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.

10176–10200 of 29157

  • SevereFDA (Food)·F-0574-2020·2020-02-05

    Jeni's Dairy Free Cold Brew Pints Recalled for Undeclared Milk Allergen

    Jeni's Splendid Ice Creams LLC is recalling 49,358 pints of Dairy Free Cold Brew with Coconut Cream frozen dessert because they may contain undeclared milk.

    Product
    Jeni's Dairy Free Cold Brew with Coconut Cream Pints frozen dessert
    Category
    Food
    Distribution
    50 states
  • SevereFDA (Food)·F-0563-2020·2020-02-05

    Whole Foods Recalls Dark Chocolate Peppermint Sandwiches for Undeclared Milk

    Whole Foods Market is recalling 365 Everyday Value Dark Chocolate Peppermint Sandwich Cremes because they may contain undeclared milk.

    Product
    365 Everyday Value Dark Chocolate Peppermint Sandwich Cremes Net Wt 7.75 oz (220g) UPC 9948247605 Paper carton boxes sold individually
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V061000·2020-02-04

    Hyundai Recalls Vehicles Due to ABS Module Fire Risk

    Hyundai is recalling specific Elantra, Elantra Touring, Santa Fe, and Entourage models because moisture in the ABS module can cause an electrical short and engine compartment fire.

    Product
    HYUNDAI — HYUNDAI SANTA FE, ENTOURAGE, ELANTRA, ELANTRA TOURING
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20E003000·2020-02-04

    Cummins Recalls PowerDrive EV Drivetrains for Loss of Drive Power

    Cummins is recalling PowerDrive EV drivetrains for school buses, step vans, and medium-duty trucks because a connector may unplug, causing sudden loss of drive power and power steering.

    Product
    POWER TRAIN recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V060000·2020-01-31

    McElrath Trailers Recalls 2016-2020 Models Due to Frame Weld Cracks

    McElrath Trailers is recalling 2016-2020 VX30-800 and VX50-800 trailers because structural frame welds may crack, increasing crash risk.

    Product
    MCELRATH TRAILERS — MCELRATH TRAILERS VX30-800, VX50-800
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V056000·2020-01-31

    Volkswagen Recalls Audi Vehicles for Driver Air Bag Inflator Defect

    Volkswagen Group of America is recalling specific Audi A8, A4, TT, and A6 models because driver air bag inflators may absorb moisture, potentially causing improper deployment in a crash.

    Product
    AUDI — AUDI A8, A4, TT, A6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V053000·2020-01-30

    Land Rover Recalls 2020 Discovery Models for Seat Frame Defect

    Jaguar Land Rover is recalling 2020 Discovery vehicles because second-row seat frames may lack fasteners, potentially failing to secure occupants in a crash.

    Product
    LAND ROVER — LAND ROVER DISCOVERY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V055000·2020-01-30

    GM Recalls 2019 Silverado and Sierra Trucks for Brake Software Error

    General Motors is recalling 2019 Chevrolet Silverado 1500 and GMC Sierra 1500 trucks because a software error may disable electronic brake assist, increasing crash risk.

    Product
    GMC — GMC, CHEVROLET SIERRA 1500, SILVERADO 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V050000·2020-01-29

    Vactor 2100i Vehicles Recalled for Safety Interlock Software Defect

    Vactor is recalling 2017-2020 2100i vehicles because a software defect may cause safety interlocks to fail, leading to unintentional vehicle movement and increased crash risk.

    Product
    VACTOR — VACTOR 2100I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V049000·2020-01-29

    Forest River Recalls 2020 Recreational Trailers Due to Brake Switch Failure

    Forest River is recalling 218 units of 2020 recreational trailers because a failed break-away switch may prevent brakes from engaging if the trailer separates from the tow vehicle.

    Product
    FOREST RIVER — FOREST RIVER FREEDOM EXPRESS, WILDCAT MAXX, WILDWOOD, SALEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0798-2020·2020-01-29

    RemedyRepack Recalls Ranitidine Tablets Due to Potential NDMA Contamination

    RemedyRepack Inc. is recalling specific lots of Ranitidine 150 mg tablets because the supplier reported potential Nitrosodimethylamine (NDMA) levels above established limits.

    Product
    Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0796-2020·2020-01-29

    Preferred Pharmaceuticals Recalls Ranitidine Tablets Due to NDMA Impurity

    Preferred Pharmaceuticals is recalling 150 mg Ranitidine tablets because of detected NDMA impurity. The affected products were distributed to physicians in seven states.

    Product
    Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottles (NDC: 68788-7388-3), b) 60 count bottles (NDC: 68788-7388-6), c) 90 count bottles (NDC: 68788-7388-9), d) 100 count bottles (NDC: 68788-7388-1)
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0795-2020·2020-01-29

    Denton Pharma Recalls Ranitidine Tablets Due to NDMA Impurity

    Denton Pharma is recalling 467 bottles of Ranitidine Tablets 300 mg because of the presence of NDMA impurity. The affected products were distributed nationwide.

    Product
    Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0800-2020·2020-01-29

    Entropic Labs SARM RAD-140 Recalled for Lack of FDA Approval

    Entropic Labs is recalling SARM RAD-140 capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Entropic Labs SARM RAD-140, 20mg Capsules, 30-count bottles, Entropic Labs UPC#: 651074545302
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0791-2020·2020-01-29

    Mylan Recalls Nizatidine Capsules Due to NDMA Impurity Detection

    Mylan Pharmaceuticals is recalling Nizatidine Capsules 150 mg because trace amounts of the impurity NDMA were detected in the active ingredient.

    Product
    Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0794-2020·2020-01-29

    Denton Pharma Recalls Ranitidine Tablets Due to NDMA Impurity

    Denton Pharma is recalling 1,341 bottles of Ranitidine Tablets 150 mg because the product was found to contain the NDMA impurity.

    Product
    Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC 70934-017-90), Rx Only, Repackaged by: Northwind Pharmaceuticals
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0525-2020·2020-01-29

    AQUABEST Sea Mart Frozen Yellowfin Tuna Recalled for Histamine Levels

    AQUABEST SEAFOOD LLC is recalling Sea Mart Frozen Yellowfin Tuna Saku due to potentially elevated histamine levels linked to a recent poisoning outbreak.

    Product
    Sea Mart Frozen Yellowfin Tuna Saku, CO treated, skinless, boneless, bloodline removed, 10-12oz, 10 lb package
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0523-2020·2020-01-29

    Sea Mart Frozen Yellowfin Tuna Steak Recalled for Histamine Levels

    AQUABEST SEAFOOD LLC is recalling Sea Mart Frozen Yellowfin Tuna Steak due to potentially elevated histamine levels linked to a poisoning outbreak.

    Product
    Sea Mart Frozen Yellowfin Tuna Steak, CO treated, skinless, boneless, bloodline removed, 8 oz, 10lb package
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0792-2020·2020-01-29

    Mylan Recalls Nizatidine Capsules Due to NDMA Impurity Detection

    Mylan Pharmaceuticals is recalling Nizatidine Capsules 300 mg because trace amounts of the impurity NDMA were detected in the active ingredient.

    Product
    Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0797-2020·2020-01-29

    Preferred Pharmaceuticals Recalls Ranitidine Tablets Due to NDMA Impurity

    Preferred Pharmaceuticals is recalling Ranitidine Tablets, 300 mg, because the presence of the NDMA impurity was detected in the product.

    Product
    Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 count bottles (NDC: 68788-6382-1), b) 30 count bottles (NDC: 68788-6382-3), c) 90 count bottles (NDC: 68788-6382-9), d) 100 count bottles (NDC: 68788-6382-0)
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Food)·F-0524-2020·2020-01-29

    AQUABEST Seafood Recalls Frozen Yellowfin Tuna Loin Due to Histamines

    AQUABEST SEAFOOD LLC is recalling 9,630 lbs of Sea Mart Frozen Yellowfin Tuna Loin due to potentially elevated histamine levels linked to a recent poisoning outbreak.

    Product
    Sea Mart Frozen Yellowfin Tuna Loin, CO treated, skinless, boneless, bloodline removed, center cut 5-8 lbs, 30 lb package
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0793-2020·2020-01-29

    Ranitidine Tablets Recalled Due to NDMA Impurity Detection

    H.J. Harkins Company is recalling specific lots of Ranitidine 150 mg tablets because NDMA impurity was detected. The product was distributed to physicians in four states.

    Product
    Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count; Rx, Only, H.J. Harkins Company, Inc. dba Pharma Pac Grover Beach, CA 93433 NDC #s: 52959-0502-07, 52959-0502-14, 52959-0502-20, 52959-0502-30 and 52959-0502-60
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0842-2020·2020-01-29

    Palodex Dental X-Ray Imagers Recalled for Power Supply Fire Risk

    Palodex Group Oy is recalling Instrumentarium Dental Express X-ray imagers because slow degradation of plastic insulation in the power supply unit may cause short circuits, heating, and smoke.

    Product
    Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
    Category
    Medical Device
    Distribution
    2 states