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.

27951–27975 of 32242

  • SevereFDA (Drugs)·D-644-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls HCG Syringes Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling HCG 2000 units/ml syringes because FDA inspection findings raised concerns about quality control and assurance of sterility.

    Product
    HCG 2000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-637-2013·2013-07-10

    Cyclosporine 2% Ophthalmic Recalled Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling Cyclosporine 2% ophthalmic due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Cyclosporine 2% ophthalmic, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1661-2013·2013-07-10

    DJO VenaFlow Elite Compression Pump Recalled for Battery Fire Risk

    DJO, LLC is recalling VenaFlow Elite 30B-B and 30BI-B compression pumps due to a potential battery leakage issue that could cause a fire.

    Product
    VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V305000·2013-07-10

    Keystone Laredo Fifth Wheel Recall for Battery Box Support Defect

    Keystone RV is recalling 2013-2014 Laredo Fifth Wheel vehicles because the battery box may fall out of position, creating a fire or road hazard.

    Product
    KEYSTONE — KEYSTONE LAREDO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-655-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Methylcobalamin Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling specific lots of Methylcobalamin 12.5 mg/ml because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Methylcobalamin 12.5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Food)·F-1587-2013·2013-07-10

    Hannaford Oatmeal Raisin Cookies Recalled for Undeclared Tree Nuts

    Delhaize America is recalling Hannaford Gourmet Oatmeal Raisin Cookies because they may contain undeclared tree nuts. The product was sold in five northeastern states.

    Product
    Hannaford Gourmet Oatmeal Raisin Cookies (9 oz. package) UPC # 0004126872715
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-675-2013·2013-07-10

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

    Clinical Specialties Compounding Pharmacy is recalling specific lots of 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-636-2013·2013-07-10

    Cyclosporine 1% Ophthalmic Drops Recalled for Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling specific lots of Cyclosporine 1% ophthalmic drops due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Cyclosporine 1% ophthalmic drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1656-2013·2013-07-10

    HealthLink Recalls Biopsy Punches Due to Lack of Sterilization

    Clorox Healthcare Holdings is recalling 772,600 units of Argent Surgical Systems Biopsy Punches because they were not sterilized.

    Product
    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-657-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Mitomycin Solution Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling specific lots of Mitomycin (modified) 0.02% solution because FDA inspection findings raised concerns about quality control processes and assurance of sterility.

    Product
    Mitomycin (modified) 0.02% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-626-2013·2013-07-10

    Baxter Recalls Heparin Sodium Injection Due to Sterility Concerns

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

    Product
    HEPARIN SODIUM IN SODIUM CHLORIDE — HEPARIN SODIUM IN SODIUM CHLORIDE (HEPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-654-2013·2013-07-10

    Methylcobalamin Injection Recalled for Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling Methylcobalamin 1250 mcg/ml injections due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Methylcobalamin 1250 mcg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-669-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Test Cyp 250 mg-lidocaine 5 mg/ml

    Clinical Specialties Compounding Pharmacy is recalling Test Cyp 250 mg-lidocaine 5 mg/ml due to lack of assurance of sterility identified during an FDA inspection.

    Product
    Test Cyp 250 mg-lidocaine 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-645-2013·2013-07-10

    FDA Recalls HCG Syringes Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling HCG 500 units/ml syringes distributed in Florida, Georgia, and South Carolina due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    HCG 500 units/ml, 10 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-660-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Pap 300 mg-phent 10 mg-prost 100 mcg

    Clinical Specialties Compounding Pharmacy is recalling specific lots of Pap 300 mg-phent 10 mg-prost 100 mcg due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Pap 300 mg-phent 10 mg-prost 100 mcg, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-656-2013·2013-07-10

    Mitomycin 0.04% Solution Recalled Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling specific lots of Mitomycin 0.04% solution due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Mitomycin 0.04% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-662-2013·2013-07-10

    Progesterone Injection Recalled Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling specific lots of Progesterone 50 mg/ml because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Progesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-640-2013·2013-07-10

    Estradiol Valerate Injection Recalled Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling Estradiol Valerate 20 mg/ml injections due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Estradiol Valerate 20 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-663-2013·2013-07-10

    Sodium Chloride Recall Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling Sodium Chloride (23.4%) due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Sodium Chloride (23.4%), Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states