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.

17076–17100 of 29206

  • SevereNHTSA·16V944000·2016-12-29

    Glacier Recalls 2016 RV Explorers Due to Axle Bolt Defect

    Glacier is recalling 38 model year 2016 RV Explorer trailers because a short axle bolt may fail, causing the wheel assembly to detach and increasing crash risk.

    Product
    GLACIER — GLACIER RV EXPLORER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V942000·2016-12-29

    Land Rover Recalls Vehicles for Defective Seatbelt Pretensioners

    Jaguar Land Rover is recalling 2016-2017 Range Rover, Range Rover Sport, and 2017 Discovery Sport vehicles because front seatbelt pretensioners may not function properly in a crash.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER, RANGE ROVER SPORT, DISCOVERY SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V943000·2016-12-29

    Jaguar Recalls 2016-2017 XJ Models Due to Air Bag Defect

    Jaguar is recalling 2016-2017 XJ vehicles because the front passenger air bag may fail to deploy in a crash. Dealers will replace the air bag free of charge.

    Product
    JAGUAR — JAGUAR XJ
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V955000·2016-12-29

    Volkswagen and Audi Recall Vehicles for Air Bag and Seat Belt Defects

    Volkswagen Group of America is recalling specific 2016-2018 Audi and Volkswagen models because air bags or seat belt pretensioners may not function properly in a crash.

    Product
    VOLKSWAGEN — VOLKSWAGEN, AUDI E-GOLF, A4 ALLROAD, GOLF, Q7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0729-2017·2016-12-28

    Woodland Foods Salt-Free Roasted Sunflower Seeds Recalled for Listeria

    Woodland Foods is recalling salt-free roasted sunflower seeds potentially contaminated with Listeria. The product was distributed to food distributors in 25 states.

    Product
    Product is packaged into a plastic bag and placed into cardboard box. Product is labeled as "N34D SALT-FREE ROASTED SUNFLOWER SEEDS".
    Category
    Food
    Distribution
    25 states
  • SevereFDA (Food)·F-0773-2017·2016-12-28

    Wakefern Recalls 24-Pack Red Velvet Cookies for Metal Pieces

    Wakefern Food Corp. is recalling 24-pack Gourmet Red Velvet Cookies because they may contain metal pieces. The product was distributed in six states.

    Product
    24 pack Gourmet Red Velvet Cookies Net WT. 30 oz. UPC 28977400000
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0215-2017·2016-12-28

    Impax Recalls Lamotrigine Tablets Due to Labeling Mixup

    Impax Laboratories is recalling 3,074 boxes of Lamotrigine Orally Disintegrating Tablets because some 200 mg boxes contained 100 mg tablets.

    Product
    Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by: Impax Generics, Hayward, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0214-2017·2016-12-28

    Virtus Recalls Hyoscyamine Sulfate Tablets Due to Potency Failures

    Virtus Pharmaceuticals is recalling 24,444 bottles of Hyoscyamine Sulfate tablets because they failed content uniformity specifications, resulting in inconsistent drug potency.

    Product
    Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-308-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0810-2017·2016-12-28

    Oscor Breezeway Sheath Recalled Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling 255 Breezeway sheaths because a fragment of the inner liner detached during insertion, posing a risk of injury.

    Product
    OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-0866-2017·2016-12-28

    Northgate Technologies Recalls Laparoscopic Insufflators Due to Overpressure Risk

    Northgate Technologies is recalling 49 laparoscopic insufflators because they may cause patient overpressure without visual or auditory warnings.

    Product
    Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used…
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Food)·F-0902-2017·2016-12-28

    Simply Fresh Fruit Recalls Cantaloupe and Fruit Mixes Due to Listeria Risk

    Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.

    Product
    **1) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC #5075810 8449874; **2) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC #50758108449904; **3) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449874 ; **4) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449874 ; **5) 1 GL CVF FRUIT SALAD…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0219-2017·2016-12-28

    US Compounding Recalls Docusate Oral Syringes Due to B. cepacia Contamination

    US Compounding Inc is recalling 10,665 Docusate Oral 10 mg/mL syringes distributed in Texas due to microbial contamination with B. cepacia.

    Product
    Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295-0601-02), and c) 5 mL syringes (62295-0601-05), US Compounding, Conway, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0226-2017·2016-12-28

    Amgen Recalls Kyprolis Vials Due to Potential Glass Cracks

    Amgen is recalling 11,434 vials of Kyprolis (carfilzomib) injection because potential cracks in the glass vials may compromise sterility.

    Product
    KYPROLIS — KYPROLIS (CARFILZOMIB)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0726-2017·2016-12-28

    Woodland Foods Recalls Salt-Free Roasted Sunflower Seeds for Listeria Risk

    Woodland Foods is recalling D'Allesandro Salt-Free Roasted Sunflower Seeds due to potential Listeria contamination. The product was distributed to food distributors in 26 states.

    Product
    Product is packaged into a plastic bag and placed into cardboard box. Product is labeled as "D'ALLESANDRO SALT-FREE ROASTED SUNFLOWER SEEDS". Product was packaged into 5 & 40 lb boxes.
    Category
    Food
    Distribution
    25 states
  • SevereFDA (Drugs)·D-0222-2017·2016-12-28

    3rd Degree Capsules Recalled for Undeclared Sibutramine

    Making It a Lifestyle is recalling 3rd Degree capsules because they contain undeclared sibutramine and were marketed without an approved NDA or ANDA.

    Product
    3rd DEGREE capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0213-2017·2016-12-28

    Virtus Recalls Hyoscyamine Sulfate Tablets Due to Content Uniformity Failures

    Virtus Pharmaceuticals is recalling Hyoscyamine Sulfate tablets because they failed content uniformity specifications, resulting in both superpotent and subpotent doses.

    Product
    Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-307-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0208-2017·2016-12-28

    Colonia Care Pharmacy Recalls Injectable Drug Products Due to Sterility Concerns

    Colonia Care Pharmacy is recalling C-PAV/PHENTOL/PGE1 injectable drug products due to lack of assurance of sterility. The recall affects products distributed in New Jersey and New York.

    Product
    C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-0942-2017·2016-12-28

    Interbake Foods Recalls Girl Scout Peanut Butter Sandwiches Due to Aflatoxin

    Interbake Foods is recalling Girl Scout Peanut Butter Sandwiches because a single lot of peanut butter used contained elevated aflatoxin levels.

    Product
    Girl Scout Peanut Butter Sandwich, NET WT 8 0Z (227 g). UPC 0 20200 07007 8, ABC Bakers/Interbake Foods LLC, Richmond, VA 23233.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0777-2017·2016-12-28

    Wakefern Recalls Chocolate Dipped Cookies Due to Metal Pieces

    Wakefern Food Corp. is recalling Gourmet Chocolate Dipped Cookies because they may contain metal pieces. The product was distributed in six states.

    Product
    Gourmet Chocolate Dipped Cookies Net Wt. 46 oz UPC 269969414994
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0766-2017·2016-12-28

    Chaos and Pain Recalls Cannibal Ferox Amped Pre-Workout Supplement

    Chaos and Pain is recalling its Cannibal Ferox Amped pre-workout supplement because it contains an undeclared prohibited substance.

    Product
    CANNIBAL FEROX AMPED, FACE-MELTING NOOTROPIC, PRE-WORKOUT ENERGY COMPLEX, STRAWBLOODY KIWI CRUSH, DIETARY SUPPLEMENT, NET. WT. 9.9 OZ (280g), Chaos and Pain, UPC 1056331460
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0762-2017·2016-12-28

    Naturecom Recalls DMAA Powder Due to Potential Presence of 1,3-Dimethylamylamine

    Naturecom is recalling 500g bags of DMAA powder because the product may contain 1,3-dimethylamylamine. The recall covers products distributed nationwide and internationally.

    Product
    DMAA (1,3-Dimethylamylamine) Net Weight 500g Product is packaged in approximately 8" x 11 silver and clear mylar ziplock bags that contain 500g of DMAA.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0768-2017·2016-12-28

    Coliman Pacific Recalls Jalapeno Peppers Due to Salmonella Contamination Risk

    Coliman Pacific Corp is recalling jalapeno peppers because they may be contaminated with Salmonella. The affected product was distributed in California and Arizona.

    Product
    Jalapeno Peppers, 40lbs (19 kg) per case, 1 1/9 Bushel Box, 49 cases per pallet
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0782-2017·2016-12-28

    FDA Recalls Ultroid Hemorrhoid Management Systems for Quality System Deficiencies

    The FDA is recalling Ultroid Hemorrhoid Management Systems because they were not manufactured under required quality system controls.

    Product
    Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes
    Category
    Medical Device
    Distribution
    34 states