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.

13701–13725 of 29188

  • SevereFDA (Food)·F-1903-2018·2018-09-05

    Ararat Eggplant Paste Recalled Due to High pH Levels

    Artashes LLC is recalling Ararat Eggplant Paste because FDA inspections found pH levels above the scheduled process.

    Product
    Ararat Eggplant Paste 18.3 oz. glass jar; Ingredients: Eggplants, Red pepper (fresh and grinded), tomato paste, vegetable oil, onion, garlic, carrot, green salt. Product of Armenia; Exclusively imported and distributed by: Kradjian Importing Co., Inc. Glendale…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1153-2018·2018-09-05

    Pharmcore Recalls Ipamorelin Vials Due to Sterility Assurance Concerns

    Pharmcore Inc. is recalling Ipamorelin 3 mg vials because the company cannot ensure the product is sterile.

    Product
    Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1142-2018·2018-09-05

    Torrent Pharma Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity

    Torrent Pharma Inc. is recalling specific lots of Amlodipine, Valsartan, and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-326-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1914-2018·2018-09-05

    Howard Calcagno Farms Recalls Cilantro Due to Cyclospora Contamination Risk

    Howard Calcagno Farms is recalling cilantro shipped in cardboard boxes due to a potential for contamination with Cyclospora cayetanensis. The product was distributed in Oregon.

    Product
    Cilantro was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1135-2018·2018-09-05

    Torrent Pharma Recalls Valsartan Tablets Due to Carcinogen Impurity

    Torrent Pharma Inc. is recalling specific batches of Valsartan Tablets USP, 160mg, because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-069-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1160-2018·2018-09-05

    Auro Pharmacies Recalls Methyl-Cobalamin Injectable Due to Sterility Concerns

    Auro Pharmacies, Inc. is recalling 114 vials of Methyl-Cobalamin injectable because inadequate processes and equipment failed to assure product sterility.

    Product
    Methyl-Cobalamin injectable, 1 mg/mL, packaged in a) 5 mL and b) 30 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V579000·2018-09-05

    Toyota Recalls 2016-2018 Prius Vehicles for Electrical Fire Risk

    Toyota is recalling 2016-2018 Prius vehicles because a worn engine wire harness could cause an electrical short and increase the risk of a fire.

    Product
    TOYOTA — TOYOTA PRIUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1166-2018·2018-09-05

    Auro Pharmacies Recalls Folic Acid Injectable Due to Sterility Concerns

    Auro Pharmacies, Inc. is recalling 40 vials of Folic Acid injectable due to inadequate processes and equipment to assure sterility.

    Product
    Folic Acid injectable, 10 mg/ml, 30 ml Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1150-2018·2018-09-05

    Pharmcore Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns

    Pharmcore Inc. is recalling 3,070 vials of Human Chorionic Gonadotropin 2500 IU due to a lack of assurance of sterility. The recall is nationwide.

    Product
    Human Chorionic Gonadotropin 2500 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1152-2018·2018-09-05

    Pharmcore Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns

    Pharmcore Inc. is recalling 3,351 vials of Human Chorionic Gonadotropin 6000 IU due to a lack of assurance of sterility.

    Product
    Human Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1144-2018·2018-09-05

    Torrent Pharma Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets

    Torrent Pharma Inc. is recalling specific batches of Amlodipine, Valsartan, and Hydrochlorothiazide tablets due to the detection of a carcinogen impurity in the active pharmaceutical ingredient.

    Product
    Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-328-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2941-2018·2018-09-05

    MedComp Recalls DUO FLOW Custom Trays Due to Suture Wing Cracking

    Medical Components, Inc dba MedComp is recalling DUO FLOW Custom Trays because suture wings may crack or break, posing risks of catheter dislocation, bleeding, and air emboli.

    Product
    DUO FLOW CUSTOM TRAYS; TRAY #414 TRAY #415 TRAY #67
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E088000·2018-09-05

    AXN Heavy Duty Recalls Trailer Axles Due to Wheel Separation Risk

    AXN Heavy Duty LLC is recalling certain trailer axles because the wheel end nut locking device may not be properly installed, allowing the wheel end to separate from the axle.

    Product
    SUSPENSION:REAR:AXLE:NON-POWERED AXLE ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1159-2018·2018-09-05

    Auro Pharmacies Recalls Glutathione Injectable Due to Sterility Concerns

    Auro Pharmacies is recalling 183 vials of Glutathione injectable because inadequate processes and equipment were used to assure the sterility of the product.

    Product
    Glutathione injectable, 200 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1905-2018·2018-09-05

    Ararat Cut Beets Recalled Due to High pH Levels

    Artashes LLC is recalling Ararat Cut Beets because FDA inspections found pH levels above the scheduled process.

    Product
    Ararat Cut Beets; 19 oz. glass jar; Ingredients: Cut Beets, Water, Salt, Sugar, Citric Acid. Product of Armenia; Exclusively imported and distributed by: Kradjian Importing Co., Inc. Glendale, CA
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1141-2018·2018-09-05

    Torrent Pharma Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity

    Torrent Pharma Inc. is recalling specific batches of Amlodipine, Valsartan, and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-325-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·074-2018·2018-09-04

    Bahar LLC Recalls Frozen Raw Beef Dumplings Produced Without Inspection

    Bahar LLC is recalling approximately 2,520 pounds of frozen, raw beef dumplings produced without federal inspection. The products were distributed in New Jersey.

    Product
    Bahar, LLC — Bahar LLC Recalls Frozen, Raw Beef Dumpling Products Produced without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·18V578000·2018-08-30

    GM Recalls 2015-2016 Trucks and SUVs for Brake Pedal Nut Issue

    General Motors is recalling 2015-2016 Chevrolet and GMC vehicles because a brake pedal pivot nut may loosen, potentially rendering the brakes inoperative or interfering with the accelerator.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO 1500, SIERRA 3500, SIERRA 2500, SILVERADO 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V581000·2018-08-30

    Daimler Trucks Recalls 2017-2019 Freightliner and Western Star Trucks for Fuel Line Defect

    Daimler Trucks is recalling 2017-2019 Freightliner and Western Star trucks because a restricted fuel pump cooling circuit screen may cause the fuel line to burst, leading to fuel leaks or engine stalling.

    Product
    FREIGHTLINER — FREIGHTLINER, WESTERN STAR 122SD, CASCADIA, CORONADO, 4900
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V576000·2018-08-30

    GM Recalls 2018-2019 Vehicles for Rear Brake Caliper Coating Defect

    General Motors is recalling 2018-2019 Chevrolet, GMC, Buick, and Cadillac vehicles because rear brake caliper pistons may have insufficient coating, potentially reducing braking performance.

    Product
    BUICK — BUICK, CADILLAC, CHEVROLET REGAL, XTS, BOLT EV, IMPALA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V570000·2018-08-30

    Jayco Recalls 2018 Alante Vehicles Due to Hydraulic Hose Fire Risk

    Jayco is recalling 2018 Alante vehicles because damaged leveling system hydraulic hoses may leak fluid onto the exhaust system, increasing the risk of a fire.

    Product
    JAYCO — JAYCO ALANTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·18212·2018-08-30

    PetSmart Recalls Reptile Strip Lights Due to Fire Hazard

    PetSmart is recalling 20-inch and 30-inch reptile strip light fixtures because the bulbs can overheat and ignite the hood, posing a fire hazard.

    Product
    Reptile strip light fixtures
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2843-2018·2018-08-29

    Philips DigitalDiagnost 4.1 Footplate Hook Recall for Injury Risk

    Philips is recalling DigitalDiagnost 4.1 High Performance units because a defective hook allows the footplate to fall or swing, posing an injury risk to operators and patients.

    Product
    DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
    Category
    Medical Device
    Distribution
    Distributed nationwide