The Recall Desk

Hazard

Out Of Specification recalls

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

About this hazard tag

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

51–75 of 164

  • HighFDA (Devices)·Z-1817-2026·2026-04-22

    Cytal Wound Matrix recalled over out-of-specification endotoxin test results

    Cytal Wound Matrix 2-Layer 7x10 cm dressings are being recalled because of an increased rate of out-of-specification endotoxin results. 46 units are affected.

    Product
    Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1819-2026·2026-04-22

    Cytal Burn Matrix recalled over out-of-specification endotoxin test results

    Cytal Burn Matrix 7x10 cm wound dressings are being recalled because of an increased rate of out-of-specification endotoxin results. Seven units are affected.

    Product
    Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0487-2026·2026-04-22

    Skin Script blemish spot treatment recalled for failing stability specifications

    Skin Script Blemish Spot Treatment containing 1% salicylic acid is being recalled after it failed stability specifications. The action covers 28,163 bottles.

    Product
    Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1816-2026·2026-04-22

    Cytal Wound Matrix 5x5 cm recalled over out-of-specification endotoxin results

    Cytal Wound Matrix 2-Layer 5x5 cm dressings are being recalled because of an increased rate of out-of-specification endotoxin results. 148 units are affected.

    Product
    Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1818-2026·2026-04-22

    Cytal Wound Matrix 10x15 cm recalled over out-of-specification endotoxin results

    Cytal Wound Matrix 2-Layer 10x15 cm dressings are being recalled because of an increased rate of out-of-specification endotoxin results. 452 units are affected.

    Product
    Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0476-2026·2026-04-22

    Taro fluocinonide cream 30 g tubes fail viscosity stability specifications

    Taro is recalling one lot of Fluocinonide 0.05% Cream in 30 g tubes after stability testing returned viscosity results above the specification limit. 41,712 tubes are affected.

    Product
    FLUOCINONIDE — FLUOCINONIDE (FLUOCINONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0477-2026·2026-04-22

    Taro fluocinonide cream 60 g tubes fail viscosity stability specifications

    Taro is recalling one lot of Fluocinonide 0.05% Cream in 60 g tubes after stability testing returned viscosity results above the specification limit. 2,640 tubes are affected.

    Product
    FLUOCINONIDE — FLUOCINONIDE (FLUOCINONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0408-2026·2026-04-08

    Amneal tramadol tablets failed nitrosamine impurity specification at stability

    Amneal Pharmaceuticals is recalling two lots of Tramadol Hydrochloride Tablets 50 mg after a nitrosamine impurity was found out of specification at the 24-month stability interval.

    Product
    TRAMADOL HYDROCHLORIDE — TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1629-2026·2026-04-01

    Orthalign drill plate sizes 1-5 may allow excessive bone cut

    Orthalign is recalling one lot of the Trimax Pegged Drill Plate sizes 1-5 for the Lantern Knee System because plates manufactured out of specification can result in a bone cut in excess of 0.0800 inches.

    Product
    Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1630-2026·2026-04-01

    Orthalign knee drill plates may allow a bone cut exceeding specification

    Orthalign is recalling one lot of the Trimax Pegged Drill Plate for the Lantern Knee System because plates manufactured out of specification can result in a bone cut in excess of 0.0800 inches.

    Product
    Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0398-2026·2026-03-25

    Dexamethasone injection failed impurity specifications at product expiry testing

    Somerset Therapeutics is recalling one lot of Dexamethasone Sodium Phosphate Injection after out-of-specification impurity results at product expiry during long term stability testing.

    Product
    DEXAMETHASONE SODIUM PHOSPHATE — DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1485-2026·2026-03-11

    Aesculap MINOP trocar shafts may be longer than specified

    Aesculap is recalling MINOP Trocar 150 mm with 6.0 mm working channel, model FF399R, because of the potential for the trocar shaft to be too long.

    Product
    Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product Description: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2188-2025·2025-08-06

    LIFEPEARL microspheres are smaller than specification, risking non-targeted embolization

    LIFEPEARL Drug Elutable Microspheres are being recalled because their actual average diameter is smaller than specification, which may lead to non-targeted embolization. 1,451 units affected.

    Product
    LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0537-2025·2025-07-30

    Clomipramine capsules failed a degradation product specification at expiry testing

    Clomipramine Hydrochloride Capsules USP 25 mg are being recalled after an out of specification result for an unspecified degradation product during retention sample testing at expiry. 2,724 bottles affected.

    Product
    CLOMIPRAMINE HYDROCHLORIDE — CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE CAPSULES)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0523-2025·2025-07-23

    Levothyroxine sodium 150 microgram tablets assayed below the approved specification

    Levothyroxine Sodium Tablets, USP 150 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 4,921 bottles affected.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide