The Recall Desk

Hazard

Quality Control Failure recalls

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

What the numbers show

Total
163
Critical
0
Severe
8
Most recent
2026-08-12

Of the 163 quality control failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 8 (5%) 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 quality control failure 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.

101–125 of 163

  • ModerateFDA (Drugs)·D-1341-2019·2019-06-19

    Chiesi Recalls ZYFLO CR Tablets Due to Dissolution Failure

    Chiesi USA is recalling ZYFLO CR (zileuton) extended-release tablets because they failed to meet dissolution specifications. The recall affects 2,118 bottles distributed nationwide.

    Product
    ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-902-12.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1253-2019·2019-05-08

    Carolina Liquid Chemistries Recalls Ethyl Alcohol Assay Kits

    Carolina Liquid Chemistries is recalling 20 Ethyl Alcohol Assay Kits because supplier testing showed the absorbance rate did not meet internal quality control specifications.

    Product
    CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Drugs)·D-0996-2019·2019-03-20

    Lannett Recalls Oxybutynin Chloride Tablets for Dissolution Failures

    Lannett Company Inc. is recalling 14,448 bottles of Oxybutynin Chloride Extended-Release Tablets because they failed to meet dissolution specifications.

    Product
    OXYBUTYNIN CHLORIDE — OXYBUTYNIN CHLORIDE (OXYBUTYNIN CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0381-2019·2019-01-23

    Teva Recalls Olmesartan Medoxomil and Hydrochlorothiazide Tablets for Dissolution Failure

    Teva Pharmaceuticals USA is recalling specific lots of Olmesartan Medoxomil and Hydrochlorothiazide Tablets because they failed to meet dissolution specifications.

    Product
    Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a) 30-count bottle (NDC 0093-7617-56), b) 90-count bottle (NDC 0093-7617-98), Rx only, Manufactured In Israel By: Teva Pharmaceutical, IND. LTD., Jerusalem, 9777402, Israel, Manufactured For: Teva Phar
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0249-2019·2018-10-31

    McCain Recalls Fire-Roasted Diced Tomatillos Due to Listeria and Salmonella Testing Issues

    McCain Foods USA is recalling Fire-Roasted 1/2" Diced Tomatillos because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire-Roasted 1/2" Diced Tomatillos; Sold in 25 lb. containers. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • LowFDA (Drugs)·D-0249-2019·2018-10-24

    Amerigen Recalls Temozolomide Capsules Due to Dissolution Failures

    Amerigen Pharmaceuticals is recalling Temozolomide capsules because stability testing revealed out-of-specification dissolution results.

    Product
    Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2994-2018·2018-09-19

    Diagnostica Stago Recalls STA N¿oplastine¿ CI Reagents Due to Quality Control Issues

    Diagnostica Stago is recalling STA N¿oplastine¿ CI in-vitro diagnostic kits because quality control values fell outside assigned ranges, potentially affecting prothrombin time test results.

    Product
    Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. REF: 00666 The STA¿ - N¿oplastine¿ CI kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿, STA Compact¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2410-2018·2018-07-18

    Ohio Medical Vacuum Regulator Recalled for Incomplete Quality Control Testing

    Ohio Medical Corporation is recalling 11 Vacuum Regulator units because final quality control testing was not completed before distribution.

    Product
    Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usage: The vacuum regulator is intended to be used in a medical facility as a means to evacuate media (i.e. fluids) from the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2140-2018·2018-06-20

    Immunalysis Recalls EDDP Urine Control Set Due to Specification Failure

    Immunalysis is recalling 37 kits of EDDP Urine Control Set 1 because the High control fails to meet specifications, potentially producing inaccurate test results.

    Product
    lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonolysis EDDP Specific Urine Enzyme Immunoassay, which has a cutoff of 100 ng/ml. This test provides only a preliminary analytical test result
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1804-2018·2018-05-23

    Beckman Coulter Recalls MicroScan MICroSTREP Plus Panel Due to QC Failures

    Beckman Coulter is recalling 523 boxes of MicroScan MICroSTREP Plus Panel and associated broth due to quality control testing failures.

    Product
    BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3% lysed horse blood, Catalog Number 81015 MicroScan Mueller Hinton Broth with 3% Lysed Horse Blood is used for inoculation of MicroScan MICroSTREP plus and MicroFAST panels. MICroSTREP plus p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1613-2018·2018-05-09

    Roche cobas b 221 AutoQC Module Recall for Software Failure

    Roche Diagnostics is recalling cobas b 221 AutoQC Modules because a software defect prevents the scheduled quality control measurements from starting.

    Product
    cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1611-2018·2018-05-09

    Roche OMNI S4 Analyzer Recalled for Software Scheduler Failure

    Roche Diagnostics is recalling 1,026 OMNI S4 analyzers because a software defect prevents the AutoQC scheduler from activating.

    Product
    Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1610-2018·2018-05-09

    Roche Omni S2 Analyzer Recall Due to Software Failure

    Roche Diagnostics is recalling 1,026 Omni S2 analyzers because a software defect prevents scheduled quality control measurements from starting.

    Product
    cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0264-2018·2017-12-27

    BioMerieux Recalls ETEST Oxacillin Strips Due to Quality Control Failures

    BioMerieux SA is recalling ETEST Oxacillin strips due to quality control failures that may cause false resistant results.

    Product
    ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0265-2018·2017-12-27

    BioMerieux Recalls ETEST OXACILLIN Strips Due to Quality Control Failures

    BioMerieux SA is recalling ETEST OXACILLIN OX 256 WW F100 in vitro diagnostic strips due to quality control failures that may cause false resistant results.

    Product
    ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0171-2018·2017-12-06

    BD Phoenix PMIC-107 Panels Recalled Due to Quality Control Failures

    Becton Dickinson is recalling specific lots of BD Phoenix PMIC-107 panels due to manufacturing issues that may affect antibiotic susceptibility testing results.

    Product
    BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171, (10)7031818(17)180228(30)0025, IVD. PMIC-107 is a Gram positive AST Only panel used to test antibiotic susceptibility. The inducible macrolide-linosamide-steptogramin B (iMLSb) resistance D-test screen for
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-0098-2018·2017-12-06

    Mayne Pharma Recalls Liothyronine Sodium Tablets for Dissolution Failures

    Mayne Pharma Inc is recalling 11,364 bottles of Liothyronine Sodium Tablets 25 mcg because they failed dissolution specifications. The affected lot is distributed nationwide.

    Product
    Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distributed by Perrigo Minneapolis, MN 55427, NDC 0574-0222-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3134-2017·2017-09-27

    BioMérieux Recalls VITEK 2 GP Cards Due to Quality Control Failures

    BioMérieux is recalling VITEK 2 GP ID cards because they are producing atypical negative reactions for a specific quality control strain, causing testing failures.

    Product
    VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes growt
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2867-2017·2017-08-09

    Sentinel CH Recalls MULTIGENT Creatinine Reagents Due to Quality Control Issues

    Sentinel CH SPA is recalling MULTIGENT Creatinine (Enzymatic) reagents because Reagent 1 may cause quality control values to shift out of acceptable range.

    Product
    MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems The product is a medical device (chemistry reagent) and is intended for the quan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0885-2017·2017-06-14

    Dr. Reddy's Recalls Zenatane Isotretinoin Capsules for Dissolution Failures

    Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) capsules because some lots failed to meet dissolution specifications, potentially affecting drug absorption.

    Product
    ZENATANE — ZENATANE (ISOTRETINOIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2316-2017·2017-06-14

    MedTest DX Assayed Human Multi Sera Control Recall for Out-of-Spec Values

    Medtest Holdings, Inc. is recalling MedTest DX Assayed Human Multi Sera Control Level 1 and Level 2 because control values are outside of specification.

    Product
    MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rubber stopper and black plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. HNC200 " Sml amber glass vials with rubber stopper and green p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0506-2017·2017-03-08

    Dr. Reddy's Recalls Zenatane Capsules for Dissolution Failure

    Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) capsules because they failed to meet dissolution specifications. The affected lot is distributed nationwide.

    Product
    ZENATANE — ZENATANE (ISOTRETINOIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1055-2017·2017-01-25

    Binding Site Digital RID Plate Reader Recalled for Software Defect

    The Binding Site Group is recalling Digital RID Plate Readers and software because a defect may prevent the system from flagging out-of-range quality control results.

    Product
    Digital RID Plate Reader and Software Product Code: AD400
    Category
    Medical Device
    Distribution
    11 states