The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. 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.

12801–12825 of 29186

  • SevereNHTSA·19V123000·2019-02-25

    Jayco Recalls 2019 Embark Motorhomes Due to Brake Component Defect

    Jayco is recalling 2019 Embark motorhomes because missing or improperly installed cotter pins may cause brake actuator rods to detach, increasing stopping distance and crash risk.

    Product
    JAYCO — JAYCO EMBARK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19E015000·2019-02-25

    Meritor Recalls EX225 Disc Brake Calipers Due to Cracked Drive Pins

    Meritor is recalling specific EX225 disc brake calipers because cracked drive pins may fracture, causing the vehicle to pull to one side while braking and increasing crash risk.

    Product
    SERVICE BRAKES, AIR:DISC:CALIPER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V124000·2019-02-25

    Entegra Reatta Motorhomes Recalled for Front Brake Defect

    Entegra is recalling 2019 Reatta motorhomes because missing or improper cotter pins on front brakes may reduce stopping power and increase crash risk.

    Product
    ENTEGRA — ENTEGRA REATTA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V120000·2019-02-22

    Kia Recalls 2012-2016 Soul Vehicles Due to Engine Fire Risk

    Kia is recalling 2012-2016 Soul vehicles with 1.6L GDI engines because high exhaust temperatures may damage the catalytic converter, potentially causing engine failure or fire.

    Product
    KIA — KIA SOUL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·019-2019·2019-02-22

    Fulton Seafood Recalls Wild Caught Catfish Lacking Federal Inspection

    Fulton Seafood Inc. is recalling approximately 100,924 pounds of wild caught catfish produced without federal inspection. The products were distributed to retail locations in Texas.

    Product
    Fulton Seafood Inc. Recalls Siluriformes Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereUSDA FSIS·018-2019·2019-02-22

    TV Food LLC Recalls Uninspected Frozen Catfish Products Nationwide

    TV Food LLC is recalling approximately 27,956 pounds of frozen catfish products because they were produced without federal inspection. Consumers are urged to discard or return the items.

    Product
    TV Food LLC. Recalls Siluriformes Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·19V107000·2019-02-21

    Mack Trucks Recalls Pinnacle and Anthem Models for Brake Tank Defect

    Mack Trucks is recalling certain Pinnacle and Anthem vehicles because undersized air brake supply tanks may reduce braking performance and increase crash risk.

    Product
    MACK — MACK PINNACLE (CHU), PINNACLE (CXU), ANTHEM (AN)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V103000·2019-02-21

    Ford Transit Hybrid Driveshaft Recall Due to Detachment Risk

    XL Hybrids is recalling 2015-2018 Ford Transit vehicles modified with their electric hybrid system because the front driveshaft may detach, increasing crash risk.

    Product
    FORD — FORD TRANSIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V098000·2019-02-21

    Isuzu Reach Recall: Front Driveshaft Joint May Fail

    XL Hybrids is recalling 2013-2018 Isuzu Reach vehicles with electric hybrid systems because the front driveshaft joint may fail, risking loss of drive power and crashes.

    Product
    ISUZU — ISUZU REACH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0466-2019·2019-02-20

    Promise Pharmacy Recalls ICB-Complex Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 846 vials of ICB-Complex injection nationwide due to a lack of sterility assurance.

    Product
    ICB-Complex, injection,Inositol/Choline/B1/B2/B3/B5/B6/B12/Leucine/Carnitine/Chromium/Lidocaine: 25mg/25mg/5mg/2.5mg/25mg/5mg/5mg/0.1mg/1.5mg/25mg/25mg/10mg/ML, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0463-2019·2019-02-20

    Promise Pharmacy Recalls Sermorelin Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 266 vials of Sermorelin 15mg injections because they lack sterility assurance. The products were distributed nationwide.

    Product
    Sermorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0476-2019·2019-02-20

    Promise Pharmacy Recalls Leucine/Isoleucine/Valine Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling Leucine/Isoleucine/Valine injection vials due to a lack of sterility assurance. The affected products were distributed nationwide.

    Product
    Leucine/Isoleucine/Valine injection, 10mg/10mg/5mg/mL/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0494-2019·2019-02-20

    Tris Pharma Recalls Superpotent Infant Ibuprofen Suspension

    Tris Pharma is recalling specific lots of infant ibuprofen suspension because the medication may contain higher concentrations than labeled.

    Product
    infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-24.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0929-2019·2019-02-20

    Oskri Organic Sunflower Butter Recalled for Listeria Risk

    Oskri Corp. is recalling specific lots of Organic Sunflower Butter due to potential Listeria monocytogenes contamination. The recall was expanded to include all Oskri manufactured butters.

    Product
    Organic Sunflower Butter, packaged under the following Brands. - Wholesome Pantry Organic Unsalted Sunflower Butter 16 oz. plastic jars UPC 04119005827. - Oskri branded 16 oz plastic jar UPC 66016-31630. Oskri, 528 E. Tyranena Park Rd, Lake Mills, WI 53551.
    Category
    Food
    Distribution
    21 states
  • SevereFDA (Drugs)·D-0469-2019·2019-02-20

    Promise Pharmacy Recalls Niacinamide Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling Niacinamide injection, 100mg/mL, 5mL vials due to a lack of sterility assurance. The product was distributed nationwide in the USA.

    Product
    Niacinamide injection, 100mg/mL, 5mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0461-2019·2019-02-20

    Promise Pharmacy Recalls HCG Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 2,595 vials of HCG injections nationwide due to a lack of sterility assurance.

    Product
    HCG, Human chorionic gonadotropin 5,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0452-2019·2019-02-20

    Promise Pharmacy Recalls Ipamorelin Injection Due to Sterility Concerns

    Promise Pharmacy is recalling 927 vials of Ipamorelin+Modified GRF 1-29 injection because of a lack of sterility assurance.

    Product
    Ipamorelin+Modified GRF 1-29, 9 mg/5mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0821-2019·2019-02-20

    Elekta MOSAIQ Oncology System Recalled for Potential Radiation Dose Errors

    Elekta is recalling MOSAIQ Oncology Information Systems because missing wedge IDs may cause patients to receive higher radiation doses than planned.

    Product
    MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0432-2019·2019-02-20

    Promise Pharmacy Recalls Prednisolone and Moxifloxacin Eye Drops for Sterility Concerns

    Promise Pharmacy is recalling 43 bottles of compounded Prednisolone and Moxifloxacin ophthalmic solution due to a lack of sterility assurance.

    Product
    Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0860-2019·2019-02-20

    Salmon River Foods Recalls Forest Wild Dark Chocolate Bars for Undeclared Milk

    Salmon River Foods is recalling Forest Wild Dark Chocolate bars due to undeclared milk. The product was distributed in Massachusetts and Wisconsin.

    Product
    The Forest Wild Collection Dark Chocolate bar, CB15052, net wt. 1.25 oz per bar. Product is packaged in a card board box of 12 individually wrapped chocolate bars. Dream Chocolate brand, UPC on each bar is 6 76181 15088 1. Label has the wolf image. The label is read in…
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0437-2019·2019-02-20

    Promise Pharmacy Recalls Prednisolone and Bromfenac Ophthalmic Solution for Sterility Concerns

    Promise Pharmacy is recalling 167 bottles of compounded Prednisolone and Bromfenac Ophthalmic Solution due to a lack of sterility assurance.

    Product
    Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0439-2019·2019-02-20

    Promise Pharmacy Recalls Multi Trace Injection Due to Sterility Concerns

    Promise Pharmacy is recalling Multi Trace injection vials because they may lack sterility assurance. The recall covers 30 mL vials distributed nationwide.

    Product
    Multi Trace, Zinc/Copper/Manganese/Selenium 5mg/1mg/0.5mg/60mcg/ml, injection 30 mL, Rx Only, Compounded Prescription, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0830-2019·2019-02-20

    AtriCure Recalls COBRA FUSION 150 Ablation System Due to Thromboembolism Risk

    AtriCure is recalling 6,176 units of the COBRA FUSION 150 Ablation System because patients may face an elevated risk of thromboembolism during specific off-pump procedures.

    Product
    COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Drugs)·D-0471-2019·2019-02-20

    Promise Pharmacy Recalls Zinc Sulfate Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling specific lots of Zinc Sulfate injection due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Zinc Sulfate, 5mg/mL injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0448-2019·2019-02-20

    Promise Pharmacy Recalls Sermorelin Theanine/GHRP2 Injection Due to Sterility Concerns

    Promise Pharmacy is recalling Sermorelin Theanine/GHRP2 injections due to a lack of sterility assurance. The affected lot was distributed nationwide.

    Product
    Sermorelin Theanine/GHRP2, 15 mg/75 mg/5.4 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide