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.

4076–4100 of 4878

  • SevereFDA (Food)·F-0566-2022·2022-02-02

    Fresh Express Kale Caesar Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Kale Caesar salad in 8.5oz packages due to potential Listeria monocytogenes contamination. Affected products were distributed across 23 US states and Canada.

    Product
    "Kale Caesar" (salad product) packed in 8.5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0424-2022·2022-02-02

    Vancomycin HCl Ophthalmic Solution Recalled for Sterility Assurance

    Edge Pharma LLC is recalling Vancomycin HCl sterile ophthalmic solution for injection due to lack of assurance of sterility. The affected product was distributed nationwide.

    Product
    Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/mL) (vancomycin equivalent), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0736-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0585-2022·2022-02-02

    Organic Spring Mix and Spinach Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Organic Spring Mix and Spinach salad products in multiple package sizes due to potential Listeria monocytogenes contamination. The products were distributed to retailers in 20 U.S. states and Canada.

    Product
    "Organic Spring Mix and Spinach" (salad product) packed in 5oz., 11oz., and 16oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0529-2022·2022-02-02

    Baby Kale Salad Recalled Due to Listeria Contamination Risk

    Fresh Express Inc is recalling Baby Kale salad in 5oz packages due to potential Listeria monocytogenes contamination. The product was distributed to domestic and Canadian distributors.

    Product
    "Baby Kale" (salad product) packed in 5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0541-2022·2022-02-02

    Fresh Express Chopped Bacon Ranch Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling 1,540 cases of Chopped Bacon Ranch salad (12.8oz. packages, codes Z324-Z350) because the product has the potential to be contaminated with Listeria monocytogenes. The salad was distributed to domestic and Canadian distributors.

    Product
    "Chopped Bacon Ranch" (salad product) packed in 12.8oz. 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-0604-2022·2022-02-02

    Sweet Dijon Onion Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Sweet Dijon Onion salad products in 7.6oz. packages due to potential Listeria monocytogenes contamination. The product was distributed to retailers across 20 US states and Canada.

    Product
    "Sweet Dijon Onion" (salad product) packed in 7.6oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0608-2022·2022-02-02

    Fresh Express Twisted Chopped Asian Caesar Salad Recalled for Listeria

    Fresh Express Inc is recalling Twisted Chopped Asian Caesar salad in 9.6oz packages due to potential Listeria monocytogenes contamination. The product was distributed to domestic and Canadian distributors.

    Product
    "Twisted Chopped Asian Caesar" (salad product) packed in 9.6oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0547-2022·2022-02-02

    Fresh Express Chopped Kit Poppyseed Recalled for Listeria Risk

    Fresh Express Inc. is recalling approximately 11,668 cases of "Chopped Kit Poppyseed" salad products due to potential contamination with Listeria monocytogenes. The products were distributed to retailers and distributors in 20 U.S. states and Canada.

    Product
    "Chopped Kit Poppyseed" (salad product) packed in 11.7oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0535-2022·2022-02-02

    Caesar Lite Salad Recalled for Potential Listeria Contamination

    Fresh Express Inc is recalling 12,835 cases of Caesar Lite salad product (9.8 oz packages) due to potential contamination with Listeria monocytogenes. The affected product was distributed to domestic and Canadian distributors.

    Product
    "Caesar Lite" (salad product) packed in 9.8oz. 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-0572-2022·2022-02-02

    Fresh Express Organic Baby Arugula & Spinach Recall for Listeria Contamination

    Fresh Express Inc is recalling approximately 12,107 cases of Organic Baby Arugula & Baby Spinach salad mix due to potential contamination with Listeria monocytogenes. The affected product was distributed across multiple states and Canada.

    Product
    "Organic Baby Arugula & Baby Spinach" (salad product) packed in 5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0525-2022·2022-02-02

    Fresh Express Angel Hair Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling 3,943 cases of "Angel Hair" salad in 10oz. packages due to potential Listeria monocytogenes contamination. The products were distributed to domestic and Canadian retailers.

    Product
    "Angel Hair" (salad product) packed in 10oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0532-2022·2022-02-02

    Fresh Express Bacon Thousand Island Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Bacon Thousand Island salad in 9.4 oz packages due to potential Listeria monocytogenes contamination. The recall affects 9,116 cases distributed across multiple U.S. states and Canada.

    Product
    "Bacon Thousand Island" (salad product) packed in 9.4oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0565-2022·2022-02-02

    Fresh Express Juicing Greens salad recalled for potential Listeria contamination

    Fresh Express is recalling Juicing Greens salad products (11oz packages, codes Z324-Z350) due to potential Listeria monocytogenes contamination. The products were distributed to retailers in 20 U.S. states and Canada.

    Product
    "Juicing Greens" (salad product) packed in 11oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0530-2022·2022-02-02

    Fresh Express Baby Spinach Recalled for Listeria Contamination Risk

    Fresh Express Inc has recalled approximately 97,461 cases of Baby Spinach sold in 5oz. to 20oz. packages due to potential Listeria monocytogenes contamination. The affected product was distributed to wholesalers across 20 U.S. states and Canada.

    Product
    "Baby Spinach" (salad product) packed in 5oz., 6oz., 10oz., 11oz., 16oz., and 20oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0377-2022·2022-01-26

    SENNA Syrup unit-dose cups recalled for microbial contamination

    Lohxa, LLC is recalling SENNA Syrup (sennosides) 8.8 mg/5 mL unit-dose cups due to microbial contamination of the non-sterile product. The recall affects Lot #AM1115S with expiration date 01/2023, distributed nationwide.

    Product
    SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: AvKARE, TN 38478, NDC 50262-731-24.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0505-2022·2022-01-26

    Haifa Smoked Turbot Fish Recalled for Listeria Contamination

    D & M Smoked Fish, Inc. is recalling Haifa Smoked Turbot Cold Smoked (8 oz) because it may be contaminated with Listeria monocytogenes. The product was distributed in New York and New Jersey.

    Product
    "Haifa Smoked Fish and Caviar*** Turbot Cold Smoked***Net Wt 8 0z."
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0462-2022·2022-01-26

    Semglee Insulin Glargine Prefilled Pens Missing Label

    Mylan Pharmaceuticals is recalling approximately 73,175 Semglee (insulin glargine) prefilled pens nationwide because some units have a missing label. Patients should check their pens and contact their pharmacist or doctor if affected.

    Product
    Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 mL Prefilled Pens per carton (NDC 49502-0196-75), Rx only, Manufactured in Malaysia for: Mylan Specialty L.P., Morgantown, WV, 26505.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0451-2022·2022-01-26

    Medtronic HawkOne Directional Atherectomy Device Recalled for Tip Damage

    Medtronic is recalling 28,094 units of its HawkOne directional atherectomy system due to reports of catheter tip damage and detachment that can cause blood clots in blood vessels.

    Product
    Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral vasculature.
    Category
    Medical Device
    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 (Food)·F-0420-2022·2022-01-19

    BlakeFit Everyday Gold Raspberry Lemonade Recalled for Undeclared Milk

    NutraCap Labs LLC is recalling BlakeFit Everyday Gold Raspberry Lemonade Sample due to undeclared milk. The product was distributed across 25 states and poses a risk to consumers with milk allergies.

    Product
    BlakeFit Everyday Gold Raspberry Lemonade Sample NO BARCODE
    Category
    Food
    Distribution
    26 states
  • SevereFDA (Food)·F-0467-2022·2022-01-19

    Myoblox Contra Capsules recalled for undeclared milk allergen

    NutraCap Labs LLC is recalling Myoblox Contra Capsules because the product contains undeclared milk. Consumers with milk allergies or sensitivity should not use this product.

    Product
    Myoblox Contra Capsules 56ct Bottle UPC CODE 8 50001 91230 3
    Category
    Food
    Distribution
    26 states
  • SevereFDA (Food)·F-0400-2022·2022-01-19

    Steel VEG-PRO Cookies & Creme Protein Powder Recalled for Undeclared Wheat

    NutraCap Labs LLC is recalling Steel VEG-PRO Cookies & Creme 100% Pure Vegan Protein because it contains undeclared wheat, a major food allergen. Affected consumers should stop using the product.

    Product
    STEEL VEG-PRO COOKIES & CREME 100% PURE VEGAN PROTEIN NET WT. 1.43LBS (650G) Other Ingredients: Brown Rice Protein, Pea Protein Isolate, Natural Flavors, Oreo Cookie Bits Xanthian Gum, Salt, Steviol Glycoside (95%), Sucralose. MANUFACTURED EXCLUSIVELY FOR AND DISTRIBUTED BY: STEE
    Category
    Food
    Distribution
    26 states
  • SevereFDA (Food)·F-0430-2022·2022-01-19

    Dube Ortho & PT capsules recalled for undeclared shellfish

    NutraCap Labs LLC is recalling Dube Ortho & PT 144 capsules due to undeclared shellfish in the product. The recall affects 80,169 bottles distributed across 25 states.

    Product
    Dube Ortho & PT 144 Bottles Capsules 60ct No UPC CODE
    Category
    Food
    Distribution
    26 states