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.

10326–10350 of 29158

  • SevereFDA (Drugs)·D-0711-2020·2020-01-22

    Assurance Infusion Recalls BUP/FENT Injection Due to Sterility Concerns

    Assurance Infusion is recalling BUP 5.3MG/FENT 1050 MCG/ML Injection in 20 mL syringes due to a lack of sterility assurance.

    Product
    BUP 5.3MG/ FENT 1050 MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0695-2020·2020-01-22

    Assurance Infusion Recalls BUP 21MG/CLON 252MCG/MORP 20MG/ML Injection Syringes

    Assurance Infusion is recalling BUP 21MG/CLON 252MCG/MORP 20MG/ML Injection syringes due to a lack of sterility assurance. The recall covers products distributed nationwide.

    Product
    BUP 21MG/CLON 252MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0668-2020·2020-01-22

    Assurance Infusion Recalls Multi-Drug Injection Syringes Due to Sterility Concerns

    Assurance Infusion is recalling specific syringes of a multi-drug injection due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    BAC 200MCG/BUP22MG/CLON210MCG/HYDROM 15MG/SUF800MCG/ML ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0719-2020·2020-01-22

    Assurance Infusion Recalls BUP 9MG/ HYDROM 25MG/ SUF 110MCG/ML INJ Syringes

    Assurance Infusion is recalling BUP 9MG/ HYDROM 25MG/ SUF 110MCG/ML INJ syringes due to a lack of sterility assurance.

    Product
    BUP 9MG/ HYDROM 25MG/ SUF 110MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0693-2020·2020-01-22

    Assurance Infusion Recalls BUP 20MG/SUF 1000MCG/ML Injection Syringes

    Assurance Infusion is recalling BUP 20MG/SUF 1000MCG/ML Injection syringes due to a lack of sterility assurance. The recall covers nationwide distribution in the United States.

    Product
    BUP 20MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0757-2020·2020-01-22

    Assurance Infusion Recalls Morphine Syringes Due to Sterility Concerns

    Assurance Infusion is recalling specific lots of Morphine 30mg/mL injection syringes due to a lack of sterility assurance. The affected products were distributed nationwide.

    Product
    MORPHINE 30MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0689-2020·2020-01-22

    Assurance Infusion Recalls Multi-Drug Injection Syringes Due to Sterility Concerns

    Assurance Infusion is recalling specific syringes of a multi-drug injection due to a lack of sterility assurance. The affected products were distributed nationwide.

    Product
    BUP 2.5MG/ CLONI 5MCG/ FENT 200MCG/ SUF 50MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0660-2020·2020-01-22

    Sun Pharma Recalls Sumatriptan Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling 207,585 blisters of Sumatriptan Succinate 100 mg tablets due to failed impurity specifications.

    Product
    Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0676-2020·2020-01-22

    Assurance Infusion Recalls Baclofen Syringes Due to Sterility Assurance Concerns

    Assurance Infusion is recalling specific lots of Baclofen injection syringes due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    BACLOFEN 2000MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0517-2020·2020-01-22

    Fresh Unlimited Recalls Cobb Salad Kits Due to Listeria Risk

    Fresh Unlimited Inc is recalling 8lb Cobb Salad Kits because eggs used in production may be contaminated with Listeria monocytogenes.

    Product
    Cobb Salad Kit: 8lbs packaged in cardboard box
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0682-2020·2020-01-22

    Assurance Infusion Recalls BUP 10MG/HYDROM 15MG/SUF 200MCG/ML Injection Syringes

    Assurance Infusion is recalling specific lots of BUP 10MG/HYDROM 15MG/SUF 200MCG/ML Injection syringes due to a lack of sterility assurance.

    Product
    BUP 10MG/HYDROM 15MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0661-2020·2020-01-22

    AvKARE Recalls Dutasteride Capsules Due to Impurity Specification Failures

    AvKARE Inc. is recalling specific lots of Dutasteride Capsules, 0.5 mg, because they failed impurity and degradation specifications.

    Product
    Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-282-13.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V032000·2020-01-20

    Arcimoto Recalls 2019 FUV Motorcycles Due to Brake Line Wear Risk

    Arcimoto is recalling 2019 FUV motorcycles because the brake line may contact the steering main-link, potentially causing a loss of braking ability and increasing crash risk.

    Product
    ARCIMOTO — ARCIMOTO FUV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V026000·2020-01-17

    Honda, Acura, and Isuzu Recall Vehicles for Air Bag Inflator Defect

    Honda is recalling specific Acura, Honda, and Isuzu vehicles because driver air bag inflators may rupture or underinflate, posing a risk of injury.

    Product
    ISUZU — ISUZU, HONDA, ACURA OASIS, CIVIC, CR-V, EV PLUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V027000·2020-01-17

    Honda Recalls Vehicles for Driver Air Bag Inflator Rupture Risk

    Honda is recalling specific 2000-2003 Acura and Honda vehicles because replacement driver air bag inflators may rupture or underinflate in a crash, increasing injury risk.

    Product
    ACURA — ACURA, HONDA MDX, CL, ODYSSEY, RL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V024000·2020-01-17

    Toyota Recalls Corolla, Matrix, Avalon Models for Air Bag Defect

    Toyota is recalling specific 2011-2019 Corolla, Matrix, Avalon, and Avalon Hybrid vehicles because the air bag control unit may malfunction, potentially preventing air bags and seat belt pretensioners from deploying in a crash.

    Product
    TOYOTA — TOYOTA AVALON, AVALON HYBRID, MATRIX, COROLLA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V023000·2020-01-17

    Terex Advance Mixer Recalls 2020 Concrete Mixers Due to Axle Shaft Fracture Risk

    Terex Advance Mixer is recalling 2020 FDC300, FD4000, FD5000GL, and FD7000B vehicles because incorrectly heat-treated axle output shafts may fracture, causing loss of drive and increasing crash risk.

    Product
    TEREX ADVANCE — TEREX ADVANCE FDC300, FD5000GL, FD4000, FD7000B
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V021000·2020-01-16

    Multiquip Recalls 2019 WT5C Trailers Due to Safety Chain Defect

    Multiquip is recalling 119 2019 WT5C trailers because incorrect safety chain attachment points may interfere with steering and increase crash risk.

    Product
    MULTIQUIP — MULTIQUIP WT5C
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0495-2020·2020-01-15

    Reichel Foods Recalls Pro2Snax Snack Trays Due to Listeria Contamination

    Reichel Foods Inc. is recalling Pro2Snax To The Max snack trays due to Listeria monocytogenes contamination. The affected products were distributed nationwide.

    Product
    Pro2Snax To The Max snack tray containing Sliced Apples, Hard Boiled Egg, Mild Cheddar Cheese, and Dried Cranberries & Cashews. Item # 1-4555-6. Net Wt. 7.35 oz (208g) UPC 6 49632-00149 0 Keep Refrigerated.
    Category
    Food
    Distribution
    Distributed nationwide