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.

21051–21075 of 32121

  • SevereFDA (Drugs)·D-0402-2016·2015-12-09

    Western Drug Recalls Dep-Estradiol Injection Due to Sterility Concerns

    Western Drug is recalling Dep-Estradiol 10 mg/mL Injection because the company cannot ensure the product is sterile. The recall covers 9 containers distributed nationwide.

    Product
    Dep-Estradiol 10 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0453-2016·2015-12-09

    Western Drug Recalls Squaric Acid 4% Injection Due to Sterility Concerns

    Western Drug is recalling Squaric Acid 4% Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.

    Product
    Squaric Acid 4% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0483-2016·2015-12-09

    Western Drug Recalls Quad Mix Strong Injections Due to Sterility Concerns

    Western Drug is recalling all lots of Quad Mix Strong Injections because the company cannot ensure the product is sterile. The recall covers distribution in eight US states.

    Product
    Quad Mix Strong Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0405-2016·2015-12-09

    Western Drug Recalls Furosemide Solution Due to Sterility Concerns

    Western Drug is recalling Furosemide 20 mg/mL solution because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.

    Product
    Furosemide 20 mg/mL svn Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0471-2016·2015-12-09

    Western Drug Recalls Hydroxocobalamin Injections Due to Sterility Concerns

    Western Drug is recalling Hydroxocobalamin 1mg Injections because the company cannot guarantee the product is sterile.

    Product
    Hydroxocobalamin 1mg Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0481-2016·2015-12-09

    Western Drug Recalls Triamcinolone and Lidocaine Injection Due to Sterility Concerns

    Western Drug is recalling 16 containers of Triamcin40/Lido5 mg/mL Sus due to a lack of assurance of sterility. The product was distributed nationwide in eight states.

    Product
    Triamcin40/Lido5 mg/mL Sus, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0351-2016·2015-12-09

    Philips Allura Xper Cardio Systems Recalled for Ceiling Suspension Fall Risk

    Philips Medical Systems is recalling 16 Allura Xper cardio systems because the monitor ceiling suspension system may fall.

    Product
    Philips Healthcare Xper cardio systems Model : 722123 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0404-2016·2015-12-09

    Western Drug Recalls Folic Acid Injection Due to Sterility Concerns

    Western Drug is recalling Folic Acid Injection due to a lack of assurance of sterility. The product was distributed nationwide in eight states.

    Product
    Folic Acid Injection 5 mg/mL,10 mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0447-2016·2015-12-09

    Western Drug Recalls PZI 40 Insulin Due to Sterility Concerns

    Western Drug is recalling 9 containers of PZI 40 Insulin (Human) because the product lacks assurance of sterility.

    Product
    PZI 40 Insulin (Human) Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0440-2016·2015-12-09

    Western Drug Recalls 18 Containers of Omnitrope Injection Kits

    Western Drug is recalling 18 containers of Omnitrope 17.4U/10mL Injection Kits due to a lack of assurance of sterility. The product was distributed nationwide in eight states.

    Product
    Omnitrope 17.4U/10mL Inj-Kit, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V826000·2015-12-09

    Jeep Cherokee Recall: Power Liftgate Module Fire Risk

    Chrysler is recalling 2015-2016 Jeep Cherokees with power liftgates because water leaks into the control module, creating a fire risk.

    Product
    JEEP — JEEP CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0464-2016·2015-12-09

    Western Drug Recalls Tri-Mix ED Injection Due to Sterility Concerns

    Western Drug is recalling 68 containers of Tri-Mix ED Injection because the product lacks assurance of sterility. The recall covers distribution in eight U.S. states.

    Product
    Tri-Mix ED Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0505-2016·2015-12-09

    Methyfolate Capsules Recalled for Potential Penicillin Cross Contamination

    Life Science Pharmacy Inc. is recalling Methyfolate Capsules due to potential penicillin cross contamination. The recall is nationwide and affects all lots.

    Product
    METHYLFOLATE Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0506-2016·2015-12-09

    Methyfolate Injection Recalled for Potential Penicillin Contamination

    Life Science Pharmacy Inc. is recalling Methyfolate Injection due to potential penicillin cross-contamination. The recall covers all lots distributed nationwide.

    Product
    METHYLFOLATE Injection, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0474-2016·2015-12-09

    Western Drug Recalls Sodium Hydroxide 10% Injection Due to Sterility Concerns

    Western Drug is recalling Sodium Hydroxide 10% Injection because the company cannot ensure the product is sterile. The recall covers all lots distributed nationwide.

    Product
    Sodium Hydroxide 10% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0354-2016·2015-12-09

    Philips Xper Vascular System Monitor Ceiling Suspension Recall

    Philips Medical Systems is recalling 22 Allura Xper vascular systems because the monitor ceiling suspension system may fall.

    Product
    Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0460-2016·2015-12-09

    Western Drug Recalls Tev-Tropin Injection Due to Sterility Concerns

    Western Drug is recalling six containers of Tev-Tropin (Somatropin) Injection due to a lack of assurance of sterility. The product was distributed nationwide in eight states.

    Product
    Tev-Tropin (Somatropin) Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0488-2016·2015-12-09

    Life Science Pharmacy Recalls Hydroxocobalamin Injection Due to Penicillin Contamination

    Life Science Pharmacy Inc. is recalling Hydroxocobalamin Injection due to potential penicillin cross-contamination. The recall covers all lot numbers and expiration dates distributed nationwide.

    Product
    HYDROXOCOBALAMIN Injection, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0507-2016·2015-12-09

    Life Science Pharmacy Recalls HCG Injections Due to Penicillin Contamination

    Life Science Pharmacy Inc. is recalling Human Chorionic Gonadotropin (HCG) injections nationwide due to potential penicillin cross-contamination.

    Product
    HUMAN CHORIONIC GONADOTROPIC (HCG) Injection, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0330-2016·2015-12-09

    World Variety Recalls Italian Pine Nuts Due to Salmonella Risk

    World Variety Produce Inc. is recalling specific lots of Melissa's Italian Pine Nuts because they may be contaminated with Salmonella.

    Product
    Melissa's Italian Pine Nuts, 2oz (57g), 12 cartons/case, UPC 0 45255 14351 5 Melissa's Profit Strip Pine Nuts Italy, 2oz (57g), 12 cartons/case, UPC 0 45255 14351 5.
    Category
    Food
    Distribution
    23 states
  • SevereFDA (Drugs)·D-0442-2016·2015-12-09

    Western Drug Recalls Podophyllum 40% Topical Due to Sterility Concerns

    Western Drug is recalling Podophyllum 40% Topical because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.

    Product
    Podophyllum 40% Topical, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0439-2016·2015-12-09

    Western Drug Recalls Novarel HCG Vials Due to Sterility Concerns

    Western Drug is recalling Novarel HCG 10000U/Vial prescription vials nationwide due to a lack of assurance of sterility.

    Product
    Novarel "HCG" 10000U/Vial, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V829000·2015-12-09

    Newmar Recalls Motorhomes Due to Steering Gear Bracket Crack Risk

    Newmar is recalling specific model year 1997-2005 motorhomes because a steering gear mounting bracket may crack, potentially causing a loss of steering ability.

    Product
    NEWMAR — NEWMAR KOUNTRY AIRE, LONDON AIRE, MOUNTAIN AIRE, DUTCH STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide