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.

9876–9900 of 29157

  • SevereNHTSA·20V165000·2020-03-19

    BMW Recalls 2020 R 1250 RT and GS Motorcycles for Driveline Defect

    BMW is recalling 2020 R 1250 RT and GS motorcycles because a damaged pivot pin may loosen the final drive connection, increasing crash risk.

    Product
    BMW — BMW R 1250 RT, R 1250 GS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0817-2020·2020-03-18

    Tova Industries Recalls American Bounty Chili Mix Due to Metal Shavings

    Tova Industries is recalling American Bounty Chili Mix w/Beans because of possible metal shavings in an ingredient. The recall covers 225 cases distributed to 11 states and the UAE.

    Product
    American Bounty brand Chili Mix w/Beans, Item #46628, in 20.8 oz. metallic pouches, 6 pouches per case.
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-0832-2020·2020-03-18

    Chocolate Dairy Powder Recalled Due to Potential Metal Fragment Contamination

    International Food Products Corporation is recalling 21 bags of chocolate dairy powder because an ingredient may have been contaminated with metal fragments.

    Product
    Profile Food Ingredients, 10# Choc Dairy Pwd PFI-1010, packaged in 50 lb bags.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0827-2020·2020-03-18

    Domino Foods Recalls Great Value Sugar Due to Metal Contamination

    Domino Foods Inc. is recalling Great Value Pure Granulated Sugar because it may contain metal pieces. The product was shipped to one consignee in Pennsylvania.

    Product
    GREAT VALUE¿ Pure Granulated Sugar, 10 lbs. Sold as individual bags on a unitized 1/2 pallet 78 bags to a 1/2 pallet.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1427-2020·2020-03-18

    HeartWare HVAD System Battery Charger Recalled for Adapter Insertion Risk

    Heartware, Inc. is recalling 5,489 HeartWare HVAD System Battery Chargers because users may mistakenly insert the AC adapter into the HVAD Controller power port.

    Product
    HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1004-2020·2020-03-18

    Precision Dose Recalls Ranitidine Oral Solution Due to NDMA Impurity

    Precision Dose Inc. is recalling Ranitidine Oral Solution because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only, Precision Dose, Inc., South Beloit, IL 61080
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V154000·2020-03-18

    Bentley Recalls Bentayga Vehicles Due to Third-Row Seat Belt Defect

    Bentley is recalling 2018-2020 Bentayga vehicles with third-row seats because the upper seat belt attachment may detach in a crash, increasing injury risk.

    Product
    BENTLEY — BENTLEY BENTAYGA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0831-2020·2020-03-18

    Maryland Packaging Recalls Pure Cane Sugar Due to Metal Wire

    Maryland Packaging, LTD. is recalling 4,056 bags of Pure Cane Granulated Sugar in Pennsylvania and Maryland because the product may contain a metal wire.

    Product
    Pure Cane Granulated Sugar, Single 10 lb. package, 156 paper bags on 2 1/2 CHEP pallets
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1010-2020·2020-03-18

    Redline Pharmacy Recalls Vancomycin Injectable Due to Processing Control Deficiencies

    Redline Pharmacy Solutions is recalling 3 doses of Vancomycin 900MG Injectable due to a lack of processing controls. The product was sold to patients in Nebraska.

    Product
    Vancomycin 900MG in 100ML 0.9% NACL Injectable, Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0812-2020·2020-03-18

    Tova Industries Recalls Shaver Foods Gravy Beef Due to Metal Shavings

    Tova Industries is recalling Shaver Foods brand Gravy Beef because of possible metal shavings in the ingredient. The product was distributed to 11 states and the United Arab Emirates.

    Product
    Shaver Foods brand Gravy Beef, Item #35089, in 2 lb. metallic pouches, 12 pouches per case.
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Drugs)·D-1011-2020·2020-03-18

    Redline Pharmacy Recalls Morphine Sulfate Due to Processing Controls

    Redline Pharmacy Solutions is recalling Morphine Sulfate (MITIGO) 5 mg/mL intrathecal syringes due to a lack of processing controls.

    Product
    Morphine Sulfate (MITIGO), 5 mg/mL intrathecal, 40 mL per syringe. Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1003-2020·2020-03-18

    American Health Packaging Recalls Ranitidine Tablets Due to NDMA Levels

    American Health Packaging is recalling 53,619 cartons of Ranitidine Tablets, 150 mg, due to potential N-Nitrosodimethylamine (NDMA) amounts above FDA-established levels.

    Product
    Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1476-2020·2020-03-18

    Qiagen Rotor-Gene Q Software Recall for Incorrect Concentration Reporting

    Qiagen is recalling Rotor-Gene Q instruments with software version 2.3.4 because a bug causes concentration results to be reported as logarithmic values, potentially leading to false negative test results.

    Product
    QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1009-2020·2020-03-18

    Redline Pharmacy Recalls Ertapenem Injectable Due to Processing Control Issues

    Redline Pharmacy Solutions is recalling 8 doses of Ertapenem Injectable due to a lack of processing controls. The product was sold to patients in Nebraska.

    Product
    Ertapenem in 100ML 0.9% NACL 1GM Injectable, Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1007-2020·2020-03-18

    Redline Pharmacy Recalls Morphine Sulfate Due to Processing Control Deficiencies

    Redline Pharmacy Solutions is recalling Morphine Sulfate 20 mg/mL intrathecal syringes due to a lack of processing controls. The product was sold to patients in Nebraska.

    Product
    Morphine Sulfate, 20 mg/mL intrathecal, 20 mL per syringe. Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
    Category
    Drug
    Distribution
    1 state
  • SevereCPSC·20090·2020-03-17

    Honda Recalls Portable Generators Due to Fire and Burn Hazards

    American Honda is recalling about 340,000 portable generators because the inverter assembly can short-circuit in salt water, causing smoke or fire.

    Product
    Honda EB2200i, EU2200i, EU2200i Companion and EU2200i Camo Portable Generators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V149000·2020-03-16

    Audi Recalls Q7 and Q8 Models Due to Steering Shaft Bolt Issue

    Volkswagen Group of America is recalling 2017-2019 Audi Q7 and 2019 Q8 vehicles because a steering shaft bolt may loosen, potentially causing a loss of steering control.

    Product
    AUDI — AUDI Q7, Q8
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20T006000·2020-03-13

    Tornel Deportiva Tires Recalled for Tread Separation Risk

    Tornel is recalling specific Deportiva tires where adhesive failure may cause tread separation, increasing the risk of vehicle control loss and crashes.

    Product
    TIRES:TREAD/BELT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V142000·2020-03-12

    GM Recalls 2020 Silverado and Sierra Trucks for Hood Latch Defect

    General Motors is recalling 2020 Chevrolet Silverado and GMC Sierra trucks because improperly heat-treated hood-latch wires may fracture, allowing the hood to open while driving.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO 2500, SILVERADO 3500, SIERRA 2500, SIERRA 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0991-2020·2020-03-11

    Axia Pharmaceutical Recalls Triamcinolone Diacetate Injectable Suspension Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Triamcinolone Diacetate Injectable Suspension because the product lacks assurance of sterility.

    Product
    Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE [10ML] CMC 80 MG/ML INJ SUSP, For IM, IA, IT Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0634-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0981-2020·2020-03-11

    Axia Pharmaceutical Recalls Selenium Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Selenium Injection because the product lacks assurance of sterility.

    Product
    Selenium Injection, SELENIUM 200MCG/ML INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0227-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0972-2020·2020-03-11

    Axia Pharmaceutical Recalls Methylprednisolone Acetate Injectable Suspension Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Methylprednisolone Acetate Injectable Suspension because the company cannot guarantee the product is sterile.

    Product
    Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE [10ML] CMC 50 MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0636-1
    Category
    Drug
    Distribution
    Distributed nationwide