The Recall Desk

Hazard

Unapproved Ingredient recalls

87 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
87
Critical
12
Severe
32
Most recent
2025-02-05

Of the 87 unapproved ingredient recalls we have scored against our rubric, 12 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 32 (37%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all unapproved ingredient recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–25 of 87

  • HighFDA (Food)·F-0455-2025·2025-02-05

    Alpha Test supplement capsules recalled for unapproved cathine ingredient

    Iovate Health Sciences is recalling Alpha Test 120-count capsules containing cathine, an unapproved ingredient not permitted in dietary supplements. Affected products were distributed across the United States and internationally.

    Product
    Alpha Test 120 count Black labeled plastic bottle, 12 bottles per case of 120 count capsules each per bottle, Store in a cool, dry place (60 F to 80 F), UPC 6-31656-60676-8, SKU0001191, SKU0002075
    Category
    Drug
    Distribution
    30 states
  • HighFDA (Food)·F-0948-2023·2023-05-31

    Truvy Boost Dietary Supplement Kit Recalled for Unapproved Ingredients

    TruVision Health LLC is recalling Truvy Boost 30-Day Experience Kit (Lot 13993) because it contains DMHA and/or hordenine, which FDA has determined are not acceptable dietary ingredients.

    Product
    Truvy Boost 30-Day Experience Kit
    Category
    Drug
    Distribution
    50 states
  • ModerateFDA (Food)·F-0704-2021·2021-06-30

    Dietary supplement Tight! Xtreme Reloaded recalled for unapproved ingredient

    SAN Corporation is recalling Tight! Xtreme Reloaded dietary supplement capsules because FDA inspection found an unapproved New Dietary Ingredient, Hordenine, in the product.

    Product
    Tight! Xtreme Reloaded: 120 count capsules (serving size 3 capsules) Ingredients: Evapor8 Total Body Fat Assault Matrix (Sulbutiamine, Caffeine Anhydrous, Beta-Phenethylamine, Hordeum Vulgare [Root] [Std. to 98% Hordenine], FucoPure [10% Fucoxanthin], Peganum Hamala Extract,
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0381-2021·2021-05-26

    FDA Recalls PremierZen Extreme 3000 for Unapproved Tadalafil

    Hyobin LLC is recalling PremierZen Extreme 3000 capsules because FDA analysis found the unapproved drug tadalafil. The product was marketed without an approved NDA or ANDA.

    Product
    PremierZen Extreme 3000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0382-2021·2021-05-26

    FDA Recalls PremierZen Black 5000 for Unapproved Tadalafil

    Hyobin LLC is recalling PremierZen Black 5000 capsules because FDA analysis detected the unapproved drug tadalafil. The product was marketed without an approved NDA or ANDA.

    Product
    PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0366-2021·2021-05-12

    Thumbs Up 7 Red 70K Recalled for Unapproved Sildenafil and Tadalafil

    Antoto-K is recalling Thumbs Up 7 Red 70K because FDA analysis found unapproved sildenafil and tadalafil. The product was marketed without an approved NDA or ANDA.

    Product
    Thumbs Up 7 Red 70K, 10 count blister pack cartons, Distributed by Ummzy LLC., Made in USA, UPC 6 17135 89467 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0369-2021·2021-05-12

    FDA Recalls PremierZen Extreme 3000 for Unapproved Active Ingredients

    QMart is recalling PremierZen Extreme 3000 capsules because FDA analysis found unapproved drugs tadalafil and/or sildenafil.

    Product
    PremierZen Extreme 3000, Male Sexual Performance Enhancement, 1 Capsule, UPC 728175421887
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0446-2021·2021-04-28

    Motha Jelly Crystals Recalled for Undeclared Dyes and Unapproved Colorant

    USA LANKA INC is recalling Motha Jelly Crystals because the product contains undeclared FD&C yellow #5 and blue #1, as well as the unapproved dye carmoisine.

    Product
    Motha Jelly Crystals - Mixed Fruit Flavoured Jelly, Net Wt. 100g,
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-0707-2020·2020-02-26

    Taspen's Organics Breathe Easy Herbal Tincture Recalled for Coltsfoot

    Green Water, LLC is recalling Taspen's Organics Breathe Easy Herbal Tincture because it contains Coltsfoot, which is not to be used internally.

    Product
    Taspen's Organics Breathe Easy Herbal Tincture Dietary Supplement, sold in 1 oz, 2 oz, and 4 oz amber glass bottles with dropper.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0656-2020·2020-01-22

    FDA Recalls Rhino 7 Platinum 30000 Capsules for Unapproved Tadafila Content

    Motto International Corp is recalling Rhino 7 Platinum 30000 Capsules because FDA analysis found the product contains tadalafil, an unapproved active ingredient.

    Product
    Rhino 7 Platinum 30000 Capsules, in blue,orange,black background with red,white,blue,gray text in hologram paper packaging, packaged in 2, 4, and 10 count blister cards, Motto International, Dallas, TX
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0655-2020·2020-01-22

    FDA Recalls Unapproved Stallion Platinum 30000 Capsules Containing Tadalafil

    Motto International Corp is recalling Stallion Platinum 30000 Capsules because FDA analysis found the unapproved product contains tadalafil.

    Product
    Stallion Platinum 30000 Capsules in blue,orange,white background with red,white text in hologram paper packaging, packaged in 2, 4, 10 count blister cards, Motto International, Dallas, TX
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0657-2020·2020-01-22

    FDA Recalls Panther Platinum 30000 Capsules for Unapproved Tadalfil Content

    Motto International Corp is recalling Panther Platinum 30000 Capsules because FDA analysis found the product contains tadalfil and was marketed without an approved NDA or ANDA.

    Product
    Panther Platinum 30000 Capsules, in green, black background with white, red text in hologram paper packaging, packaged in 2, 4, and 10 count blister cards, Motto International, Dallas, TX
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0843-2019·2019-02-13

    AdvoCare SleepWorks Liquid Supplement Recalled for Unapproved Ingredient

    AdvoCare International is recalling SleepWorks Liquid Vitamin & Mineral Herbal Supplement because it contains beta phenyl gamma aminobutyric acid HCl.

    Product
    SleepWorks Liquid Vitamin & Mineral Herbal Supplement 12 single serving bottles - 2 Fl Oz (60 mL) Net 24 Fl Oz (720 mL), product code W3721
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1983-2018·2018-10-03

    Zakah Life Recalls Kratom Supplements Due to Salmonella Contamination Risk

    Zakah Life LLC is recalling Super Green Maeng Da Premium Kratom supplements because FDA samples tested positive for Salmonella.

    Product
    Super Green Maeng Da Premium Kratom, Zakah Life Dietary Supplement, Mitragyn Speciosa, packaged in 1) 90 capsules, 500 mg per capsules bottles, or 2) 3.52 oz // 100 grams of Kratom bags. Distributed by Zakah Life LLC Ankeny IA.
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1074-2018·2018-08-15

    Teva Recalls Omega-3 Capsules Due to Unapproved Manufacturing Material

    Teva Pharmaceuticals is recalling 13,715 bottles of Omega-3-Acid Ethyl Esters Capsules because an API material used in manufacturing did not receive regulatory approval prior to release.

    Product
    Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured by: Banner Pharmacaps, Inc. High Point, NC 27265. Manufactured for: Teva Pharmaceuticals USA Inc. North Wales, PA 19454 NDC 0093-5401-89
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Food)·F-1605-2018·2018-07-11

    SNI Recalls Nitric Blast Pink Lemonade for DMAA Ingredient

    SNI, LLC is recalling Nitric Blast Pink Lemonade products containing geranium extract (DMAA) as a dietary ingredient.

    Product
    SNI Nitric Blast Pink Lemonade 276gr (UPC ending in 5598)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1020-2018·2018-04-25

    Divinity Kratom Capsules Recalled Due to Unapproved New Dietary Ingredient

    Divinity Product Distribution LLC is recalling kratom capsules because the ingredient lacks adequate safety information to ensure it does not present a significant risk of illness or injury.

    Product
    Kratom capsules labeled in the following ways: 1) Divinity Kratom 10 Capsule Dietary Supplement, Divinity Product LLC, Blue Springs, MO 64015; 2) Divinity Bali Kratom, 10PK Capsules; 3) Divinity Bali Kratom, 20PK Capsules; 4) Divinity Bali Kratom, 40PK Capsules;
    Category
    Food
    Distribution
    44 states
  • HighFDA (Food)·F-3601-2017·2017-10-11

    ProSupps DNPX Powder Recalled for Unapproved Ingredient Picamilon

    ProSupps USA LLC is recalling DNPX Powder, 30 Blue Razz, because it contains the unapproved ingredient picamilon. The product was distributed in the US and Canada.

    Product
    DNPX Powder, 30 Blue Razz
    Category
    Food
    Distribution
    0 states