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.

10501–10525 of 29158

  • SevereFDA (Drugs)·D-0558-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl Syringes Due to Glass Particulate Matter

    QuVa Pharma is recalling fentanyl 50 mcg/mL syringes because of potential glass particulate matter. The recall covers multiple lots distributed nationwide.

    Product
    fentaNYL 2750 mcg/55 mL (50 mcg/mL) 55 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1100-50
    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 (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-0559-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl and Bupivacaine Infusions Due to Particulate Matter

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

    Product
    fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1255-75
    Category
    Drug
    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-0551-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl Syringes Due to Glass Particulate Matter

    QuVa Pharma is recalling fentanyl syringes due to the potential presence of glass particulate matter. The recall is classified as FDA Class II.

    Product
    fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1099-49
    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
  • 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-0544-2020·2019-12-11

    Sanofi Recalls Zantac 150 mg Tablets Due to NDMA Impurity

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

    Product
    Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 66715-9736-2 66715-9736-3 66715-9736-8
    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 (Food)·F-0213-2020·2019-12-11

    Vinyard Fruit & Vegetable Recalls 7109 Veg Kit for Listeria Risk

    Vinyard Fruit & Vegetable Co., Inc. is recalling 7109 Veg Kit products due to potential contamination with Listeria monocytogenes.

    Product
    7109 Veg Kit, (Broc, Caul, Carr, Cele) 4/3# packaged in plastic flexible bags
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·19V880000·2019-12-11

    Ford Recalls 2017-2019 Super Duty Trucks for Fire Risk

    Ford is recalling 2017-2019 F-Super Duty trucks because seat belt pretensioner sparks could ignite B-pillar materials, potentially causing a vehicle fire.

    Product
    FORD — FORD F-250 SD, F-550 SD, F-350 SD, F-450 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0563-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl Infusion Bags Due to Glass Particulate Matter

    QuVa Pharma is recalling specific lots of fentanyl infusion bags due to the presence of glass particulate matter.

    Product
    fentaNYL 2000 mcg/100 mL (20 mcg/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 70092-1094-36
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0547-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl and Bupivacaine Bags Due to Particulate Matter

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

    Product
    fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1105-37
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0545-2020·2019-12-11

    Sanofi Recalls Zantac 75 mg Tablets Due to NDMA Impurity

    Sanofi-Aventis U.S. LLC is recalling Zantac 75 mg tablets nationwide because NDMA impurity was detected. The recall covers all lots of the product.

    Product
    Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 0597-0122-01 0597-0122-08 0597-0122-13 0597-0122-37 0597-0122-40 0597-0122-54 0597-0122-61 0597-0122-81 0597-0122-96
    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-0572-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl Syringes Due to Glass Particulate Matter

    QuVa Pharma is recalling fentanyl 550 mcg/55 mL syringes due to the presence of glass particulate matter.

    Product
    fentaNYL 550 mcg/55 mL (10 mcg/mL) in 0.9% Sodium Chloride 55 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1274-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0609-2020·2019-12-11

    Lens.com Recalls Alcon Air Optix Night & Day Aqua Contact Lenses

    Lens.com is recalling specific lots of Alcon Air Optix Night & Day Aqua contact lenses because they may be counterfeit and have microbial issues.

    Product
    Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
    Category
    Medical Device
    Distribution
    0 states
  • 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-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 (Food)·F-0226-2020·2019-12-11

    Givaudan Recalls Nat Maple Flavor Due to Metal Contamination

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

    Product
    Nat Maple Flavor WONF, 20.412 kg in each 6 gallon blue HDPE jerri-can, UPC: 20357342262
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0562-2020·2019-12-11

    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 particulate matter.

    Product
    fentaNYL 400 mcg/200 mL (2 mcg/mL) 0.1% ROPivacaine HCl 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride , 200 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1207-37
    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
  • SevereUSDA FSIS·119-2019·2019-12-10

    Ruiz Recalls Frozen Breakfast Burritos Due to Plastic Contamination

    Ruiz Food Products is recalling approximately 55,013 pounds of frozen breakfast burritos that may contain pieces of plastic. No injuries have been reported.

    Product
    Ruiz Food Products, Inc. — Ruiz Food Products, Inc. Recalls Frozen Sausage Breakfast Burrito Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide