The Recall Desk

Hazard

Unapproved Drug Product 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
2
Most recent
2025-06-25

Of the 2 unapproved drug product recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (100%) 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 product 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-0492-2025·2025-06-25

    UNAVY ACIDO HIALURONICO supplement recalled for undeclared pharmaceutical ingredients

    UNAVY ACIDO HIALURONICO hyaluronic acid supplement is being recalled because it contains three undeclared pharmaceutical ingredients: Dexamethasone, Diclofenac, and Omeprazole. The product was marketed without FDA approval and poses health risks from the unlisted drugs.

    Product
    UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7 503046 054295
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0463-2025·2025-06-18

    Dietary Supplement Male Ultra Recalled for Undeclared Drug Ingredients

    Male Ultra dietary supplement, distributed nationwide in 3,000 boxes, has been recalled because laboratory testing found it contains undeclared pharmaceutical ingredients: propoxyphenylsildenafil and sildenafil. The product was marketed without FDA approval.

    Product
    Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distributed By; Health Fixer, Tempe, AZ 85288, UPC B0CMQ4FTHG.
    Category
    Drug
    Distribution
    Distributed nationwide