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.

22326–22350 of 32168

  • SevereFDA (Drugs)·D-1382-2015·2015-09-02

    Liberty Drug Recalls Methylcobalamin Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling Methylcobalamin 5000 mcg/mL Injectable vials due to process deficiencies that could have compromised sterility.

    Product
    Methylcobalamin 5000 mcg/mL Injectable, 2 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1400-2015·2015-09-02

    Liberty Drug Recalls Papaverine Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling specific lots of Papaverine/Phentolamine/Atropine/PGE-1 Injectable due to process deficiencies that could compromise sterility.

    Product
    Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 75 mg/2.5 mg/0.1 mg/75 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1360-2015·2015-09-02

    Bactroban Ointment Recalled for Penicillin Contamination and Foreign Substances

    GlaxoSmithKline is recalling Bactroban Ointment due to penicillin cross-contamination and foreign substances found during manufacturing.

    Product
    Bactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. NDC 0029-1525-44
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1362-2015·2015-09-02

    GlaxoSmithKline Recalls Mupirocin Calcium Cream Due to Penicillin Contamination

    GlaxoSmithKline is recalling Mupirocin Calcium Cream, 2%, because the product was contaminated with penicillin and foreign substances during manufacturing.

    Product
    Mupirocin Calcium Cream, 2%, a) 15g tube (NDC 66993-942-15),b) 30g tube (NDC 66993-942-31), Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1355-2015·2015-09-02

    PharMEDium Recalls Heparin Sodium Injection Bags Due to Particulate Matter

    PharMEDium Services is recalling 480 bags of Heparin Sodium Injection USP due to the presence of particulate matter. The product was distributed nationwide.

    Product
    HEPARIN Sodium Injection USP, 12,500 USP Units added to 250 mL 5% Dextrose Injection USP (50 units per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K0418, NDC# 61553-418-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1387-2015·2015-09-02

    Liberty Drug Recalls Vancomycin Ophthalmic Solution Due to Sterility Concerns

    Liberty Drug & Surgical is recalling Vancomycin 25 mg/mL Ophthalmic Solution because process deficiencies may have compromised the product's sterility.

    Product
    Vancomycin 25 mg/mL Opthalmic Solution, packaged in a) 10 mL bottle and b) 15 mL bottle, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1385-2015·2015-09-02

    Liberty Drug Recalls Papaverine Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling Papaverine/Phentolamine/PGE-1 Injectable vials because process deficiencies may have compromised the product's sterility.

    Product
    Papaverine/Phentolamine/PGE-1 Injectable, 10 mg/0.6 mg/10 mcg/mL, 2.5 mL vials, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1383-2015·2015-09-02

    Liberty Drug Recalls Injectable Due to Sterility Process Deficiencies

    Liberty Drug & Surgical is recalling Papaverine/Phentolamine/Atropine/PGE-1 Injectable vials because process deficiencies may have compromised the product's sterility.

    Product
    Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 9 mg/1 mg/0.1 mg/10 mcg/mL, 2 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1389-2015·2015-09-02

    Liberty Drug Recalls Tobramycin Ophthalmic Solution Due to Sterility Concerns

    Liberty Drug & Surgical is recalling Tobramycin 14 mg/mL Ophthalmic Solution because process deficiencies may have compromised the product's sterility.

    Product
    Tobramycin 14 mg/mL Ophthalmic Solution, 15 mL bottle, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1353-2015·2015-09-02

    Pharmedium Recalls Oxytocin Injection Bags Due to Particulate Matter

    Pharmedium Services, LLC is recalling 72 bags of oxyTOCIN 15 Units in 5% Dextrose Injection due to the presence of particulate matter.

    Product
    oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP, packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K2677, NDC# 61553-777-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1401-2015·2015-09-02

    Liberty Drug Recalls Doxycycline IV Bags Due to Sterility Concerns

    Liberty Drug & Surgical is recalling 30 bags of Doxycycline/0.9% NaCl IV due to process deficiencies that could have compromised sterility.

    Product
    Doxycycline/0.9% NaCl 300 mg/500 mL IV, 500 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1402-2015·2015-09-02

    Liberty Drug Recalls Hydroxocobalamin Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling 6 vials of Hydroxocobalamin Injectable due to process deficiencies that could have compromised sterility.

    Product
    Hydroxocobalamin (Preserved) 1,000 mcg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1399-2015·2015-09-02

    Methadone Injection Recalled Due to Sterility Assurance Concerns

    Liberty Drug & Surgical is recalling Methadone 10 mg/mL Injection vials because process deficiencies could have compromised sterility.

    Product
    Methadone 10 mg/mL Injection, 10 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1388-2015·2015-09-02

    Liberty Drug Recalls Doxycycline IV Bags Due to Sterility Concerns

    Liberty Drug & Surgical is recalling 88 bags of Doxycycline IV solution because process deficiencies may have compromised sterility.

    Product
    Doxcycline/0.9% NaCl 150 mg/150 mL IV, 150 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereNHTSA·15V551000·2015-09-02

    Foretravel Recalls 2012-2014 Motorhomes Due to Loose Front Ball Joints

    Foretravel is recalling 2012-2014 Nimbus, Phenix, and IH45 motorhomes because loose front ball joints may separate, causing loss of steering control and increasing crash risk.

    Product
    FORETRAVEL — FORETRAVEL NIMBUS, IH45, PHENIX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1398-2015·2015-09-02

    Liberty Drug Recalls Phenol 6% Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling Phenol 6% Injectable vials because process deficiencies may have compromised the product's sterility.

    Product
    Phenol 6% Injectable, 30 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-3048-2015·2015-09-02

    Veggie Evolution Kale Crisps Recalled for Undeclared Soy

    It Takes A Village Foods is recalling Veggie Evolution Kale Crisps Zen Nori because the product contains soy, which is not declared on the label.

    Product
    Kale Crisps Zen Nori product is seaweed flavored dehydrated kale chip, sold under brand Veggie Evolution, each poly pouch has a net weight 1.5 oz. There are six packages per case. UPC is 7 13757 57480 8. The product's label is read in part: "***VEGGIE EVOLUTION***KALE…
    Category
    Food
    Distribution
    22 states
  • SevereFDA (Devices)·Z-2451-2015·2015-09-02

    Synthes Trauma Ex-Fix System Recalled for MR Labeling Corrections

    Synthes (USA) Products LLC is recalling the Trauma Ex-Fix System to correct MRI safety labeling. The recall identifies additional part numbers as MR Conditional and notes one serious injury.

    Product
    Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle; (M) for the construction of an external fixation frame for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1392-2015·2015-09-02

    Liberty Drug Recalls Hydroxocobalamin Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling 15 vials of Hydroxocobalamin Injectable due to process deficiencies that could have compromised sterility.

    Product
    Hydroxocobalamin (Preserved) 10,000 mcg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1396-2015·2015-09-02

    Morphine IV Bags Recalled Due to Sterility Assurance Concerns

    Liberty Drug & Surgical is recalling four bags of Morphine/0.9% NaCl IV solution because process deficiencies may have compromised sterility.

    Product
    Morphine/0.9 % NaCl 1 mg/mL IV, 250 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2462-2015·2015-09-02

    Arrow International Recalls PICC Kits with Potential Peel-Away Sheath Defect

    Arrow International is recalling 52,109 PICC kits because the peel-away sheath hub tabs may prematurely detach. One injury has been reported.

    Product
    PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1380-2015·2015-09-02

    Liberty Drug Recalls Cyanocobalamin Syringes Due to Sterility Concerns

    Liberty Drug & Surgical is recalling 6 syringes of Cyanocobalamin 500 mcg/mL Injectable due to process deficiencies that could have compromised sterility.

    Product
    Cyanocobalamin 500 mcg/mL Injectable, 1 mL pre-filled syringe, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1394-2015·2015-09-02

    Liberty Drug Recalls Doxycycline IV Bags Due to Sterility Concerns

    Liberty Drug & Surgical is recalling 112 bags of Doxycycline IV solution because process deficiencies may have compromised sterility.

    Product
    Doxycycline/0.9% NaCl 150 mg/250 mL IV, 250 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1404-2015·2015-09-02

    Liberty Drug Recalls Methylcobalamin Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling 6 vials of Methylcobalamin 1,000 mcg/mL Injectable due to process deficiencies that could have compromised sterility.

    Product
    Methylcobalamin 1,000 mcg/mL Injectable, 1.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states