The Recall Desk

Hazard

Formulation Deviation 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
0
Severe
0
Most recent
2025-12-24

Of the 5 formulation deviation 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 formulation deviation 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

  • ModerateFDA (Devices)·Z-0938-2026·2025-12-24

    Clotting time reagent recalled after lots were made with double preservative

    Instrumentation Laboratory is recalling 4,506 units of HemosIL SynthAFax partial thromboplastin time reagent because the recalled lots were manufactured with double the preservative concentration.

    Product
    HemosIL SynthAFax. Partial Thromboplastin Time Tests.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0499-2015·2014-12-10

    Amerx Health Care Recalls Amerigel Daily Dressing Packets Due to Formulation Deviation

    Amerx Health Care Corp. is recalling 1,740 units of Amerigel Daily Dressing Packets due to a formulation deviation. The affected products were distributed nationwide and internationally.

    Product
    Amerigel Daily Dressing Packets Wound management
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0500-2015·2014-12-10

    Amerx Recalls Amerigel Saturated Gauze Dressing Due to Formulation Deviation

    Amerx Health Care Corp. is recalling 21,108 units of Amerigel Saturated Gauze Dressing due to a formulation deviation. The products were distributed nationwide and internationally.

    Product
    Amerigel Saturated Gauze Dressing Wound management
    Category
    Medical Device
    Distribution
    Distributed nationwide