The firm distributes dietary supplements which contain Mitragyna speciosa (kratom) a dietary ingredient with inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Also, based on FDA sample positive sample results, the red and green strains are potentially contaminated with Salmonella.
Dietary Supplements
🍎 Food • 650 recalls
FDA inspection found two lots of supplements that did not declare shellfish as an ingredient on the product label; shellfish is properly declared on website.
Genestra brand AFA-gen capsule 15 mg Niacin/ capsule 300 mg Blue Green Algae / capsule 2 capsules, twice daily Dietary supplement 90 capsules, White 150cc HDPE Bottle with Desiccant and white cap, packed as 12 bottles / shipper case
Seroyal International, a division of Atrium Innovations
Microcystins level found to be above the specification limit of NMT1 ppm as per Raw Material Specification.
Prescript-Assist Broad Spectrum Probiotic & Prebiotic Gastrointestinal Support Dietary Supplement, 60-capsule or 90-capsule bottles; UPC Codes: 853956003157, 853956003539
LL'S MAGNETIC CLAY
The recalled dietary supplement has the potential to contain undeclared allergens, including almonds, shellfish, milk, eggs, and peanuts.
Sisel, SiselRipt, postWORKOUT, Dietary supplement, net wt 5g (0.17 oz), Internal Company Number F137315-10-01
Sisel International
Firm is recalling SiselRipt due to the presence of an unapproved artificial sweetener, Cyclamates.
Blood & Internal Cleanser, Dietary Supplement
Nutreglo Products
The product Blood & Internal Cleanser is a dietary supplement with drug claims and iron content at 67 & 69% of declared, per laboratory results. The product Belly Fat Reducer + Energy Booster and Stamina declares incorrect amount of Vitamin B6. The product label declares 50mg and only contains 0.1 mg as per laboratory results.
Belly Fat Reducer + Energy Booster and Stamina, Dietary Supplement
Nutreglo Products
The product Blood & Internal Cleanser is a dietary supplement with drug claims and iron content at 67 & 69% of declared, per laboratory results. The product Belly Fat Reducer + Energy Booster and Stamina declares incorrect amount of Vitamin B6. The product label declares 50mg and only contains 0.1 mg as per laboratory results.
The firm was informed that the product did not contain vitamin B12 (Methylcobalamyn) as listed on the label.
Nature's Only Choice B17 BITTER RAW APRICOT EXTRACT AMYGDALIN Dietary Supplement 100 Capsules
Nature's Only Choice
The Vitamin B17 containing product is considered to be a prescription drug, new drug, and unapproved new drug.
Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration.
Peaceful Mountain, Nasal Rescue, Dietary Supplement, Natural Sinus Support, Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579
Grato Holdings
Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration.
Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration.
Energique, Dietary Supplement, Enervimin CNCR Focus, Dist. by Energique Inc.. Woodbine, IA 51579
Grato Holdings
Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration.
Mitragyna Speciosa Leaf Powder Green Horn Kratom product is being recalled because they have the potential to be contaminated with Salmonella
Ignite High Endurance Pre-Workout Supplement with Caffeine dietary supplement product is recalled because label declared WHEY protein but do not declare milk.
Mitragyna Speciosa Leaf Powder Thai Maeng Da Kratom product is being recalled because they have the potential to be contaminated with Salmonella
Ignite High Endurance Pre-Workout Supplement VANILLA dietary supplement product is recalled because label declared WHEY protein but do not declare milk.
Per order of the Consent Decree, firm is recalling all dietary supplements.
Mitragyna Speciosa Leaf Powder Red Vein Sumatra and Mitragyna Speciosa Leaf Powder Red Vein Bali Kratom products are being recalled because they have the potential to be contaminated with Salmonella
Ignite High Endurance Pre-Workout Supplement dietary supplement product is recalled because label declared WHEY protein but do not declare milk.