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.

10476–10500 of 29158

  • SevereNHTSA·19V888000·2019-12-12

    GM Recalls 2019-2020 Silverado and Sierra Trucks for Electrical Fire Risk

    General Motors is recalling 2019-2020 Chevrolet Silverado 1500 and GMC Sierra 1500 trucks because excessive glue on the battery cable may cause electrical arcing, stalling, or fire.

    Product
    GMC — GMC, CHEVROLET SIERRA 1500, SILVERADO 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0556-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl Injection Due to Glass Particulate Matter

    QuVa Pharma is recalling fentanyl 100 mcg/2 mL injections because of potential glass particulate matter. The recall covers specific lots distributed nationwide.

    Product
    fentaNYL 100 mcg/2 mL (50 mcg/mL) Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1097-43
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0552-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl and Ropivacaine Bags Due to Particulate Matter

    QuVa Pharma is recalling specific lots of fentanyl and ropivacaine injection bags due to the presence of particulate matter, including potential glass particles.

    Product
    fentaNYL 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) in 0.9% Sodium Chloride 250 mL Bag Rx, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1225-37
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0549-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl and Bupivacaine IV Bags Due to Particulate Matter

    QuVa Pharma is recalling fentanyl and bupivacaine IV bags due to the presence of particulate matter, specifically potential glass particles.

    Product
    fentaNYL 500 mcg/250 mL (2 mcg/mL) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (0.625 mg/mL) in 0.9% Sodium Chloride in 250 mL Bag, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1269-37
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0538-2020·2019-12-11

    GE Healthcare Recalls Giraffe OmniBed Infant Warmers Due to Latch Defect

    GE Healthcare is recalling Giraffe OmniBed infant warmers because bedside panels and portholes may appear closed without being latched, posing a risk of patient falls.

    Product
    Giraffe OmniBed infant warmer
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0215-2020·2019-12-11

    Vinyard Fruit & Vegetable Recalls Mixed Vegetables for Listeria Risk

    Vinyard Fruit & Vegetable Co. is recalling 1,066 cases of 3570 Mix, TEDs Vegetable due to potential Listeria monocytogenes contamination.

    Product
    3570 Mix, TEDs Vegetable 4/5# Ingredients: Broccoli - Carrot - Zucchini - Yellow Squash packaged in plastic flexible bags
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0564-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl and Ropivacaine Infusions Due to Particulate Matter

    QuVa Pharma is recalling specific lots of fentanyl and ropivacaine infusions due to the potential presence of glass particulate matter.

    Product
    fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride 200 mL CADD, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1441-76
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0568-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl and Bupivacaine Infusion Due to Glass Particulates

    QuVa Pharma is recalling specific lots of a fentanyl and bupivacaine infusion due to the presence of glass particulates.

    Product
    fentaNYL 800 mcg/200 mL (4 mcg/mL) BUPivacaine HCl 0.1667% 333.4 mg/200 mL (1.667 mg/mL) in 0.9% Sodium Chloride 200 mL in 250 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0567-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl Injection Bags Due to Glass Particulates

    QuVa Pharma is recalling fentanyl injection bags due to the potential presence of glass particulates.

    Product
    fentaNYL 1250 mcg/250 mL (5 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1444-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0570-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl PCA Vials Due to Glass Particulate Matter

    QuVa Pharma is recalling specific lots of fentanyl PCA vials due to the potential presence of glass particulate matter.

    Product
    fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vial Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1180-79
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0542-2020·2019-12-11

    Sanofi Recalls Regular Strength Zantac 75 mg Due to NDMA Impurity

    Sanofi-Aventis U.S. LLC is recalling Regular Strength Zantac 75 mg tablets because the FDA detected the NDMA impurity in the product.

    Product
    Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 67751-152-01 67751-152-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0569-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl Bags Due to Glass Particulate Matter

    QuVa Pharma is recalling specific lots of fentanyl 2500 mcg/50 mL bags nationwide due to the presence of glass particulate matter.

    Product
    fentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V879000·2019-12-11

    Volkswagen Recalls 2019 Jetta and Golf Models for Wheel Bearing Defect

    Volkswagen is recalling 2019 Jetta GLI, Golf Alltrack, and Golf GTI vehicles because improperly machined front wheel bearings may cause excessive stress, increasing the risk of a crash.

    Product
    VOLKSWAGEN — VOLKSWAGEN JETTA, GOLF ALLTRACK, GOLF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0546-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl and Bupivacaine Bags Due to Particulate Matter

    QuVa Pharma is recalling fentanyl and bupivacaine injection bags due to the presence of particulate matter, specifically potential glass particles.

    Product
    fentaNYL 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx only, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1160-37
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0541-2020·2019-12-11

    Sanofi Recalls Zantac 150 mg Tablets Due to NDMA Impurity

    Sanofi-Aventis U.S. LLC is recalling Regular Strength Zantac 150 mg tablets nationwide because an NDMA impurity was detected. This action addresses current good manufacturing practice (CGMP) deviations.

    Product
    Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 67751-151-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0535-2020·2019-12-11

    Sanofi Recalls Zantac 75 mg Tablets Due to NDMA Impurity

    Sanofi-Aventis U.S. LLC is recalling Regular Strength Zantac 75 mg tablets nationwide because NDMA impurity was detected. This action addresses CGMP deviations.

    Product
    Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's 41167-0300-0, 41167-0300-1, 41167-0300-3, 41167-0300-5, 41167-0300-6, 41167-0300-7, 41167-0300-8
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0537-2020·2019-12-11

    Sanofi Recalls Regular Strength Zantac 150 mg Due to NDMA Impurity

    Sanofi-Aventis U.S. LLC is recalling Regular Strength Zantac 150 mg because the FDA detected the NDMA impurity in the product.

    Product
    Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 05269-220-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0209-2020·2019-12-11

    Hummingbird Wholesale Organic Chia Seeds Recalled for Metal Contamination

    Honey Heaven Wholesale Inc is recalling Hummingbird Wholesale Organic Chia Seeds due to a metal bar found in the product. The metal bar had a jagged edge and loose flakes.

    Product
    Hummingbird Wholesale Organic Chia Seeds, SD120-5#, packaged in a clear plastic bag with a while label, net wt. 5 lbs. No UPC code.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0227-2020·2019-12-11

    Givaudan Recalls Strawberry Banana Flavor Due to Metal Contamination

    Givaudan Flavours Corp is recalling Nat Strawberry Banana Flavor WONF because metal material was found in a raw ingredient used during production.

    Product
    Nat Strawberry Banana Flavor WONF, 20.412 kg in each 6 gallon blue HDPE jerri-can, UPC: 20358212722
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0534-2020·2019-12-11

    Sanofi Recalls Zantac Tablets Due to NDMA Impurity

    Sanofi is recalling Cool Mint Tablets Maximum Strength Zantac 150 mg nationwide because NDMA impurity was detected in the product.

    Product
    Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0120-06, 0597-0120-08, 0597-0120-09, 0597-0120-24, 0597-0120-38, 0597-0120-50, 0597-0120-76, 0597-012
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0538-2020·2019-12-11

    Sanofi Recalls Zantac 150 mg Tablets Due to NDMA Impurity

    Sanofi-Aventis U.S. LLC is recalling Cool Mint Maximum Strength Zantac 150 mg tablets nationwide because an NDMA impurity was detected.

    Product
    Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's: 41167-0320-1 41167-0320-2 41167-0320-3 41167-0320-4 41167-0320-5 41167-0320-6 41167-0320-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0543-2020·2019-12-11

    Sanofi Recalls Zantac 75 mg Due to NDMA Impurity

    Sanofi is recalling Regular Strength Zantac 75 mg tablets nationwide because an NDMA impurity was detected in the product.

    Product
    Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 68151-2584-0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0539-2020·2019-12-11

    Sanofi Recalls Maximum Strength Zantac 150 mg Due to NDMA Impurity

    Sanofi-Aventis U.S. LLC is recalling Maximum Strength Zantac 150 mg tablets nationwide because the FDA detected the NDMA impurity in the product.

    Product
    Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0121-01, 0597-0121-06, 0597-0121-08, 0597-0121-09, 0597-0121-11, 0597-0121-24, 0597-0121-38, 0597-0121-50, 0597-0121-64, 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0561-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl and Ropivacaine Bags Due to Glass Particulates

    QuVa Pharma is recalling specific lots of fentanyl and ropivacaine injection bags due to the presence of glass particulates.

    Product
    fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride , 100 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1108-36
    Category
    Drug
    Distribution
    Distributed nationwide