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.

3976–4000 of 4878

  • SevereFDA (Food)·F-0528-2022·2022-02-02

    Baby Greens Salad Recalled Due to Potential Listeria Monocytogenes Contamination

    Fresh Express Inc is recalling 611 units of Baby Greens salad in 6oz packages due to potential Listeria monocytogenes contamination. The product was distributed to 110 domestic distributors across 20 states and Canada.

    Product
    "Baby Greens" (salad product) packed in 6oz. packages
    Category
    Food
    Distribution
    20 states
  • 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-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-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-0527-2022·2022-02-02

    Fresh Express Avocado Ranch Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Avocado Ranch salad products in 9.7oz and 12.8oz packages due to potential Listeria monocytogenes contamination. The products were distributed to wholesalers across 20 U.S. states and Canada.

    Product
    "Avocado Ranch" (salad product) packed in 9.7oz. and 12.8oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0570-2022·2022-02-02

    Old Fashion Coleslaw Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Old Fashion Coleslaw (14oz packages) due to potential Listeria monocytogenes contamination across 20 U.S. states and Canada.

    Product
    "Old Fashion Coleslaw" (salad product) packed in 14oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0421-2022·2022-02-02

    Sterile Ophthalmic Solution Lacks Assurance of Sterility

    Edge Pharma is recalling a sterile ophthalmic solution due to lack of assurance of sterility. The recall affects 2,562 syringes distributed nationwide.

    Product
    Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe, Single Use Syringe, For Topical Ophthalmic Use, NDC 05446-0993-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0407-2022·2022-02-02

    Mitomycin-C Injectable Syringes Recalled for Sterility Assurance Failure

    Edge Pharma is recalling Mitomycin-C 40 mg/40 mL single-dose syringes (NDC 05446-1416-01) nationwide due to lack of assurance of sterility. Approximately 860 syringes are affected.

    Product
    Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1416-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0395-2022·2022-02-02

    Lidocaine HCl Sterile Buffered Solution Recalled for Lack of Sterility Assurance

    Edge Pharma is recalling Lidocaine HCl Sterile Buffered Solution for Injection (1%, 10 mL syringes) due to lack of assurance of sterility. The recall affects approximately 4,465 syringes distributed nationwide.

    Product
    Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe for Infiltration and Nerve Block, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0850-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0392-2022·2022-02-02

    Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Contamination

    Viona Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release 750 mg tablets due to detection of N-Nitrosodimethylamine (NDMA) at levels exceeding the acceptable daily intake limit. The contamination resulted from manufacturing deviations.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-0538-2022·2022-02-02

    Fresh Express Chicken Caesar Bowl Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Chicken Caesar Bowl salads in 5.7oz and 5.75oz packages due to potential Listeria monocytogenes contamination. The product was distributed to domestic and Canadian distributors.

    Product
    "Chicken Caesar Bowl" (salad product) packed in 5.7oz. and 5.75oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0580-2022·2022-02-02

    Fresh Express Organic Half & Half Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Organic Half & Half salad in 5oz. and 16oz. packages due to potential Listeria monocytogenes contamination. The product was distributed across the United States and Canada.

    Product
    "Organic Half & Half" (salad product) packed in 5oz. and 16oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0606-2022·2022-02-02

    Sweet Lettuce salad products recalled for potential Listeria contamination

    Fresh Express Inc is recalling Sweet Lettuce salad products in 5oz packages due to potential contamination with Listeria monocytogenes. The affected products were distributed to wholesalers across the United States and Canada.

    Product
    "Sweet Lettuce" (salad product) packed in 5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0596-2022·2022-02-02

    Slivered Onions Recalled for Potential Listeria Contamination

    Fresh Express Inc is recalling Slivered Onions (1 lb packages) due to potential contamination with Listeria monocytogenes. The product was distributed to domestic and Canadian distributors.

    Product
    "Slivered Onions" (salad product) packed in 1lb. 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-0412-2022·2022-02-02

    MVASI Sterile Ophthalmic Solution Lacks Assured Sterility

    Edge Pharma is recalling MVASI (bevacizumab-awwb) intraocular injection syringes nationwide due to lack of assurance of sterility. The recall affects 199 syringes with code 11-2021-01@2 dated 12/15/2021.

    Product
    MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.13mL (25 mg/mL) 0.13 mL per syringe, Dose: 1.25mg/0.05mL, Single Use Syringe For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1661-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0419-2022·2022-02-02

    Edge Pharma Phenylephrine/Lidocaine Ophthalmic Solution Sterility Recall

    Edge Pharma is recalling Phenylephrine HCl/Lidocaine sterile ophthalmic solution for injection due to lack of assurance of sterility. The recalled product consists of 2,750 single-use syringes distributed nationwide.

    Product
    Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free, 1.5%/1%, 0.8mL per syringe, Single Use Syringe For Intraocular Injection, Edge Pharma LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1118-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-0581-2022·2022-02-02

    Organic Herb Mix Salad Recalled for Potential Listeria Contamination

    Fresh Express Inc's Organic Herb Mix salad product has been recalled due to potential Listeria monocytogenes contamination. The recall affects 6,137 cases distributed across multiple states and Canada.

    Product
    "Organic Herb Mix" (salad product) packed in 5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0583-2022·2022-02-02

    Organic Mixed Greens Salad Recalled for Listeria monocytogenes Risk

    Fresh Express Inc is recalling Organic Mixed Greens in 5oz. packages due to potential Listeria monocytogenes contamination. The product was distributed to retailers and distributors across 20 U.S. states and Canada.

    Product
    "Organic Mixed Greens" (salad product) packed in 5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0551-2022·2022-02-02

    Chopped Sunflower Salad Recall: Listeria Contamination Risk

    Fresh Express Inc is recalling Chopped Sunflower salad products in 11.1oz. and 11.3oz. packages due to potential Listeria monocytogenes contamination. The products were distributed to multiple states and Canada.

    Product
    "Chopped Sunflower" (salad product) packed in 11.1oz. and 11.3oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0539-2022·2022-02-02

    Fresh Express "Chopped Asian" Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling "Chopped Asian" salad products in multiple package sizes due to potential Listeria monocytogenes contamination. The products were distributed to domestic and Canadian retailers.

    Product
    "Chopped Asian" (salad product) packed in 12oz., 12.3oz., and 13.6oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0396-2022·2022-02-02

    Edge Pharma Lidocaine HCl/Epinephrine Injection Lacks Sterility Assurance

    Edge Pharma is recalling approximately 8,140 syringes of Lidocaine HCl/Epinephrine sterile buffered injection solution due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, (802) 992-1178, NDC 05446-1268-01
    Category
    Drug
    Distribution
    Distributed nationwide