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.

24426–24450 of 32189

  • SevereFDA (Food)·F-0554-2015·2014-12-03

    Safeway Almond Butter Recalled for Potential Salmonella Contamination

    nSpired Natural Foods is recalling Safeway Open Nature Creamy Almond Butter Salted due to potential Salmonella contamination. The product was distributed in the US, Canada, and other international locations.

    Product
    Safeway Open Nature Creamy Almond Butter Salted, 12 oz., UPC 79893113746
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0281-2015·2014-12-03

    Hospira Recalls Lactated Ringer's and 5% Dextrose Injection Bags

    Hospira is recalling 275,448 bags of Lactated Ringer's and 5% Dextrose Injection due to potential punctures that may compromise sterility and cause leaks.

    Product
    Lactated Ringer's and 5% Dextrose Injection, USP; 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7929-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0269-2015·2014-12-03

    Perry Drug Recalls HCG Injections Due to Sterility Assurance Concerns

    Perry Drug Inc. is recalling HCG 10,000 U/10 mL PF Inj vials in Kansas and Missouri due to quality control issues affecting sterility assurance.

    Product
    HCG 10,000 U/ 10 mL PF Inj, 8Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5012-34
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0267-2015·2014-12-03

    Perry Drug Recalls HCG Vials Due to Sterility Assurance Concerns

    Perry Drug Inc. is recalling HCG Low Dose vials in Kansas and Missouri due to quality control issues affecting sterility assurance.

    Product
    HCG Low Dose 10 IU / 0.1 mL, 5 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-2596-17
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-0572-2015·2014-12-03

    Karlsburger Foods Taco Seasoning Recalled for Undeclared Milk Allergen

    Karlsburger Foods is recalling specific items of Taco Seasoning because the product contains milk, an allergen not declared on the label.

    Product
    Karlsburger Foods Taco Seasoning, Item Numbers 43823 (Packaged in 23 oz resealable plastic containers), Item #43807 (Packaged in 7 lb. resealable plastic containers), Item #43825 (Packaged in 25 lb. bag in a box), and Item #43850 (Packaged in 50 lb. bag in a box).
    Category
    Food
    Distribution
    16 states
  • SevereFDA (Drugs)·D-0286-2015·2014-12-03

    Hospira Recalls 0.45% Sodium Chloride Injection Due to Sterility Concerns

    Hospira is recalling 784,920 bags of 0.45% Sodium Chloride Injection because punctures in the packaging may compromise sterility and cause leaks.

    Product
    0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7985-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0282-2015·2014-12-03

    Hospira Recalls 5% Dextrose and 0.9% Sodium Chloride Injection Bags

    Hospira is recalling 340,272 bags of 5% Dextrose and 0.9% Sodium Chloride Injection due to potential punctures that may compromise sterility and cause leaks.

    Product
    5% Dextrose and 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7941-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V770000·2014-12-03

    Chrysler Recalls 2004-2005 Vehicles Due to Air Bag Inflator Rupture Risk

    Chrysler is recalling 2004-2005 Dodge and Chrysler vehicles sold in high-humidity areas because the passenger air bag inflator may rupture during deployment.

    Product
    DODGE — DODGE, CHRYSLER RAM 3500, RAM 2500, MAGNUM, DURANGO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0283-2015·2014-12-03

    Hospira Recalls Lactated Ringer's Injection Due to Sterility Concerns

    Hospira is recalling 6,193,416 bags of Lactated Ringer's Injection because potential punctures may compromise sterility and cause leaks.

    Product
    Lactated Ringer's Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7953-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0279-2015·2014-12-03

    Hospira Recalls 5% Dextrose Injection Bags Due to Sterility Concerns

    Hospira is recalling 301,560 bags of 5% Dextrose Injection due to potential punctures that may compromise sterility and cause leaks.

    Product
    5% Dextrose Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7922-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0278-2015·2014-12-03

    Hospira Recalls Potassium Chloride IV Bags Due to Sterility Concerns

    Hospira is recalling 836,460 bags of Potassium Chloride IV solution due to potential punctures that may compromise sterility and cause leaks.

    Product
    Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7902-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0259-2015·2014-12-03

    Perry Drug Recalls Compounded Testosterone Syringes Due to Sterility Concerns

    Perry Drug Inc. is recalling compounded Testosterone CYP-250/PROP-20 mg syringes in Kansas and Missouri due to quality control issues affecting sterility assurance.

    Product
    Testosterone CYP-250/PROP-20 mg, 10 Ml Syringe, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0326-44
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0206-2015·2014-12-03

    Philips Medical Systems Recalls Gel-E and Squishon Baby Support Products Due to Mold

    Philips Medical Systems is recalling Gel-E Donut and Squishon 2 baby support products because mold was found on the gel-filled items.

    Product
    Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 91033-2. The products are intended to support and cradle a baby's head and/or body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0564-2015·2014-12-03

    MaraNatha Peanut Butter Recalled for Potential Salmonella Contamination

    nSpired Natural Foods is recalling MaraNatha No Stir Creamy Peanut Butter due to potential Salmonella contamination. The product was distributed in the US, Canada, and other countries.

    Product
    MaraNatha No Stir Creamy Peanut Butter, 16 oz., UPC 51651092210; MaraNatha No Stir Creamy Peanut Butter, 500 gram, UPC 51651093408.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0589-2015·2014-12-03

    Marathon Ventures Recalls Macadamia Nuts Due to Salmonella Florida Contamination

    Marathon Ventures Inc. is recalling various brands of macadamia nuts nationwide due to possible contamination with Salmonella florida.

    Product
    Macadamia nuts in various formats: (1.) Western Family Macadamia Diced Nuts, Net Wt 5 oz. plastic bags Distributed by:Western Family Foods, Inc. Portland, OR UPC 0 15400 16635 5 (2.) Shur Fine Macadamia Diced Nuts, Net Wt 5 oz. plastic bags. Distributed by:Western Family…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0260-2015·2014-12-03

    Perry Drug Recalls Methyl B12 Syringes Due to Sterility Concerns

    Perry Drug Inc. is recalling 186 prefilled syringes of Methyl B12 injection due to potential sterility assurance issues identified during an FDA inspection.

    Product
    Methyl B12 25 mg/mL Inj., 10 Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-2014-37
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0272-2015·2014-12-03

    Perry Drug Recalls HCG Vials Due to Sterility Assurance Concerns

    Perry Drug Inc. is recalling HCG-20,000 U/2 mL vials in Kansas and Missouri due to quality control issues affecting sterility assurance.

    Product
    HCG-20,000 U/2 mL Vial, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-2195-47
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0262-2015·2014-12-03

    Perry Drug Recalls Leuprolide Micro Lupron Kits Due to Sterility Concerns

    Perry Drug Inc. is recalling Leuprolide 50 mcg/0.1 mL Micro Lupron Kits in Kansas and Missouri due to potential sterility assurance risks identified during an FDA inspection.

    Product
    Leuprolide 50 mcg/0.1 mL Micro Lupron Kit, 5Ml, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-1124-57
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-0551-2015·2014-12-03

    Almond Butter Recalled for Potential Salmonella Contamination

    nSpired Natural Foods is recalling specific almond butter products due to potential Salmonella contamination. Consumers should stop using and return the products.

    Product
    MaraNatha Organic Roasted Creamy Almond Butter, 16 oz., UPC 51651060219; Whole Foods 365 Organic Creamy Almond Butter, 16 oz., UPC 99482405960.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0264-2015·2014-12-03

    Perry Drug Recalls Testosterone Cyp Syringes Due to Sterility Concerns

    Perry Drug Inc. is recalling Testosterone Cyp 200 mg/mL syringes due to quality control issues affecting sterility assurance.

    Product
    Testosterone Cyp 200 mg/mL Sesame Inj., 4Ml Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-7906-71
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0226-2015·2014-12-03

    Synthes Recalls Titanium Polyaxial Reduction Heads for Spine Screws

    Synthes (USA) Products LLC is recalling 24 Titanium Polyaxial Reduction Heads for Matrix Spine Screws because the inner diameter may not have been machined to the correct specification.

    Product
    Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine System. Intended for posterior pedicle screw fixation (Tl OS2- ilium), posterior hook fixation (Tl-L5), or anterolateral fixation…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0280-2015·2014-12-03

    Hospira Recalls IV Bags Due to Potential Sterility Breach

    Hospira is recalling 823,296 bags of 5% Dextrose and 0.45% Sodium Chloride Injection due to potential punctures that may compromise sterility.

    Product
    5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0274-2015·2014-12-03

    Perry Drug Recalls Compounded HCG Injections Due to Sterility Concerns

    Perry Drug Inc. is recalling compounded HCG injections in Kansas and Missouri due to potential sterility assurance issues identified during an FDA inspection.

    Product
    HCG - 10,000 Unit PF Inject, 1mL Syringe, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS NDC 88888-0216-49
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0265-2015·2014-12-03

    Perry Drug Recalls HCG Vials Due to Sterility Assurance Concerns

    Perry Drug Inc. is recalling HCG Low Dose vials in Kansas and Missouri due to quality control issues affecting sterility assurance.

    Product
    HCG Low Dose 30 IU/0.1 mL, 5 Ml vial, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0231-54
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0277-2015·2014-12-03

    Hospira Recalls Normosol-R IV Bags Due to Sterility Concerns

    Hospira is recalling 152,172 bags of Normosol-R IV solution due to potential punctures that may compromise sterility and cause leaks.

    Product
    Normosol-R pH 7.4 Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7670-09.
    Category
    Drug
    Distribution
    Distributed nationwide