The Recall Desk

Hazard

Failed Impurity Specification 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
0
Most recent
2022-01-12

Of the 2 failed impurity specification recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 failed impurity specification 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

  • ModerateFDA (Drugs)·D-0342-2022·2022-01-12

    MAJOR Fexofenadine Hydrochloride 60mg tablets recalled for failed impurity specifications

    Perrigo Company PLC is recalling MAJOR brand Fexofenadine Hydrochloride 12HR 60mg antihistamine tablets due to failed impurities and degradation specifications detected during stability testing.

    Product
    MAJOR, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Distributed by Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. Made in the Czech Republic, NDC 0904-6979-60 UPC 3 09046 97960 9
    Category
    Drug
    Distribution
    Distributed nationwide