The Recall Desk

Hazard

Safety Efficacy Unestablished 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
1
Severe
1
Most recent
2018-02-07

Of the 2 safety efficacy unestablished recalls we have scored against our rubric, 1 (50%) 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 safety efficacy unestablished 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-0568-2018·2018-02-07

    FDA Recalls Unapproved Power V8 Viagra Tablets Containing Sildenafil

    A&H Focal Inc. is recalling Power V8 Viagra tablets because they contain sildenafil, an unapproved drug with unestablished safety and efficacy.

    Product
    Power V8 Viagra tablets, 200mg, 10-Grain bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-0494-2017·2017-03-08

    Jeffreys Drug Store Recalls Compounded Domperidone Capsules 10 mg

    Jeffreys Drug Store is recalling compounded Domperidone capsules 10 mg because the product was marketed without an approved NDA/ANDA, meaning safety and efficacy have not been established.

    Product
    Domperidone capsules 10 mg, compounded, dispensed in 60, 90, and 360 count bottles, Jeffreys Drug Store 1 North Central Ave. Canonsburg, PA
    Category
    Drug
    Distribution
    1 state