUnauthorised substance or claim
PRIMENUTRITION PHYTOFORM FRUITS & GREENS FORMULA 30 SERVINGS DETOXIFICATION IMPROVE ENERGY SWEETENED WITH MONK FRUIT WATERMELON NATURALLY & ARTIFICIALLY…
Official wording (English):
Unapproved Drug Claims and Misbranded.
- December 11, 2024reportedFDAClass IIUnauthorised substance or claim
OneMultivitaminic GAF-PLUS Advance 300ml, plastic bottle, Room Temperature
Official wording (English):
Contains undeclared drugs Acetaminophen and Dexamethasone Phosphate, and the undeclared sweetener Aspartame
- April 3, 2024reportedFDAClass IIUnauthorised substance or claim
Himalayan Pain Relief Tea for Gout and Hangover
Official wording (English):
Contains undeclared drugs Diclofenac and Dexamethasone Acetate
- February 7, 2024reportedFDAClass IIUnauthorised substance or claim
Notoginseng Formula Special Gout Granule; 100% Natural; 8 G x 10 PACKS; CITI TRADE INT'L LIMITED; ADDRESS: 3/FINTERNATIONAL PLAZA 20 SHEUNG YUET RD, KOWLOON…
Official wording (English):
Product contains undeclared Diclofenac and Dexamethasone Acetate
- January 31, 2024reportedFDAClass IUnauthorised substance or claim
Tapee Tea packaged in paper packets - 5 packets per bag
Official wording (English):
Samples confirm presence of dexamethasone and piroxicam
- November 15, 2023reportedFDAClass IIUnauthorised substance or claim
Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.
Official wording (English):
Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive
- May 31, 2023reportedFDAClass IIUnauthorised substance or claim
truCONTROL 60 Count
Official wording (English):
The products contain DMHA and/or hordenine which FDA has determined are not acceptable dietary ingredients.
- May 31, 2023reportedFDAClass IIUnauthorised substance or claim
TruControl 7 Day Trifold
Official wording (English):
The products contain DMHA and/or hordenine which FDA has determined are not acceptable dietary ingredients.
- May 31, 2023reportedFDAClass IIUnauthorised substance or claim
reFORM
Official wording (English):
The products contain DMHA and/or hordenine which FDA has determined are not acceptable dietary ingredients.
- May 31, 2023reportedFDAClass IIUnauthorised substance or claim
truControl W/Dynamine 60 ct
Official wording (English):
The products contain DMHA and/or hordenine which FDA has determined are not acceptable dietary ingredients.
- May 31, 2023reportedFDAClass IIUnauthorised substance or claim
TruWeight and Energy Gen 2+ 60 Count
Official wording (English):
The products contain DMHA and/or hordenine which FDA has determined are not acceptable dietary ingredients.
- May 31, 2023reportedFDAClass IIUnauthorised substance or claim
TruWeight and Energy Gen 2+ Trifold
Official wording (English):
The products contain DMHA and/or hordenine which FDA has determined are not acceptable dietary ingredients.
- May 31, 2023reportedFDAClass IIUnauthorised substance or claim
Truvy 30-Day Experience Kit
Official wording (English):
The products contain DMHA and/or hordenine which FDA has determined are not acceptable dietary ingredients.
- May 31, 2023reportedFDAClass IIUnauthorised substance or claim
Truvy 7-Day Experience Kit
Official wording (English):
The products contain DMHA and/or hordenine which FDA has determined are not acceptable dietary ingredients.
- May 31, 2023reportedFDAClass IIUnauthorised substance or claim
Truvy Boost 30-Day Experience Kit
Official wording (English):
The products contain DMHA and/or hordenine which FDA has determined are not acceptable dietary ingredients.
- May 31, 2023reportedFDAClass IIUnauthorised substance or claim
TruBoost 7 Day Experience Kit
Official wording (English):
The products contain DMHA and/or hordenine which FDA has determined are not acceptable dietary ingredients.
- May 31, 2023reportedFDAClass IIUnauthorised substance or claim
TruBoost Drink - Citrine Spark
Official wording (English):
The products contain DMHA and/or hordenine which FDA has determined are not acceptable dietary ingredients.
Sources: openFDA (U.S. FDA food enforcement reports), CC0 · Health Canada / CFIA Recalls and Safety Alerts, Open Government Licence – Canada · Food Standards Agency food alerts, OGL v3 · RappelConso (DGCCRF), Licence Ouverte 2.0. Shares and counts: Shelfpedia calculations.