The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

4026–4050 of 4878

  • SevereFDA (Drugs)·D-0411-2022·2022-02-02

    Neostigmine Methylsulfate Injectable Syringes Recalled for Sterility Assurance

    Edge Pharma, LLC is recalling Neostigmine methylsulfate 5 mg/5mL single-use syringes for IV or IM injection due to lack of assurance of sterility. Approximately 160 syringes nationwide may be affected.

    Product
    Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use Syringe for IV or IM Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1549-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0410-2022·2022-02-02

    Moxifloxacin Ophthalmic Injection Syringes Recalled for Sterility Risk

    Edge Pharma is recalling Moxifloxacin sterile ophthalmic injection syringes nationwide due to lack of assurance of sterility. The 860 affected syringes were distributed across two lots.

    Product
    Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL (1mg/mL), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LL, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1050-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0577-2022·2022-02-02

    Organic Caesar Salad Recalled for Potential Listeria Contamination

    Fresh Express Inc is recalling 9.8oz packages of Organic Caesar salad due to potential contamination with Listeria monocytogenes. The product was distributed to 110 domestic and 3 foreign distributors.

    Product
    "Organic Caesar" (salad product) packed in 9.8oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0578-2022·2022-02-02

    Organic Chopped Kale Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Organic Chopped Kale in 12oz packages due to potential contamination with Listeria monocytogenes. The affected product was distributed to wholesalers across the US and Canada.

    Product
    "Organic Chopped Kale" (salad product) packed in 12oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0545-2022·2022-02-02

    Fresh Express Chopped Kale Recall for Listeria Contamination Risk

    Fresh Express Inc is recalling Chopped Kale salad products in 11.9oz. and 12.2oz. packages due to potential Listeria monocytogenes contamination. The recall affects products distributed across multiple U.S. states and Canada.

    Product
    "Chopped Kale" (salad product) packed in 11.9oz. and 12.2oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0450-2022·2022-02-02

    Pioglitazone Tablets Recalled for Superpotent and Failed Specifications

    Aurobindo Pharma USA Inc. is recalling 792 bottles of Pioglitazone 45 mg tablets distributed nationwide due to superpotent tablets and tablets that fail to meet specifications.

    Product
    PIOGLITAZONE — PIOGLITAZONE (PIOGLITAZONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0598-2022·2022-02-02

    Fresh Express Spinach & Arugula Salad Recall for Listeria Contamination

    Fresh Express Inc is recalling 2,519 cases of 5oz. Spinach & Arugula salad packages due to potential Listeria monocytogenes contamination. The products were distributed across multiple U.S. states and Canada.

    Product
    "Spinach & Arugula" (salad product) packed in 5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0536-2022·2022-02-02

    Caesar Supreme Salad Recalled for Potential Listeria Contamination

    Fresh Express Inc is recalling Caesar Supreme salad products in 10.5oz packages due to potential contamination with Listeria monocytogenes. The recall affects 41,544 cases distributed to retailers and distributors across multiple states and Canada.

    Product
    "Caesar Supreme" (salad product) packed in 10.5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0584-2022·2022-02-02

    Organic Spring Mix Salad Recalled Due to Listeria Contamination Risk

    Fresh Express Inc is recalling Organic Spring Mix salad in 5oz., 10oz., and 16oz. packages due to potential Listeria monocytogenes contamination. Affected products were distributed to retailers and distributors across 20 US states and Canada.

    Product
    "Organic Spring Mix" (salad product) packed in 5oz., 10oz., and 16oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0401-2022·2022-02-02

    Edge Pharma Edetate Disodium Ophthalmic Solution Recall for Sterility Concerns

    Edge Pharma is recalling Edetate Disodium (EDTA) 3% Sterile Ophthalmic Solution due to lack of assurance of sterility. The product is a single-dose eye drop used for topical ophthalmic use.

    Product
    Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1428-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0534-2022·2022-02-02

    Fresh Express Caesar Bacon Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Caesar Bacon salad products (9.9oz., 10.3oz., and 14.6oz. packages) due to potential Listeria monocytogenes contamination. The affected products were distributed to domestic and Canadian wholesalers.

    Product
    "Caesar Bacon" (salad product) packed in 9.9oz., 10.3oz., and 14.6oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0549-2022·2022-02-02

    Fresh Express Chopped Pomegranate Salad Recalled for Listeria

    Fresh Express Inc is recalling Chopped Pomegranate salad in 10.3 oz packages due to potential Listeria monocytogenes contamination. The product was distributed to retailers and distributors across 20 U.S. states and Canada.

    Product
    "Chopped Pomegranate" (salad product) packed in 10.3oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0555-2022·2022-02-02

    Fresh Express Cranberry Walnut Bowl Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Cranberry Walnut Bowl salad products (4.5oz packages, codes Z324-Z350) due to potential Listeria monocytogenes contamination. The affected products were distributed to domestic and Canadian distributors.

    Product
    "Cranberry Walnut Bowl" (salad product) packed in 4.5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0602-2022·2022-02-02

    Sweet & Crunchy Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Sweet & Crunchy salad in 5oz. packages due to potential Listeria monocytogenes contamination. The affected products were distributed to food service distributors across 20 U.S. states and Canada.

    Product
    "Sweet & Crunchy" (salad product) packed in 5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0582-2022·2022-02-02

    Organic Lettuce Blend Recall Due to Listeria Contamination Risk

    Fresh Express Inc is recalling Organic Lettuce Blend in 16oz packages due to potential Listeria monocytogenes contamination. The product was distributed to 110 domestic and 3 foreign distributors across multiple states and Canada.

    Product
    "Organic Lettuce Blend" (salad product) packed in 16oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0404-2022·2022-02-02

    Lidocaine HCL / Bupivacaine HCL Sterile Ophthalmic Solution Lacks Sterility Assurance

    Edge Pharma is recalling a sterile ophthalmic injectable solution because the manufacturer cannot guarantee that the product remains sterile. The recall affects approximately 1,202 syringes distributed nationwide.

    Product
    Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic Solution for Injection (PF), 2%/0.375%, 8 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1548-18
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0622-2022·2022-02-02

    NutriCrafters MCT Powder Recalled Due to Supplier Recall

    NutriCrafters LLC is recalling Nutricrafters MCT Instant Coconut Milk Mixer (1 lb. bottles) because the medium chain triglyceride powder was repacked and distributed from a supplier product that is itself under recall.

    Product
    Nutricrafters MCT - Instant coconut milk mixer; 1 lb. (454 grams) Ingredients: Medium chain triglycerides, tapioca starch. Allergy information : contains oils from tree nuts (coconut) Suggested use: Stir into drinks or spoon over foods. Start with 1 teaspoon, preferably w
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0559-2022·2022-02-02

    Fresh Express Garden Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling its "Garden" salad product in 12oz., 24oz., and 3lb. packages due to potential Listeria monocytogenes contamination. The recall affects approximately 181,969 cases distributed across 20 U.S. states and Canada.

    Product
    "Garden" (salad product) packed in 12oz., 24oz., and 3lb. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0399-2022·2022-02-02

    Dexamethasone Sodium Phosphate Otic Injection Syringes Recalled for Lack of Sterility Assurance

    Edge Pharma LLC is recalling Dexamethasone sodium phosphate sterile otic solution for injection syringes (NDC 05446-0848-01) due to lack of assurance of sterility. Approximately 323 syringes were distributed nationwide.

    Product
    Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL (24mg/mL), 0.8 mL per syringe Single Use Syringe For Otic Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0848-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0414-2022·2022-02-02

    Eye Drops Recalled for Lack of Sterility Assurance by Edge Pharma

    Edge Pharma is recalling a multi-ingredient sterile ophthalmic solution nationwide due to lack of assured sterility. The product is used for topical eye application.

    Product
    Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution, 10%/1%/0.3%/0.125%, 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1270-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0607-2022·2022-02-02

    Fresh Express Twisted Avocado Caesar Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Twisted Avocado Caesar salad in 9.7oz. packages due to potential Listeria monocytogenes contamination. The product was distributed to retailers across 20 U.S. states and Canada.

    Product
    "Twisted Avocado Caesar" (salad product) packed in 9.7oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0554-2022·2022-02-02

    Fresh Express Coleslaw Recalled for Potential Listeria Contamination

    Fresh Express Inc is recalling coleslaw products in 14oz., 16oz., and 24oz. packages due to potential contamination with Listeria monocytogenes. The recall affects 46,083 cases distributed across 20 U.S. states and Canada.

    Product
    "Coleslaw" (salad product) packed in 14oz., 16oz, and 24oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0416-2022·2022-02-02

    Edge Pharma Phenylephrine HCl IV Injection Sterility Assurance Recall

    Edge Pharma is recalling Phenylephrine HCl 1mg/10mL single-use syringes for IV injection due to lack of assurance of sterility. The recall affects 6,535 vials distributed nationwide.

    Product
    Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446 NDC 05446-1544-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0493-2022·2022-02-02

    Trilogy Evo Ventilator Recalled for Foam Degradation Risk

    Philips Respironics recalls 473 Trilogy Evo ventilators due to non-conforming foam that may degrade and release particles. Affected patients risk inhaling or ingesting foam particles and chemicals during device use.

    Product
    Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adul
    Category
    Medical Device
    Distribution
    17 states