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.

7101–7125 of 29119

  • SevereFDA (Food)·F-0579-2022·2022-02-02

    Organic Fresh Herb Mix Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Organic Fresh Herb Mix in 5oz packages due to potential contamination with Listeria monocytogenes. The product was distributed to wholesalers across 20 US states and Canada.

    Product
    "Organic Fresh Herb Mix" (salad product) packed in 5oz. 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-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-0556-2022·2022-02-02

    Crisp Greens Salad Recalled for Potential Listeria Monocytogenes Contamination

    Fresh Express Inc is recalling Crisp Greens salad in 12oz. packages due to potential contamination with Listeria monocytogenes. The recall affects products distributed to domestic and Canadian distributors across 20 U.S. states.

    Product
    "Crisp Greens" (salad product) packed in 12oz. 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-0542-2022·2022-02-02

    Fresh Express Chopped Caesar Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling "Chopped Caesar" salad in 9.4oz., 10.4oz., and 10.5oz. packages due to potential Listeria monocytogenes contamination. The product was distributed to domestic and Canadian distributors.

    Product
    "Chopped Caesar" (salad product) packed in 9.4oz., 10.4oz., and 10.5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0574-2022·2022-02-02

    Organic Baby Romaine Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling 1,105 cases of Organic Baby Romaine salad due to potential Listeria monocytogenes contamination. The product was distributed across 20 states and Canada.

    Product
    "Organic Baby Romaine" (salad product) packed in 5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0553-2022·2022-02-02

    Fresh Express Chopped Sweet Kale Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling approximately 27,047 cases of Chopped Sweet Kale salad due to potential contamination with Listeria monocytogenes. The affected 10.9oz packages were distributed across multiple states and Canada.

    Product
    "Chopped Sweet Kale" (salad product) packed in 10.9oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0526-2022·2022-02-02

    Fresh Express Asian Avocado Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Asian Avocado salad products in 9.7oz packages due to potential contamination with Listeria monocytogenes. The recall affects approximately 1,053 cases distributed across multiple U.S. states and Canada.

    Product
    "Asian Avocado" (salad product) packed in 9.7oz. 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 (Food)·F-0563-2022·2022-02-02

    Italian Salad Product Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Italian salad in 9oz. packages due to potential Listeria monocytogenes contamination. The affected product was distributed to retailers across the United States and Canada.

    Product
    "Italian" (salad product) packed in 9oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0561-2022·2022-02-02

    Green Leaf Shreds Salad Recalled for Potential Listeria Contamination

    Fresh Express Inc recalls Green Leaf Shreds salad packages due to potential Listeria monocytogenes contamination. The product was distributed to 110 domestic distributors across 20 U.S. states and 3 foreign distributors.

    Product
    "Green Leaf Shreds" (salad product) packed in 4.5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0402-2022·2022-02-02

    Epinephrine/Lidocaine Ophthalmic Injection Syringe Recall for Sterility Assurance

    Edge Pharma is recalling Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection due to lack of assurance of sterility. The recall affects 2,568 single-use syringes distributed nationwide.

    Product
    Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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 (Food)·F-0531-2022·2022-02-02

    Fresh Express Bacon & Blue Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling "Bacon & Blue" salad products (10.8 oz and 10.9 oz packages) distributed across 20 U.S. states and Canada due to potential Listeria monocytogenes contamination.

    Product
    "Bacon & Blue" (salad product) packed in 10.8oz. and 10.9oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0418-2022·2022-02-02

    Phenylephrine Injection Recall Due to Sterility Assurance Concerns

    Edge Pharma is recalling phenylephrine injection (20 mg/250 mL) because the manufacturer cannot assure the product maintains sterility. The recall affects 3,930 bags distributed nationwide.

    Product
    PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use bag for IV injection (Preservative Free), Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT NDC 05446-1667-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0586-2022·2022-02-02

    Organic Super Greens Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling "Organic Super Greens" salad in 5oz and 16oz packages due to potential Listeria monocytogenes contamination. The recall affects 7,603 cases distributed to domestic and Canadian distributors.

    Product
    "Organic Super Greens" (salad product) packed in 5oz. and 16oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0567-2022·2022-02-02

    Fresh Express Leafy Romaine Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Leafy Romaine salad in 9oz. and 10oz. packages due to potential Listeria monocytogenes contamination. The product was distributed to multiple states and Canada.

    Product
    "Leafy Romaine" (salad product) packed in 9oz. and 10oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0603-2022·2022-02-02

    Fresh Express Sweet Butter Salad Recalled for Listeria Contamination

    Fresh Express Inc is recalling approximately 98,358 cases of "Sweet Butter" salad in 6oz. packages due to potential Listeria monocytogenes contamination. The product was distributed to retailers in 20 U.S. states and Canada.

    Product
    "Sweet Butter" (salad product) packed in 6oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0558-2022·2022-02-02

    Farmer's Garden Salad Recalled for Potential Listeria Contamination

    Fresh Express Inc is recalling Farmer's Garden 9oz. salad packages due to potential contamination with Listeria monocytogenes. The product was distributed to multiple domestic and Canadian distributors.

    Product
    "Farmer's Garden" (salad product) packed in 9oz. 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-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-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 (Drugs)·D-0413-2022·2022-02-02

    Phenol Injection Solution Recall Due to Lack of Sterility Assurance

    Edge Pharma, LLC is recalling Phenol Sterile Solution for Injection (6%, 5 mL vials) nationwide due to lack of assurance of sterility. The recall affects 309 vials distributed under specific lot codes.

    Product
    Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1476-05, packaged in vials.
    Category
    Drug
    Distribution
    Distributed nationwide