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.

20926–20950 of 32121

  • SevereFDA (Devices)·Z-0561-2016·2016-01-06

    Beckman Coulter MicroScan Pos Breakpoint Combo Panel Recall

    Beckman Coulter is recalling MicroScan Pos Breakpoint Combo Panel Type 20 due to falsely negative Voges-Proskauer results.

    Product
    MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0445-2016·2016-01-06

    Helados La Tapatia Creamy Fruit Bars Recalled for Unlabeled Eggs

    Helados La Tapatia is recalling Creamy Fruit Bars because the product contains eggs that are not listed on the ingredient label.

    Product
    Helados La Tapatia Creamy Fruit Bars; Chocolate; Net Wt. 3 FL oz; UPC 6 34242 20003 6; INGREDIENTS FOR MILK BARS: ICE CREAM MIX (MILK FAT AND NON FAT MILK. SUGAR, CORN SYRUP. MONO AND DIGLYCERIDES, CELLULOSE GUM, GUAR GUM,POLYSORBATE 80 CARRAGEENAN), WATER…
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0534-2016·2016-01-06

    Walgreens Recalls Dextrose and Sodium Chloride Infusion Bags Due to Sterility Concerns

    Walgreens Infusion Services is recalling Dextrose 5% and 0.45% Sodium Chloride with KCl 20 mEq 1000 mL bags in Texas due to a lack of assurance of sterility.

    Product
    Dextrose 5% and 0.45% Sodium Chloride with KCl 20 mEq 1000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0530-2016·2016-01-06

    Walgreens Recalls Invanz Minibags Due to Sterility Assurance Concerns

    Walgreens Infusion Services is recalling 52 Invanz minibags in Texas due to a lack of assurance of sterility. No illnesses have been reported.

    Product
    Invanz 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0454-2016·2016-01-06

    Helados La Tapatia Granola Ice Milk Bars Recalled for Undeclared Allergens

    Helados La Tapatia is recalling Granola Ice Milk Bars because they contain undeclared soy and almonds.

    Product
    Helados La Tapatia ; Granola; Net Wt. 4 oz, (113g) UPC 6 34242 60012 6; INGREDIENTS FOR ICE MILK BARS: ICE CREAM MIX (CREAM, MILK, FRESH CONDENSED SKIM MILK, SUCROSE, CORN SYRUP. DESSERT SOLIDS (WHEY, REDUCED LACTOSE, WHEY AND NON FAT DRIED MILK) AND STABILIZER ( GUAR…
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0542-2016·2016-01-06

    Walgreens Recalls Thiamine Syringes Due to Sterility Concerns

    Walgreens Infusion Services is recalling 23 Thiamine 100 mg syringes in Texas due to a lack of assurance of sterility.

    Product
    Thiamine 100 mg (1 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0539-2016·2016-01-06

    Walgreens Recalls Ceftriaxone Minibags Due to Sterility Concerns

    Walgreens Infusion Services is recalling 46 minibags of Ceftriaxone 2g/NS 100 mL compounded by Option Care 148 in Texas due to a lack of assurance of sterility.

    Product
    Ceftriaxone 2g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0443-2016·2016-01-06

    Helados La Tapatia Creamy Fruit Bars Recalled for Undeclared Egg Allergen

    Helados La Tapatia is recalling Creamy Fruit Bars because the ice cream mix contains eggs that are not listed on the ingredient label.

    Product
    Helados La Tapatia Creamy Fruit Bars; Natural Creamy All Natural Coconut Coco; Net Wt. 3 FL oz; (85g) UPC 6 34242 20002 9; INGREDIENTS: ICE CREAM MIX MILK, FRESH CONDENSED SKIM MILK, SUCROSE, CORN SYRUP, DESSERT SOLIDS (WHEY, REDUCED LACTOSE WHEY AND. NON FAT DRIED…
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0569-2016·2016-01-06

    BD Vacutainer PLUS K2EDTA Tubes Recalled for Insufficient Additive

    Becton Dickinson is recalling specific lots of BD Vacutainer PLUS K2EDTA tubes because they may contain insufficient EDTA additive, which can lead to erroneous platelet results.

    Product
    BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD BD, Made in USA BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0444-2016·2016-01-06

    Raley's Sweet Pumpkin Ravioli Recalled for Undeclared Cashew and Almond

    Raley's is recalling Sweet Pumpkin Ravioli because it may contain undeclared cashew and almond. The product was distributed in California and Nevada.

    Product
    Raley's Sweet Pumpkin Ravioli; Fresh egg pasta with a pumpkin & Amaretti Biscuits filling. Net Wt. 10 oz. (284 g); Ingredients: Filling- pumpkin, bread crumbs (wheat flour, natural yeast, salt), Butter Amaretti Biscuits (sugar, apricot kernels, egg whites, lactose, milk…
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0442-2016·2016-01-06

    Helados La Tapatia Creamy Fruit Bars Recalled for Unlabeled Eggs

    Helados La Tapatia is recalling Creamy Fruit Bars because the ice cream mix contains eggs that are not listed on the ingredient label.

    Product
    Helados La Tapatia Creamy Fruit Bars; Strawberry Cream flavor; Net Wt. 3 FL oz; UPC 6 34242 20001 2; INGREDIENTS FOR MILK BARS: ICE CREAM MIX (MILK FAT AND NON FAT MILK, SUGAR, CORN SYRUP, MONO AND DIGLYCERIDES, CELLULOSE GUM, GUAR GUM, POLYSORBATE 80, CARRAGEENAN)…
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0540-2016·2016-01-06

    Walgreens Recalls IVIG Gamunex Bags Due to Sterility Concerns

    Walgreens Infusion Services is recalling IVIG Gamunex bags in Texas because the sterility of the product cannot be assured.

    Product
    IVIG Gamunex 40 gm (400 mL) Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0558-2016·2016-01-06

    Walgreens Recalls 3-in-1 TPN Formula Bags Due to Sterility Concerns

    Walgreens Infusion Services is recalling 87 bags of 3-in-1 TPN formula in Texas due to a lack of assurance of sterility.

    Product
    3-in-1 TPN formula daily+overfill Bag, 2000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0533-2016·2016-01-06

    Walgreens Recalls Cefazolin Infusion Bags Due to Sterility Concerns

    Walgreens Infusion Services is recalling specific Cefazolin infusion bags compounded in Texas due to a lack of assurance of sterility.

    Product
    Cefazolin in Accuflo bags, a) 1g/NS 25 mL, b) 2g/NS 25 mL, c) 8g/NS 275 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Lack
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0451-2016·2016-01-06

    Helados La Tapatia Creamy Fruit Bars Recalled for Unlabeled Eggs

    Helados La Tapatia is recalling Creamy Fruit Bars because the ice cream mix contains eggs that are not listed on the ingredient label.

    Product
    Helados La Tapatia Creamy Fruit Bars; Pecan Nuez; Net Wt. 3 FL oz; UPC 6 34242 20007 4; INGREDIENTS FOR MILK BARS: ICE CREAM MIX (MILK FAT AND NON FAT MILK, SUGAR, CORN SYRUP, MONO AND DIGLYCERIDES, CELLULOSE GUM, GUAR GUM, POLYSORBATE 80 CARRAGEENAN), WATER, SUGAR…
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0549-2016·2016-01-06

    Gentamicin Syringes Recalled for Lack of Sterility Assurance

    Walgreens Infusion Services is recalling 27 prefilled Gentamicin syringes in Texas due to a lack of assurance of sterility.

    Product
    Gentamicin 14.4 mg/sodium chloride 0.9% 30 mL Prefilled syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0541-2016·2016-01-06

    Walgreens Recalls Phytonadione Syringes Due to Sterility Concerns

    Walgreens Infusion Services is recalling compounded Phytonadione (Vitamin K) syringes in Texas due to a lack of assurance of sterility.

    Product
    Phytonadione (Vitamin K) 1 mg/0.1mL Syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0547-2016·2016-01-06

    Walgreens Recalls IVIG Gammagard Injection Bags Due to Sterility Concerns

    Walgreens Infusion Services is recalling five bags of IVIG Gammagard injection in Texas due to a lack of assurance of sterility.

    Product
    IVIG Gammagard injection bag, a) 13 gm, b) 20 gm, c) 73 gm, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0557-2016·2016-01-06

    Walgreens Recalls 0.9% Sodium Chloride/MVI Injection Bags Due to Sterility Concerns

    Walgreens Infusion Services is recalling 7 bags of 0.9% Sodium Chloride/MVI injection in Texas due to a lack of assurance of sterility.

    Product
    0.9% Sodium Chloride/MVI injection 2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0537-2016·2016-01-06

    Walgreens Recalls Oxacillin Infusion Bags Due to Sterility Concerns

    Walgreens Infusion Services is recalling 14 bags of compounded Oxacillin 12 g/NS 270 mL due to a lack of assurance of sterility. The product was distributed in Texas.

    Product
    Oxacillin 12 g/NS 270 mL-24 hr Accuflo bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0535-2016·2016-01-06

    Walgreens Infusion Services Recalls 0.9% NaCl Bags Due to Sterility Concerns

    Walgreens Infusion Services is recalling 7 bags of 0.9% NaCl with Ca 4.65 meq in Texas due to a lack of assurance of sterility.

    Product
    0.9% NaCl 1000 mL with Ca 4.65 meq bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0528-2016·2016-01-06

    Walgreens Recalls Vancomycin Injection Bags Due to Sterility Concerns

    Walgreens Infusion Services is recalling 95 bags of Vancomycin Injection in NS due to a lack of assurance of sterility. The affected products were distributed in Texas.

    Product
    Vancomycin Injection in NS, Accuflo bag, a) 500 mg/NS 100 mL, b)1G/NS 100 mL, c) Vancomycin 1G/NS 250 mL, d) 1.5G/NS 250 mL e) 750 mg/NS 100 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0536-2016·2016-01-06

    Meropenem Infusion Minibags Recalled for Sterility Assurance Concerns

    Walgreens Infusion Services is recalling 35 Meropenem minibags distributed in Texas due to a lack of assurance of sterility.

    Product
    Meropenem 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0452-2016·2016-01-06

    Helados La Tapatia Creamy Fruit Bars Recalled for Undeclared Egg Allergen

    Helados La Tapatia is recalling Creamy Fruit Bars because the ice cream mix contains eggs that are not listed on the ingredient label.

    Product
    Helados La Tapatia Creamy Fruit Bars; All Natural Rice Arroz; Net Wt. 3 FL oz; UPC 6 34242 20008 1; INGREDIENTS FOR MILK BARS: ICE CREAM MIX (CREAM, MILK, FRESH CONDENSED SKIM MILK, SUCROSE, CORN SYRUP, DESSERT SOLIDS (WHEY, REDUCED LACTOSE, WHEY AND NON FAT DRIED…
    Category
    Food
    Distribution
    4 states