The Recall Desk

Hazard

Concentration Error recalls

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

What the numbers show

Total
7
Critical
0
Severe
1
Most recent
2025-10-29

Of the 7 concentration error 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 (14%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all concentration error 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.

1–7 of 7

  • HighFDA (Devices)·Z-0234-2026·2025-10-29

    Prefilled saline flush syringes recalled over sodium chloride concentration shortfall

    Medline is recalling 8,267,150 Excelsior Medical 0.9% Sodium Chloride prefilled flush syringes because a limited quantity may not meet the required concentration of sodium chloride.

    Product
    Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1544-2022·2022-10-05

    Oxytocin injection recalled for incorrect sodium chloride concentration

    QuVa Pharma is recalling oxytocin injections due to incorrect formulation. Bags contain 0.45% sodium chloride instead of the intended 0.9%.

    Product
    oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This is a Compounded Product for Institutional or Office Use Only, Not for Resale, QuVa PHARMA 519 Route 173, Bloomsbury, NJ 08804, Total volume: 500 mL bag, NDC: 70092-1068-
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1336-2022·2022-07-13

    Medical Laboratory Control Material Recalled for Insufficient Glycine Concentration

    Chromsystems is recalling MassCheck Amino Acid Acylcarnitines dried blood spot control material due to too-low glycine concentration in batch 2821. The defect was found in units distributed to New York, Ohio, and Connecticut.

    Product
    MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1337-2022·2022-07-13

    Laboratory Control Material Recalled for Insufficient Glycine Concentration

    Chromsystems has recalled MassCheck Amino Acid, Acylcarnitines dried blood controls (batch 2821) for insufficient glycine concentration. This may affect laboratory test accuracy.

    Product
    MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0288-2022·2021-12-29

    Moxifloxacin 1 mg/mL Solution Label Mix-up Recall

    Denver Solutions, LLC (doing business as Leiters Health) is recalling Moxifloxacin 1 mg/mL intracameral injection solution because vials labeled as 1 mg/mL may actually contain 5 mg/mL, creating a serious dosing error risk.

    Product
    Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Compark Blvd, Englewood, CO 80112, (800) 292-6772, NDC 71449-096-42
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1010-2018·2018-03-21

    Fresenius NaturaLyte Liquid Acid Concentrate Recalled for Potassium Concentration Error

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid Concentrate because some units in the affected lot had a potassium concentration of 2.25 mEq/L instead of the labeled 2.0 mEq/L.

    Product
    NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialy
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0430-2013·2012-11-28

    Biomerieux Recalls 0.9% Sodium Chloride Injections for VITEK 2 System Use

    Biomerieux Inc is recalling 0.9% Sodium Chloride Injections that were distributed as 0.45% Sodium Chloride Saline bags for use with the VITEK 2 system.

    Product
    0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: The concentrated sodium chloride is used to prepare inoculum that is analyzed by the VITEK 2 instrument. The VITEK 2 user manual instructs all users to prepare inoculum with 0.45%-0.50% sodium chloride in
    Category
    Medical Device
    Distribution
    Distributed nationwide