The Recall Desk

Hazard

Unapproved Nda recalls

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

What the numbers show

Total
2
Critical
0
Severe
1
Most recent
2025-06-18

Of the 2 unapproved nda recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (50%) 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 nda 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.

1–2 of 2

  • SevereFDA (Drugs)·D-0466-2025·2025-06-18

    Dietary Supplement ULTRA ARMOR Recalled for Undeclared Drug Ingredients

    ULTRA ARMOR dietary supplement, distributed by Health Fixer, is recalled nationwide because it contains undeclared pharmaceutical ingredients propoxyphenylsildenafil and sildenafil. The product was marketed without FDA approval.

    Product
    ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distributed by Health Fixer, Tempe, AZ 85288, UPC B0CYJ7Y5H9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0558-2024·2024-06-26

    OSSOS-SANS tablets recalled: undeclared diclofenac and methocarbamol found

    OSSOS-SANS Reforzado tablets are being recalled because they contain undeclared active pharmaceutical ingredients—diclofenac and methocarbamol—and were marketed without FDA approval.

    Product
    OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 30-count bottle, DISTRIBUIDOR POR: Naturistas Especializados, Alce Blanco 180-A Fracc. Industrial, Edo. de Mexico C.P. 53370
    Category
    Drug
    Distribution
    Distributed nationwide