The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

35501–35525 of 50504

  • HighFDA (Drugs)·D-0986-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls Sterility-Compromised Glutathione Vials

    Well Care Compounding Pharmacy is recalling 869 vials of Glutathione 100mg/mL due to FDA-identified GMP violations that may compromise sterility.

    Product
    GLUTATHIONE 100MG/ML, packaged in 10 mL vials, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1022-2016·2016-06-15

    Vancomycin Ophthalmic Solution Recalled for Sterility Assurance Concerns

    Well Care Compounding Pharmacy is recalling Vancomycin 50mg/mL ophthalmic solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    VANCOMYCIN 50MG/ML OPHTH SOLUTION; packaged in 10mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1001-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls Methylcobalamin Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling Methylcobalamin 5mg/mL vials because FDA inspections found GMP violations that may affect sterility.

    Product
    METHYLCOBALAMIN 5MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1937-2016·2016-06-15

    Becton Dickinson Recalls 10 mL Syringes Due to Manufacturing Non-Conformities

    Becton Dickinson is recalling 811,200 units of 10 mL syringes due to possible adulteration and non-conforming manufacturing practices.

    Product
    Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0998-2016·2016-06-15

    FDA Recalls Well Care Compounding Pharmacy M.l.C./B5/B6 Injection for Sterility Concerns

    Well Care Compounding Pharmacy is recalling M.l.C./B5/B6 injection vials due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    M.l.C./B5/B6 25 MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0993-2016·2016-06-15

    FDA Recalls Compounded L-Glutamine Injection Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling compounded L-Glutamine/L-Arginine/L-Carnitine injections due to FDA inspection findings regarding sterility assurance.

    Product
    L-GLUT/L-ARG/L-CARN; 25MG/100MG/200MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • HighNHTSA·16V438000·2016-06-15

    Mercedes-Benz Recalls 2016 C300 Vehicles for Steering Software Error

    Mercedes-Benz is recalling 2016 C300 4Matic vehicles because a software error may cause the electric power steering assist system to shut down, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ C300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1691-2016·2016-06-15

    Sedecal Mobile X-ray System Recalled for Software Defect

    Sedecal USA is recalling 145 mobile x-ray systems in the US due to a software defect that may apply adult exposure parameters to newborns.

    Product
    Sedecal SA Mobile Diagnost w DR x-ray system
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Food)·F-1429-2016·2016-06-15

    Bakery Express Recalls 7-Eleven Peanut Butter Cookies for Undeclared Peanut

    Bakery Express is recalling 7-Eleven Fresh To Go Peanut Butter Cookies sold in Florida due to an undeclared peanut allergen.

    Product
    7-Eleven Fresh To Go Peanut Butter Cookie Net Wt 4.0 oz (114g). Manufactured by Bakery Express in Orlando, FL.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1936-2016·2016-06-15

    Becton Dickinson Recalls 10 mL Syringes Due to Manufacturing Issues

    Becton Dickinson is recalling 176,000 units of 10 mL syringes due to possible adulteration and non-conforming manufacturing practices.

    Product
    Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1713-2016·2016-06-15

    Philips Brilliance 64 CT System Software Defect Recall

    Philips Healthcare is recalling 423 Brilliance 64 CT systems in the US due to software defects causing incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Brilliance 64 Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • HighNHTSA·16V439000·2016-06-15

    Mercedes-Benz Recalls 2016 SLK and SL Models for Headlight Aim

    Mercedes-Benz is recalling certain 2016 SLK and SL models because low-beam headlights may be aimed incorrectly, potentially reducing driver visibility.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SLK300, SL63, SL550, SLK350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16197·2016-06-15

    Sony Recalls VAIO Laptop Battery Packs Due to Fire and Burn Hazards

    Sony is recalling Panasonic lithium-ion battery packs for VAIO laptops because they can overheat, posing burn and fire hazards. No injuries have been reported.

    Product
    Panasonic battery packs used in Sony Electronics laptop computers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1008-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls QUAD-MIX #4 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling QUAD-MIX #4 (MOD) vials because FDA inspections found violations that may affect product sterility.

    Product
    QUAD-MIX #4 (MOD), packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0995-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls M.I.C. Injection Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling M.I.C. /MB12/B6/DEXPLAN/L-CARN injection vials because FDA inspections found GMP violations that may affect sterility.

    Product
    M.I.C. /MB12/B6/DEXPLAN/L-CARN, 25MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1028-2016·2016-06-15

    FDA Recalls Itraconazole Nasal Spray Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling Itraconazole/Mupirocin/Triamcinolone nasal spray because FDA inspections found GMP violations that may affect sterility.

    Product
    ITRACONAZOLE 0.2%/MUPIROCIN 0.2%/TRIAMCINOLONE 0.03% NASAL SPRAY, 15mL bottle, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • HighNHTSA·16V436000·2016-06-15

    Nissan Recalls 2016 Leaf and Sentra for Passenger Air Bag Wiring Defect

    Nissan is recalling specific 2016 Leaf and Sentra vehicles because a wiring harness connector may disconnect, preventing the passenger air bag from deploying in a crash.

    Product
    NISSAN — NISSAN LEAF, SENTRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1417-2016·2016-06-15

    Werner Butter Toffee Peanuts Recalled for Undeclared Milk Allergen

    Werner Gourmet Meat Snacks, Inc. is recalling Werner Brand Butter Toffee Peanuts because the labels declared butter but failed to declare milk as an ingredient.

    Product
    Werner Brand Butter Toffee Peanuts, net wt. 2.25 oz, UPC 7 09972 80113 3 Werner Brand Butter Toffee Peanuts, net wt. 6 oz., UPC 7 09972 80027 3 The ingredients statement declared: Peanuts, Sugar, Butter, Salt. The label contains an advisory statement Allergen…
    Category
    Food
    Distribution
    19 states
  • HighFDA (Drugs)·D-0979-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls Alpha Lipoic Acid Vials for Sterility Concerns

    Well Care Compounding Pharmacy is recalling Alpha Lipoic Acid 25mg/mL vials due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    ALPHA LIPOIC ACID 25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1926-2016·2016-06-15

    Medtronic RestoreSensor Implantable Neurostimulators Recalled for Battery Depletion

    Medtronic is recalling RestoreSensor implantable neurostimulators because insufficient coupling during recharging can cause rapid battery depletion and loss of therapy.

    Product
    Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators. Used to treat chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0981-2016·2016-06-15

    FDA Recalls Estradiol Cypionate Vials Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling Estradiol Cypionate 10 mg/mL vials because FDA inspections found GMP violations that may affect sterility.

    Product
    ESTRADIOL CYPIONATE 10 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-1437-2016·2016-06-15

    Frozen Inc. Recalls German Chocolate Dessert Bar Cake for Missing Pecan Labeling

    Frozen Inc. is recalling 24 oz German Chocolate Dessert Bar Cakes because the product does not list pecans on the label.

    Product
    24 oz RM German Choc. Dessert Bar Cake. Net Wt: 24 oz, K Dairy, UPC 752716883308, Vollmer's Bakery - 4004 Grape Street - Denver, CO - 303-388-8393. Packaging: Plastic Container, 8 per case, Keep frozen, refrigerate after opening.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1833-2016·2016-06-15

    Hospira Recalls 2,567 Plum A+ Infusion Pumps Due to Calibration Error

    Hospira is recalling 2,567 Plum A+ infusion pumps because a calibration error caused false occlusion alarms. The devices were distributed in the U.S. and 13 foreign countries.

    Product
    The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With its primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for…
    Category
    Medical Device
    Distribution
    0 states