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.

27976–28000 of 32242

  • SevereFDA (Food)·F-1589-2013·2013-07-10

    General Mills Recalls Cinnamon Toast Crunch Bowls Due to Salmonella Risk

    General Mills is recalling specific single-serve Cinnamon Toast Crunch bowls sold in foodservice establishments because an ingredient may contain salmonella.

    Product
    General Mills, Cinnamon Toast Crunch, 25% Less Sugar, Self-Serve Bowl, Net WT 1.0 oz ( 28g), Distributed by General Mills Sales, Minneapolis, MN 55440, Package UPC 00016000294448. Case: General Mills, BOWLPAK, Cinnamon Toast Crunch, Reduced Sugar, 96 - 1 oz (28g)…
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-661-2013·2013-07-10

    Phenylephrine-cyclopentolate recalled due to lack of assurance of sterility

    Clinical Specialties Compounding Pharmacy is recalling Phenylephrine-cyclopentolate due to FDA inspection findings regarding quality control and sterility.

    Product
    Phenylephrine-cyclopentolate, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Food)·F-1586-2013·2013-07-10

    Butterfly Bakery Harvest Berry Muffins Recalled for Undeclared Walnuts

    Butterfly Bakery Inc. is recalling Harvest Berry Muffins because they may contain undeclared walnuts, a major food allergen.

    Product
    Butterfly Bakery Harvest Berry Muffins (four muffins per package) Net. Wt. 14.5 OZ (410 g) UPC 6 43482 60014 8 Manufactured by: Butterfly Bakery Inc.200 Clifton Boulevard, Clifton, NJ 07013 T: 973.815.1501 Packaged in a plastic clam shell.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-680-2013·2013-07-10

    Vancomycin Recall Due to Sterility Concerns at Compounding Pharmacy

    Clinical Specialties Compounding Pharmacy is recalling Vancomycin 50 mg/ml due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Vancomycin 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-642-2013·2013-07-10

    Gentamicin Buffered Recall Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling Gentamicin buffered 36.4 mg/ml due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Gentamicin buffered 36.4 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-674-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Test Cyp 50 mg-estradiol cyp 2 mg/ml

    Clinical Specialties Compounding Pharmacy is recalling Test Cyp 50 mg-estradiol cyp 2 mg/ml due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Test Cyp 50 mg-estradiol cyp 2 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-628-2013·2013-07-10

    Baxter Recalls Sodium Chloride Injection Due to Sterility Concerns

    Baxter Healthcare is recalling specific lots of Sodium Chloride Injection due to a manufacturing defect that may compromise sterility.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-666-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Test Cyp 200 mg/ml Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling Test Cyp 200 mg/ml because FDA inspections raised concerns about quality control and sterility assurance. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    Test Cyp 200 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-632-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Acetylcysteine 10% Solution

    Clinical Specialties Compounding Pharmacy is recalling Acetylcysteine 10% Solution due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Acetylcysteine 10 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-679-2013·2013-07-10

    Tetracaine Solution Recalled for Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling Tetracaine 0.25% solution due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Tetracaine(buffered) 0.25% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1647-2013·2013-07-10

    Ortho-Clinical Diagnostics Recalls VITROS 5,1 FS Chemistry Systems Due to Electrical Short

    Ortho-Clinical Diagnostics is recalling 101 VITROS 5,1 FS Chemistry Systems because an electrical short can cause heat accumulation and melted wiring.

    Product
    1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS Chemistry System Refurbished (product code 6801890) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-658-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Ophthalmic Dilation Gel

    Clinical Specialties Compounding Pharmacy is recalling ophthalmic dilation gel due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Ophthalmic dilation gel, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereNHTSA·13V307000·2013-07-10

    Honda Recalls 2014 CTX700 Motorcycles for ABS Malfunction Risk

    Honda is recalling 2014 CTX700 motorcycles because a manufacturing error may cause the Anti-Lock Brake System to malfunction, increasing the risk of a crash.

    Product
    HONDA — HONDA CTX700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1663-2013·2013-07-10

    Siemens Linear Accelerator Recall Due to Potential Patient Mistreatment

    Siemens is recalling specific linear accelerator systems because a difficult-to-interpret calibration issue may have resulted in the mistreatment of cancer patients.

    Product
    Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Systems with BEAMVIEW capability. The intended use of the SIEMENS branded MEVATRON", ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is to deliver X-ray photon and electron…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-677-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Test Cyp 50 mg-estradiol Blend

    Clinical Specialties Compounding Pharmacy is recalling Test Cyp 50 mg-estradiol blend 22 mg due to lack of assurance of sterility.

    Product
    Test Cyp 50 mg-estradiol blend 22 mg, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-643-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls HCG Syringes Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling HCG 1000 units/ml syringes due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    HCG 1000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-668-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Testosterone and Estradiol Injection

    Clinical Specialties Compounding Pharmacy is recalling a specific lot of Test cyp 25 mg-Estradiol cyp 5 mg/ml injection due to lack of assurance of sterility.

    Product
    Test cyp 25 mg-Estradiol cyp 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-633-2013·2013-07-10

    Acetylcysteine 20% Solution Recalled Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling Acetylcysteine 20% solution due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Acetylcysteine 20 % solution, 100 ml bottle, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-639-2013·2013-07-10

    Estradiol Cypionate Injection Recalled Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling Estradiol Cypionate 5 mg/ml injections due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Estradiol Cypionate 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1620-2013·2013-07-10

    Zimmer Recalls Fukuda Retractors Due to Fractures During Surgery

    Zimmer, Inc. is recalling Fukuda retractors because they fracture at the grooves during use. The recall includes 722 units distributed worldwide.

    Product
    Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
    Category
    Medical Device
    Distribution
    Distributed nationwide