The Recall Desk

Hazard

Unapproved Drug Ingredients recalls

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

What the numbers show

Total
5
Critical
3
Severe
2
Most recent
2021-06-23

Of the 5 unapproved drug ingredients recalls we have scored against our rubric, 3 (60%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (40%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all unapproved drug ingredients 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.

1–5 of 5

  • SevereFDA (Drugs)·D-0628-2021·2021-06-23

    Imperia Elita Vitaccino Coffee Recalled for Unapproved Drug Ingredients

    Imperia Elita Vitaccino Coffee sachets are being recalled because they were marketed without FDA approval and contain pharmaceutical ingredients Sibutramine and Fluoxetine. All lots distributed nationwide are affected.

    Product
    Imperia Elita Vitaccino Coffee, 10 g sachets, 15 sachets per box, Global Beauty Technologies, Manufactured for: Imperia-Elita Ltd. & Co, KG D- 35435 Wettenberg
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1087-2017·2017-08-23

    Biotech Underground Tri-Ton Hardcore Formula Recalled for Unapproved Ingredients

    Dynamic Technical Formulations is recalling Biotech Underground Tri-Ton Hardcore Formula capsules because FDA testing found unapproved drug ingredients.

    Product
    Biotech Underground Tri-Ton Hardcore Formula capsules, 90-count bottle, Distributed by: Dynamic Technical Formulations 12850 Hwy 9 Suite 600-441 Alpharetta, GA 30004
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0472-2017·2017-02-22

    MS Bionic Recalls MegaJex Herbal Supplement Containing Unapproved ED Drugs

    MS Bionic is recalling MegaJex Herbal Supplement because it contains sildenafil and tadalafil, active ingredients in approved erectile dysfunction drugs, without FDA approval.

    Product
    MegaJex Herbal Supplement, Maximum Formula for Men, Fast acting, Increase Stamina, 20 capsules, MS Bionics, Gardena, CA
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-1237-2014·2014-04-23

    FDA Recalls Virilis Pro Dietary Supplement for Unapproved Drug Ingredients

    Haute Health is recalling Virilis Pro dietary supplements because they may contain unapproved active ingredients found in FDA-approved erectile dysfunction drugs.

    Product
    Virilis Pro, 450mg/capsule, Packaged in a 1 and 2 capsule blister packs and 10 capsule bottles, Manufactured for Haute Health Williamstown, NJ 08094 website: http://www.virilispro.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-372-2014·2013-12-25

    Bethel Advance capsules recalled for unapproved drug ingredients

    Bethel Nutritional Consulting is recalling Bethel Advance capsules because FDA analysis detected unapproved drug ingredients, including phenolphthalein and sibutramine.

    Product
    Bethel Advance (bitter orange, mulberry leaf, cassia seed extract, jobstear seed, spirulina, starch, kola nut) capsules, 400 mg, 30-count bottles, Distributed by: Bethel, Inc., Tel: (212) 568-5330, UPC 1 60126 41750 9.
    Category
    Drug
    Distribution
    Distributed nationwide