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.

25276–25300 of 32194

  • SevereFDA (Drugs)·D-1453-2014·2014-07-30

    Trinity Care Solutions Recalls Levofloxacin Due to Sterility Concerns

    Trinity Care Solutions is recalling 7 units of compounded Levofloxacin 750 mg/250 mL D5W in Florida due to quality control concerns regarding sterility assurance.

    Product
    Levofloxacin 750 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx #29184, Discard After 05/28/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1462-2014·2014-07-30

    Trinity Care Solutions Recalls Nafcillin Due to Sterility Concerns

    Trinity Care Solutions is recalling Nafcillin 12 gm/300 mL units due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    Nafcillin 12 gm/300 mL, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29162, Discard After 05/21/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1473-2014·2014-07-30

    Trinity Care Solutions Recalls Vancomycin Due to Sterility Concerns

    Trinity Care Solutions is recalling 14 units of Vancomycin 1.25 gm/250 mL due to lack of assurance of sterility identified during an FDA inspection.

    Product
    Vancomycin 1.25 gm/250 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29140, Discard After 05/23/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1480-2014·2014-07-30

    Trinity Care Solutions Recalls Ceftriaxone Due to Sterility Concerns

    Trinity Care Solutions is recalling 5 units of Ceftriaxone 2 gm/100 mL D5W due to quality control concerns identified during an FDA inspection.

    Product
    Ceftriaxone 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29150, Discard After 05/17/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-2225-2014·2014-07-30

    PRAN Turmeric Spice Powder Recalled for Lead Contamination

    Asia Cash & Carry Inc. is recalling PRAN brand Turmeric Spice Powder because testing found 28 ppm of lead.

    Product
    PRAN brand Spice Powder TURMERIC, Net Wt. 8.82 oz./250g, UPC 8 31730 00551 --- PRODUCT OF BANGLADESH -- Manufactured by/Fabricado por: PRAN AGRO LTD, PRAN-RFL Center, 105 Middle Badda, Dhaka-1212, Bangladesh --- This product is packed in a clear plastic jar with a yellow…
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-1459-2014·2014-07-30

    Trinity Care Solutions Recalls Compounded Cubicin Due to Sterility Concerns

    Trinity Care Solutions is recalling 7 units of compounded Cubicin in Florida due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    Cubicin 486 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, RX # 29038, Discard After 05/20/2014
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1479-2014·2014-07-30

    Trinity Care Solutions Recalls Cefepime Due to Sterility Concerns

    Trinity Care Solutions is recalling Cefepime 1 gm/100 mL 0.9%NS due to lack of assurance of sterility identified during an FDA inspection.

    Product
    Cefepime 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29011, Discard After 05/21/14, Rx # 29141, Discard After 05/22/14, Rx # 29171, Discard After 05/20/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1474-2014·2014-07-30

    Trinity Care Solutions Recalls Vancomycin Due to Sterility Concerns

    Trinity Care Solutions is recalling 16 units of Vancomycin 750 mg/150mL D5W due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    Vancomycin 750 mg/150mL D5W,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28878, Discard After 05/16/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1449-2014·2014-07-30

    Shamrock Medical Recalls Mislabelled Pramipexole Tablets Packaged as Nebivolol

    Shamrock Medical Solutions is recalling Pramipexole Dihydrochloride tablets that were incorrectly labeled as Nebivolol. The error poses a risk of patients receiving the wrong medication.

    Product
    Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx, packaged and labeled to contain Nebivolol tablets, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Northstar Rx, Memphis, TN NDC 16714-586-01
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-1454-2014·2014-07-30

    Trinity Care Solutions Recalls Vancomycin Due to Sterility Concerns

    Trinity Care Solutions is recalling 22 units of Vancomycin 750 mg/100 mL in Florida due to quality control concerns regarding sterility assurance.

    Product
    Vancomycin 750 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28289, Discard After 02/5/14; Rx # 29189, Discard After 05/23/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2021-2014·2014-07-30

    Blood Glucose Test Strips Recalled for Inappropriate Labeling and Marketing

    Diabetic Supply of Suncoast, Inc. is recalling Advocate Redi-Code+ blood glucose test strips because they were inappropriately labeled and marketed.

    Product
    ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: The ADVOCATE¿ Redi-Code+ BMB-BA006A Blood Glucose test strips are used only with the ADVOCATE¿ Redi-Code+ BMB-EA004S meter to quantitatively measure glucose in fresh capillary whole blood samples drawn…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1455-2014·2014-07-30

    Trinity Care Solutions Recalls Pfizerpen Due to Sterility Concerns

    Trinity Care Solutions is recalling 7 units of Pfizerpen (penicillin G) compounded in Florida due to quality control concerns regarding sterility assurance.

    Product
    Pfizerpen (penicillin G) 24 MU/300 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29183, Discard After 05/21/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1469-2014·2014-07-30

    Trinity Care Solutions Recalls Ambisome Due to Sterility Concerns

    Trinity Care Solutions is recalling Ambisome 285 mg/250 mL D5W in Florida due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    Ambisome 285 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28300, Discard After 02/7/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1482-2014·2014-07-30

    Trinity Care Solutions Recalls Ceftriaxone Due to Sterility Concerns

    Trinity Care Solutions is recalling 12 units of Ceftriaxone 1 gm/50 mL D5W in Florida due to quality control concerns identified during an FDA inspection.

    Product
    Ceftriaxone 1 gm/50 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29190, Discard After 05/23/14, Rx # 29068, Exp 05/18/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-2206-2014·2014-07-30

    Flowers Foods Recalls BBQ Pull-A-Part Bread for Undeclared Milk Allergen

    Flowers Foods is recalling specific brands of BBQ Pull-A-Part Bread because products made with margarine failed to declare milk as an ingredient.

    Product
    BBQ Pull-A-Part Bread (Brands: Sunbeam (UPC 0 77633 05303 1), Bunny (UPC 0 71025 01500 3), Flowers [Foodservice] (UPC 0 72250 01866 1) and Ingles (UPC 0 86854 01543 8), 16oz clear flexible plastic bags, Distributed by Flowers Bakeries, LLC, Thomasville, GA 31757.
    Category
    Food
    Distribution
    4 states
  • SevereNHTSA·14V464000·2014-07-30

    Suzuki Recalls 2010-2013 Kizashi Vehicles for Fuel Tank Fire Risk

    Suzuki is recalling 2010-2013 Kizashi vehicles because spider webs may block a fuel system hose, causing a fuel leak and increasing the risk of a fire.

    Product
    SUZUKI — SUZUKI KIZASHI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1448-2014·2014-07-30

    Shamrock Recalls Metformin ER Tablets Labeled as Immediate Release

    Shamrock Medical Solutions is recalling metformin ER tablets that were incorrectly labeled as immediate release. The mislabeling could lead to incorrect dosing.

    Product
    metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate Release (IR), Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Amneal/Interpharm, Hauppauge, NY NDC 53746-178-01
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Food)·F-2223-2014·2014-07-30

    Fahman Enterprises Recalls Pran Spice Powder Turmeric Due to Lead Levels

    Fahman Enterprises, Inc. is recalling 4 cases of Pran Spice Powder Turmeric due to elevated levels of lead. The product was distributed in the Dallas, Texas area.

    Product
    Pran Spice Powder Turmeric , 14.10 oz. (400g) clear plastic laminated pouch, UPC 8 3173000502 3
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1460-2014·2014-07-30

    Trinity Care Solutions Recalls Invanz Due to Sterility Concerns

    Trinity Care Solutions is recalling 12 units of compounded Invanz in Florida due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    Invanz (ertapenem)1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29157, Discard After 05/19/14; Rx # 29097, Discard After 05/20/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1466-2014·2014-07-30

    Trinity Care Solutions Recalls Cefazolin Due to Sterility Concerns

    Trinity Care Solutions is recalling 21 units of Cefazolin 1 gm/100 mL 0.9%NS in Florida due to quality control concerns regarding sterility assurance.

    Product
    Cefazolin 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28837, Discard After 04/11/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1456-2014·2014-07-30

    Trinity Care Solutions Recalls Desferal Sterile Compounds Due to Sterility Concerns

    Trinity Care Solutions is recalling Desferal sterile compounds due to quality control concerns identified during an FDA inspection.

    Product
    Desferal 2.5 gm/14 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, Rx # 28314, Discard After 05/22/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1475-2014·2014-07-30

    Trinity Care Solutions Recalls Vancomycin Due to Sterility Concerns

    Trinity Care Solutions is recalling 14 units of Vancomycin 1.25 gm/100 mL 0.9%NS in Florida due to lack of assurance of sterility identified during an FDA inspection.

    Product
    Vancomycin 1.25 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29185, Discard After 05/23/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1481-2014·2014-07-30

    Trinity Care Solutions Recalls Cefepime Due to Sterility Concerns

    Trinity Care Solutions is recalling 11 units of Cefepime 2 gm/100 mL 0.9%NS due to quality control concerns identified during an FDA inspection.

    Product
    Cefepime 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28879, Discard After 05/21/14
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·14E051000·2014-07-29

    Cummins Fleetguard Fuel Filter Recall for Engine Stalling Risk

    Cummins is recalling specific Fleetguard UFF-XT fuel filters installed on ISB and ISL engines because the filter shell may separate, causing the engine to stall without warning and increasing crash risk.

    Product
    FUEL SYSTEM, DIESEL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide