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.

4001–4025 of 4878

  • SevereFDA (Food)·F-0610-2022·2022-02-02

    Twisted Chopped Greek Caesar Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Twisted Chopped Greek Caesar salad in 9.3oz packages due to potential Listeria monocytogenes contamination. The product was distributed to retailers in 20 U.S. states and Canada.

    Product
    "Twisted Chopped Greek Caesar" (salad product) packed in 9.3oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0408-2022·2022-02-02

    Mitomycin-C Sterile Ophthalmic Solution Lacks Sterility Assurance

    Edge Pharma is recalling Mitomycin-C Sterile Ophthalmic Solution because the manufacturer cannot assure that the product is sterile. The recall affects 163 syringes distributed nationwide.

    Product
    Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg/mL) 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1009-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0427-2022·2022-02-02

    Vancomycin HCl IV Injection Recalled Due to Sterility Assurance Concerns

    Edge Pharma is recalling Vancomycin HCl in 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The recall affects approximately 749 bags distributed nationwide.

    Product
    Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446 NDC 05446-1459-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0523-2022·2022-02-02

    5-Lettuce Mix Salad Recalled for Potential Listeria Contamination

    Fresh Express's 5-Lettuce Mix salad (6oz packages, code Z324-Z350) is recalled due to potential Listeria monocytogenes contamination. The product was distributed to over 110 domestic and 3 international distributors.

    Product
    "5- Lettuce Mix" (salad product) packed in 6oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0524-2022·2022-02-02

    American Salad Product Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling American-brand salad products in 11oz. and 24oz. packages due to potential Listeria monocytogenes contamination. Products were distributed across 20 U.S. states and Canada.

    Product
    "American" (salad product) packed in 11oz. and 24oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0398-2022·2022-02-02

    Cefuroxime Sterile Ophthalmic Injection Recalled Due to Sterility Concerns

    Edge Pharma is recalling Cefuroxime sterile ophthalmic solution for injection because the company cannot assure the product meets sterility requirements. The recall affects approximately 1,720 syringes distributed nationwide.

    Product
    Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0.3 mL single use syringe for Intraocular Injection, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446 NDC 05446-1003-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0576-2022·2022-02-02

    Fresh Express Organic Baby Spinach & Kale Mix Recall: Listeria Risk

    Fresh Express Inc is recalling "Organic Baby Spinach & Baby Kale Mix" salad in 5oz packages due to potential contamination with Listeria monocytogenes. The affected product was distributed to over 110 domestic distributors across multiple states and Canada.

    Product
    "Organic Baby Spinach & Baby Kale Mix" (salad product) packed in 5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0540-2022·2022-02-02

    Fresh Express Chopped Avocado Ranch salad recalled for Listeria risk

    Fresh Express is recalling 'Chopped Avocado Ranch' salad (codes Z324-Z350) due to potential Listeria monocytogenes contamination. Affected packages in 12.3oz, 12.8oz, and 13.2oz sizes were distributed across 20 states and Canada.

    Product
    "Chopped Avocado Ranch" (salad product) packed in 12.3oz., 12.8oz., and 13.2oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0415-2022·2022-02-02

    Edge Pharma Phenylephrine HCl Syringes Recalled for Sterility Assurance

    Edge Pharma, LLC is recalling Phenylephrine HCl 0.5 mg/5mL single-use syringes for intravenous injection nationwide due to lack of assurance of sterility. The affected product was distributed between September 2021 and January 2022.

    Product
    Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1545-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0543-2022·2022-02-02

    Chopped Cherry Almond Gorgonzola Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Chopped Cherry Almond Gorgonzola salad products (13.7 oz packages, codes Z324-Z350) due to potential Listeria monocytogenes contamination. The salad was distributed across 20 U.S. states and Canada.

    Product
    "Chopped Cherry Almond Gorgonzola" (salad product) packed in 13.7oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0595-2022·2022-02-02

    Fresh Express Shredded Lettuce Recall Due to Listeria Contamination Risk

    Fresh Express Inc is recalling shredded lettuce products in multiple package sizes due to potential Listeria monocytogenes contamination. The recall affects approximately 211,228 cases distributed across 20 U.S. states and Canada.

    Product
    "Shredded Lettuce" (salad product) packed in 8oz., 14oz., 16oz., and 5lb. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0599-2022·2022-02-02

    Spinach & Bacon Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling 14,832 cases of "Spinach & Bacon" salad in 10.2oz. packages due to potential Listeria monocytogenes contamination. The product was distributed to domestic and Canadian retailers.

    Product
    "Spinach & Bacon" (salad product) packed in 10.2oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0425-2022·2022-02-02

    Vancomycin HCl Injection Recall for Lack of Sterility Assurance

    Edge Pharma, LLC is recalling Vancomycin HCl in 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The 1,250 mg/250 mL pre-filled bags were distributed nationwide and may pose a safety risk if used.

    Product
    Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single Use Bag for IV Injection (Preservative Free), 250 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1456-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0571-2022·2022-02-02

    Organic Baby Arugula Recalled for Potential Listeria Contamination

    Fresh Express Inc is recalling Organic Baby Arugula in 5oz. and 16oz. packages due to potential contamination with Listeria monocytogenes. The product was distributed across multiple U.S. states and Canada.

    Product
    "Organic Baby Arugula" (salad product) packed in 5oz. and 16oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0591-2022·2022-02-02

    Roma Sliced Salad Recalled for Potential Listeria Contamination

    Fresh Express Inc is recalling Roma Sliced salad products in 1.5lb. packages due to potential contamination with Listeria monocytogenes. The affected products were distributed to domestic and Canadian distributors.

    Product
    "Roma Sliced" (salad product) packed in 1.5lb. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0594-2022·2022-02-02

    Santa Fe Bowl salad product recalled for potential Listeria contamination

    Fresh Express Inc is recalling Santa Fe Bowl salad in 5.23oz and 5.7oz packages due to potential Listeria monocytogenes contamination. The product was distributed to over 100 U.S. distributors and Canada.

    Product
    "Santa Fe Bowl" (salad product) packed in 5.23oz. and 5.7oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0546-2022·2022-02-02

    Fresh Express Chopped Kale Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling 3,277 cases of Chopped Kale Pecan Cranberry salad (9.5oz packages, codes Z324–Z350) due to potential Listeria monocytogenes contamination. The product was distributed to domestic and Canadian distributors.

    Product
    "Chopped Kale Pecan Cranberry" (salad product) packed in 9.5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0426-2022·2022-02-02

    Vancomycin HCl Injection Recalled for Sterility Assurance Issues

    Edge Pharma LLC is recalling Vancomycin HCl in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. The affected product is a 500 mL pre-filled bag for IV injection.

    Product
    Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1458-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0573-2022·2022-02-02

    Organic Baby Kale Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Organic Baby Kale salad in 5oz. packages due to potential Listeria monocytogenes contamination. The affected product was distributed across the United States and Canada.

    Product
    "Organic Baby Kale" (salad product) packed in 5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0601-2022·2022-02-02

    Fresh Express Spring Mix & Spinach Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling "Spring Mix & Spinach" salad products in 5oz. and 10oz. packages due to potential contamination with Listeria monocytogenes. The recall affects approximately 25,914 cases distributed to multiple U.S. states and Canada.

    Product
    "Spring Mix & Spinach" (salad product) packed in 5oz. and 10oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0550-2022·2022-02-02

    Fresh Express Chopped Southwest Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Chopped Southwest salad in 10.3oz packages due to potential Listeria monocytogenes contamination. The recall affects 40,867 cases distributed to domestic and Canadian distributors.

    Product
    "Chopped Southwest" (salad product) packed in 10.3oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0562-2022·2022-02-02

    Hearts of Romaine Salad Recalled for Listeria Contamination

    Fresh Express Inc is recalling Hearts of Romaine salad in 9oz., 10oz., and 18oz. packages due to potential contamination with Listeria monocytogenes. The affected products were distributed to multiple states and Canada.

    Product
    "Hearts of Romaine" (salad product) packed in 9oz., 10oz., and 18oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0612-2022·2022-02-02

    Fresh Express Veggie Spring Mix Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Veggie Spring Mix salad in 7oz. packages due to potential contamination with Listeria monocytogenes. The product was distributed to multiple states and Canada.

    Product
    "Veggie Spring Mix" (salad product) packed in 7oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0533-2022·2022-02-02

    Fresh Express Caesar Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Caesar salad products in multiple package sizes due to potential contamination with Listeria monocytogenes. The recall affects approximately 99,102 cases distributed across the United States and Canada.

    Product
    "Caesar" (salad product) packed in 9.8oz., 10.5oz., 11.3oz., 14.5oz., 19.5oz., and 22.3oz. packages
    Category
    Food
    Distribution
    20 states