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.

8201–8225 of 29123

  • SevereFDA (Food)·F-0567-2021·2021-06-02

    Indianapolis Fruit Company Recalls Organic Coleslaw Due to Plastic Foreign Material

    Indianapolis Fruit Company is recalling Garden Cut Coleslaw W/ Carrot Organic due to the presence of plastic foreign material. The product was distributed to retailers in six states.

    Product
    Garden Cut Coleslaw W/ Carrot Organic, 1lb plastic clamshell, UPC 053495081016, 4 1lb retail units per wholesale case. Item number: CACO41L / 17671
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0632-2021·2021-06-02

    Sara Lee and Chef Pierre Pecan Pies Recalled for Undeclared Peanut

    Sara Lee Frozen Foods is recalling specific pecan pie products due to potentially undeclared peanut. Consumers should check labels and stop using the affected items.

    Product
    Sara Lee Pecan Pie 4oz. retail packaged UPC 032100051118, 24 and 48 count wholesale case; Chef Pierre Southern Pecan Pie, 10 slices, 36oz. retail packaged UPC 032100092739, 6 pies per wholesale case; Chef Pierre Pecan Pie, 10 slices, 36oz. retail packaged UPC 032100093750, 6 pies
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V418000·2021-06-02

    Stonebrooke RAM 5500 Recalled for Rear Brake Fluid Leak Risk

    Stonebrooke is recalling one 2019 RAM 5500 because the rear brake line can wear and leak, increasing crash risk.

    Product
    STONEBROOKE EQUIPMENT — STONEBROOKE EQUIPMENT RAM 5500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1626-2021·2021-06-02

    Philips Respironics BiPAP A40 Ventilators Recalled for Motor Assembly Defects

    Philips Respironics is recalling 10 BiPAP A40 ventilators due to non-conforming plastic in motor assemblies that may cause toxic off-gassing or sudden device failure.

    Product
    BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1627-2021·2021-06-02

    Philips BiPAP A40 System Silver Recalled for Motor Assembly Defects

    Philips Respironics is recalling specific BiPAP A40 System Silver units due to non-conforming plastic in motor assemblies that may cause off-gassing or sudden device failure.

    Product
    BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0399-2021·2021-06-02

    Acella Recalls Subpotent NP Thyroid 15 Tablets Nationwide

    Acella Pharmaceuticals is recalling NP Thyroid 15 tablets because they contain less active ingredient than labeled. The recall covers bottles distributed nationwide.

    Product
    NP THYROID 15 — NP THYROID 15 (LEVOTHYROXINE, LIOTHYRONINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0459-2021·2021-06-02

    Cardinal Health Recalls Synjardy Tablets Due to Temperature Excursions

    Cardinal Health is recalling 751 bottles of Synjardy XR tablets distributed in Florida, Georgia, and South Carolina due to intermittent temperature exposure during storage.

    Product
    SYNJARDY — SYNJARDY (EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    3 states
  • SevereNHTSA·21V407000·2021-05-29

    Ford Recalls 2021 F-150 Trucks Due to Steering Gear Defect

    Ford is recalling 2021 F-150 vehicles because internal steering gear damage could cause loss of steering control. Owners should not drive until the repair is complete.

    Product
    FORD — FORD F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V403000·2021-05-28

    Mercedes-Benz Recalls 2020 GLB 250 Vehicles for Water Intrusion Defect

    Mercedes-Benz is recalling 2020 GLB 250 vehicles because water may enter the foot wells, potentially causing electrical damage, engine stalls, or a blank instrument cluster.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLB 250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V406000·2021-05-28

    2021 Mercedes-Benz Cabriolets: Rear Headrests May Be Incorrectly Mounted

    Mercedes-Benz USA is recalling approximately 218 2021 Cabriolet models due to rear headrests that may be incorrectly mounted to the seatbacks. The headrests could move or detach during a crash, increasing the risk of injury.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ C 300, E 450, AMG E53, AMG C43
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·022-2021·2021-05-28

    King's Command Foods Recalls Meatballs and Pork Patties for Undeclared Allergens

    King's Command Foods is recalling approximately 20,025 pounds of meatballs and pork patties because they contain undeclared egg, milk, or wheat.

    Product
    King's Command Foods, LLC — King's Command Foods, LLC. Recalls Meat and Poultry Meatballs and Pork Pattie Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    10 states
  • SevereNHTSA·21V405000·2021-05-28

    Mercedes-Benz Recalls 2020 GLB 250 Vehicles for Air Bag Defect

    Mercedes-Benz is recalling 2020 GLB 250 vehicles because the front passenger air bag may tear upon deployment, increasing injury risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLB 250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V402000·2021-05-27

    2021 INFINITI QX50 Steering Knuckle Structural Defect - Multiple Models Affected

    Nissan recalls 2021 INFINITI QX50 and other vehicles due to front steering knuckles and rear axle housings with insufficient strength from improper heat treatment, which could deform on impact and cause loss of steering control or wheel separation.

    Product
    INFINITI — INFINITI, NISSAN QX60, MURANO, Q50, GT-R
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V401000·2021-05-27

    BMW Recalls 3 Series Vehicles for Air Bag Inflator Defect

    BMW is recalling 1999-2001 3 Series vehicles because the driver-side air bag inflator may explode or underinflate, posing a risk of serious injury.

    Product
    BMW — BMW 323CI, 328CI, 323I, 328I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1640-2021·2021-05-26

    Biopsybell 8G Direct Working Cannula Bevel Tip Recall for Sterility Concerns

    Biopsybell is recalling 8G Direct Working Cannula Bevel Tips labeled as sterile that may not have been sterilized. The recall affects 30 units distributed in Mississippi and Kentucky.

    Product
    8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1637-2021·2021-05-26

    Biopsybell 10 Gauge Direct Unilateral Stylets Recalled for Sterility Concerns

    Biopsybell S.R.L. is recalling 625 units of 10 Gauge Direct Unilateral Stylets because they were labeled as sterile but may not have been sterilized.

    Product
    10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0377-2021·2021-05-26

    Teva Recalls Metoclopramide Injection Due to Sterility Concerns

    Teva Pharmaceuticals is recalling specific lots of Metoclopramide Injection because there is a lack of assurance of sterility. The product was distributed nationwide.

    Product
    METOCLOPRAMIDE — METOCLOPRAMIDE (METOCLOPRAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0497-2021·2021-05-26

    A Life African Market Recalls Unlabeled Shrayy Chalk for Lead and Arsenic

    A Life African Market Corp is recalling 344 lbs of unlabeled Shrayy white chalk found to contain elevated levels of lead and arsenic. The product was distributed in New York, Delaware, Massachusetts, and Pennsylvania.

    Product
    Shrayy (white chalk) packaged in .68lb bags of synthetic plastic; no label on packaging
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0382-2021·2021-05-26

    FDA Recalls PremierZen Black 5000 for Unapproved Tadalafil

    Hyobin LLC is recalling PremierZen Black 5000 capsules because FDA analysis detected the unapproved drug tadalafil. The product was marketed without an approved NDA or ANDA.

    Product
    PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0549-2021·2021-05-26

    Faribault Foods Recalls O Organics Organic Black Beans Due to Seal Defects

    Faribault Foods is recalling O Organics Organic Black Beans because of compromised hermetic seals on the cans. Consumers should check their pantry for the specific UPC and best-by date.

    Product
    O Organics Organic Black Beans, 15 oz. can, UPC 0-79893-40610-7 Distributed by Lucerne Foods, Inc. P.O. Box 99, Pleasanton, CA 94566-0009, 1-800-232-4271
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Drugs)·D-0375-2021·2021-05-26

    Teva Recalls Haloperidol Decanoate Injection Due to Sterility Concerns

    Teva Pharmaceuticals is recalling 3,150 vials of Haloperidol Decanoate Injection due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 00703-7121-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0390-2021·2021-05-26

    Lupin Recalls Subpotent Cefixime Oral Suspension Bottles Nationwide

    Lupin Pharmaceuticals is voluntarily recalling 3,138 bottles of Cefixime for Oral Suspension because the drug is subpotent. The affected product was distributed nationwide in the United States.

    Product
    CEFIXIME — CEFIXIME (CEFIXIME)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1631-2021·2021-05-26

    BPB medica CEMIX Cement Mixing System Recalled for Sterility Concerns

    Biopsybell S.R.L. is recalling 5 units of the BPB medica CEMIX cement mixing system because products labeled as sterile may not have been sterilized.

    Product
    BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system
    Category
    Medical Device
    Distribution
    Distributed nationwide