The Recall Desk

Hazard

Infection Risk recalls

3,429 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
3,429
Critical
25
Severe
988
Most recent
2026-09-03

Of the 3,429 infection risk recalls we have scored against our rubric, 25 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 988 (29%) 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 infection risk 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.

876–900 of 3429

  • HighFDA (Drugs)·D-0423-2022·2022-02-02

    Betadine Sterile Ophthalmic Solution Recalled for Sterility Assurance

    Edge Pharma is recalling Betadine sterile ophthalmic solution syringes due to lack of assurance of sterility. The affected product is a preservative-free, single-use ophthalmic solution distributed nationwide.

    Product
    Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446, NDC 05446-1680-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0369-2022·2022-01-19

    Exela Sodium Bicarbonate Injection Recalled for Sterility Assurance Failure

    Exela Pharma Sciences is recalling 8.4% Sodium Bicarbonate Injection due to lack of assurance of sterility. The affected lot (C0001088/P0001317, expiring 08/2023) was distributed nationwide.

    Product
    8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0370-2022·2022-01-19

    Methylprednisolone Acetate Injectable Suspension Lacks Sterility Assurance

    Teva Pharmaceuticals is recalling Methylprednisolone Acetate Injectable Suspension 400 mg/10mL due to lack of assurance of sterility. The recall affects one lot distributed to facilities in Tennessee, Mississippi, and Ohio.

    Product
    MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 16714-090-01, packaged in cartons.
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0303-2022·2022-01-05

    SterRx Norepinephrine Injection Recalled Due to Sterility Assurance Concerns

    SterRx is recalling 9,360 bags of Norepinephrine 4 mg per 250 mL injection nationwide due to lack of assurance of sterility. The product is used in hospital and clinical settings to treat low blood pressure.

    Product
    NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-451-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0317-2022·2022-01-05

    SterRx Fentanyl Citrate Injection recalled for lack of sterility assurance

    SterRx is recalling Fentanyl Citrate in 0.9% Sodium Chloride Injection (2.5 mg per 250 mL) distributed nationwide due to lack of assurance of sterility.

    Product
    Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0325-2022·2022-01-05

    Sodium Bicarbonate in 5% Dextrose Injection Lacks Sterility Assurance

    SterRx is recalling 2,886 bags of Sodium Bicarbonate in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The affected product may pose a risk to patients who receive this intravenous medication.

    Product
    Sodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0311-2022·2022-01-05

    SterRx Epinephrine Injection Recalled for Lack of Sterility Assurance

    SterRx is recalling 684 bags of epinephrine in 0.9% sodium chloride injection nationwide due to lack of assurance of sterility. The product is supplied to hospitals and healthcare facilities.

    Product
    EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-627-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0304-2022·2022-01-05

    EPINEPHrine Injection Recall Due to Lack of Sterility Assurance

    SterRx is recalling EPINEPHrine 2 mg per 250 mL injectable solution nationwide due to lack of assurance of sterility. The recall affects 2,779 bags distributed across the U.S.

    Product
    EPINEPHrine, 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-027-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0312-2022·2022-01-05

    Midazolam Injection Recalled Due to Lack of Sterility Assurance

    SterRx is recalling Midazolam in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. The recall affects approximately 36,360 bags distributed across the United States.

    Product
    Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-102-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0320-2022·2022-01-05

    SterRx Norepinephrine Injection Recalled Due to Lack of Sterility Assurance

    SterRx is recalling 121,584 bags of Norepinephrine 4 mg per 250 mL injection nationwide due to lack of assurance of sterility. The drug is used to treat low blood pressure in critical care settings.

    Product
    NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-651-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0302-2022·2022-01-05

    dilTIAZem HCl Injection Recalled Due to Sterility Assurance Failure

    SterRx is recalling dilTIAZem HCl 125 mg per 125 mL injectable solution nationwide due to lack of assurance of sterility. The recall affects 24,300 bags distributed across the United States.

    Product
    dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-976-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0323-2022·2022-01-05

    SterRx Phenylephrine HCl Injection Recalled for Sterility Assurance

    SterRx is recalling PHENYLephrine HCl 40 mg per 250 mL injectable solution nationwide due to lack of assurance of sterility. The recall affects approximately 20,640 bags distributed across the United States.

    Product
    PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-252-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0318-2022·2022-01-05

    SterRx Morphine Sulfate Injection Recalled for Sterility Assurance

    SterRx is recalling 880 bags of Morphine Sulfate in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. Patients and healthcare providers should stop using affected units immediately.

    Product
    MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-427-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0319-2022·2022-01-05

    SterRx Norepinephrine Injection Recalled for Lack of Sterility Assurance

    SterRx is recalling 1,044 bags of Norepinephrine 16 mg per 250 mL in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The affected product carries NDC 70324-002-01 with lot code S21194/CDW.

    Product
    NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-002-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0301-2022·2022-01-05

    SterRx Morphine Sulfate Injection Recalled for Sterility Assurance

    SterRx is recalling Morphine Sulfate in 0.9% Sodium Chloride Injection (1 mg per mL) nationwide due to lack of assurance of sterility. The recall affects 880 units distributed across the United States.

    Product
    Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY, 12903, NDC 70324-427-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0321-2022·2022-01-05

    SterRx Norepinephrine 8 mg Sodium Chloride Injection Recalled

    SterRx, LLC is recalling 74,508 bags of Norepinephrine 8 mg per 250 mL in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. The FDA classified this as a Class II recall.

    Product
    NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-676-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0309-2022·2022-01-05

    Epinephrine Injection Recalled for Lack of Sterility Assurance

    SterRx is recalling epinephrine in 0.9% sodium chloride injection (5 mg per 250 mL) nationwide due to lack of assurance of sterility. Affected lots are identified by codes S21255/BXA, S21264/BXH, and S21328/BZO.

    Product
    EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-052-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0305-2022·2022-01-05

    Phenylephrine HCL Injection Recalled for Lack of Sterility Assurance

    SterRx is recalling approximately 18,948 bags of Phenylephrine HCL in 0.9% Sodium Chloride injection nationwide due to lack of assurance of sterility. The product is distributed across the U.S.A.

    Product
    PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-701-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0315-2022·2022-01-05

    dilTIAZem HCl in Dextrose Injection Recalled for Sterility Assurance

    SterRx is recalling dilTIAZem HCl in 5% Dextrose Injection due to lack of assurance of sterility. The recall affects 8,946 bags distributed nationwide.

    Product
    dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-951-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0308-2022·2022-01-05

    SterRx Epinephrine Injection Recalled for Lack of Sterility Assurance

    SterRx is recalling epinephrine in 0.9% sodium chloride injection (4 mg per 250 mL) nationwide due to lack of assurance of sterility. The recall affects 26,928 bags distributed across the United States.

    Product
    EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-227-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0307-2022·2022-01-05

    SterRx Succinylcholine Chloride Injection Recalled for Sterility Assurance

    SterRx is recalling Succinylcholine Chloride Injection 20 mg/mL vials (1,000 mL) distributed nationwide due to lack of assurance of sterility. The 3,540 affected bags may pose a risk to patients receiving this injectable drug.

    Product
    Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL, Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-826-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0411-2022·2021-12-29

    Newborn Kit Needles Recalled Due to Sterility Defect

    ROi CPS LLC is recalling regard Clinical Packaging Solutions Newborn Kits (Item 830096005) containing non-sterile needles. The kits were distributed to Missouri.

    Product
    regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0409-2022·2021-12-29

    Malosa Core SMILE Pack Medical Refractive Kit Recalled for Packaging Defect

    Beaver Visitec International is recalling the Malosa Core SMILE Pack 1-Medical Refractive Kit because packaging may contain small holes that compromise sterility. The recall affects 680 units distributed in nine states.

    Product
    Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0405-2022·2021-12-29

    Malosa Core LASIK Pack Recalled for Sterility-Compromising Packaging Defects

    Beaver Visitec International recalls 920 units of Malosa Core LASIK Pack due to packaging holes that may compromise product sterility. Compromised sterility creates infection risk in surgical use.

    Product
    Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK100/2
    Category
    Medical Device
    Distribution
    9 states