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.

21101–21125 of 32121

  • SevereFDA (Drugs)·D-0451-2016·2015-12-09

    Western Drug Recalls Serum Tears 20% Opth Due to Sterility Concerns

    Western Drug is recalling Serum Tears 20% Opth eye drops because the product may not be sterile. The recall covers three containers distributed nationwide.

    Product
    Serum Tears 20% Opth, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0399-2016·2015-12-09

    Western Drug Boric Acid Ear Drops Recalled for Sterility Concerns

    Western Drug is recalling Boric Acid 1% Ear Drops due to a lack of assurance of sterility. The product was distributed nationwide in eight states.

    Product
    Boric Acid 1% Ear Drop, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0436-2016·2015-12-09

    Western Drug Recalls Magnesium Sulfate Injection Due to Sterility Concerns

    Western Drug is recalling Magnesium Sulfate 50% Injection because the company cannot ensure the product is sterile. The recall covers four containers distributed nationwide.

    Product
    Magnesium Sulfate 50% Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0397-2016·2015-12-09

    Western Drug Recalls B-12 and B6 Injection Due to Sterility Concerns

    Western Drug is recalling B-12 1000/B6 1000 mcg/mL Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.

    Product
    B-12 1000/B6 1000 mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0433-2016·2015-12-09

    Western Drug Recalls Ketorolac Injection Due to Sterility Concerns

    Western Drug Inc. is recalling Ketorolac 40mg/mL Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.

    Product
    Ketorolac 40mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0465-2016·2015-12-09

    Western Drug Recalls Tri-Test Injection Due to Sterility Concerns

    Western Drug is recalling 3 containers of Tri-Test 1:1:1 300mg/mL Injection because the product lacks assurance of sterility.

    Product
    Tri-Test 1:1:1 300mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0501-2016·2015-12-09

    Life Science Pharmacy Recalls TRI-EST Capsules Due to Penicillin Contamination

    Life Science Pharmacy Inc. is recalling TRI-EST Capsules because they may be contaminated with penicillin. The recall covers all lots distributed nationwide.

    Product
    TRI-EST Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0496-2016·2015-12-09

    Life Science Pharmacy Recalls BI-EST Capsules Due to Penicillin Contamination

    Life Science Pharmacy Inc. is recalling BI-EST Capsules because they may be contaminated with penicillin. The recall covers all lots distributed nationwide.

    Product
    BI-EST Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0396-2016·2015-12-09

    Western Drug Recalls AMP50/B121MG Injection Due to Sterility Concerns

    Western Drug is recalling AMP50/B121MG Complex Mix/ML Injection because the product lacks assurance of sterility. The recall covers four containers distributed nationwide.

    Product
    AMP50/B121MG Complex Mix/ML Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0416-2016·2015-12-09

    Western Drug Recalls Mupiro/Doxycyc Sinus Rinse Due to Sterility Concerns

    Western Drug is recalling Mupiro/Doxycyc Sinus Rinse because the product lacks assurance of sterility. The recall affects all lots distributed nationwide.

    Product
    Mupiro/Doxycyc Sinus Rinse, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0438-2016·2015-12-09

    Western Drug Recalls N.A.C. 20% Solution Due to Sterility Concerns

    Western Drug is recalling N.A.C. 20% SVN Sol due to a lack of assurance of sterility. The product was distributed nationwide in eight states.

    Product
    N.A.C. 20% SVN Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0431-2016·2015-12-09

    Western Drug Recalls Hydrochloric Acid Injection Due to Sterility Concerns

    Western Drug is recalling Hydrochloric Acid 2mg Injection because there is a lack of assurance of sterility. The product was distributed nationwide in eight states.

    Product
    Hydrochloric Acid 2mg Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0467-2016·2015-12-09

    Western Drug Recalls Vitamin B12 Injections Due to Sterility Concerns

    Western Drug is recalling Vitamin B12 injections because the company cannot ensure the product is sterile. The recall covers eight containers distributed nationwide.

    Product
    Vitamin B12 (Cyan) Inj 100mcg/mL, 1000mcg/mL, Rx Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0454-2016·2015-12-09

    Western Drug Recalls Super B Comp w/Cyano 3X Inj Due to Sterility Concerns

    Western Drug is recalling 15 containers of Super B Comp w/Cyano 3X Inj because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.

    Product
    Super B Comp w/Cyano 3X Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0300-2016·2015-12-09

    Golden Smell Hot Pot Meat Ball Medly Recalled for Undeclared Eggs

    Strong America Limited is recalling Golden Smell brand Hot Pot Meat Ball Medly because it contains undeclared eggs, posing a risk to individuals with egg allergies.

    Product
    GOLDEN SMELL brand Hot Pot Meat Ball Medly, NET WT:1 LB (454g), UPC 8 881028 964381, Product of China -- Distributor: Strong America Ltd., 2-39 4th Ave., Long Island City, NY 11101 --- Nutrition Facts information: Serving Size: 1 oz (28g), Servings Per Container: 16
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Drugs)·D-0482-2016·2015-12-09

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

    Western Drug is recalling Tri-Mix LOW ED Injection because there is a lack of assurance of sterility. The product was distributed nationwide in eight states.

    Product
    Tri-Mix LOW ED Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0425-2016·2015-12-09

    Western Drug Recalls Cyancobalamin Injections Due to Sterility Concerns

    Western Drug is recalling Cyancobalamin 2000mcg/mL injections because there is a lack of assurance of sterility. The product was distributed nationwide in eight states.

    Product
    Cyancobalamin 2000mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0428-2016·2015-12-09

    Western Drug Recalls HCG Injection Due to Sterility Assurance Concerns

    Western Drug is recalling HCG 10,000U/10mL Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.

    Product
    HCG 10,000U/10mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0497-2016·2015-12-09

    Life Science Pharmacy Recalls BI-EST Gels Due to Penicillin Contamination

    Life Science Pharmacy Inc. is recalling BI-EST Gels because they may be contaminated with penicillin. The recall covers all lots distributed nationwide.

    Product
    BI-EST Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0410-2016·2015-12-09

    Western Drug Recalls Hydroxocobalamin Injection Due to Sterility Concerns

    Western Drug is recalling Hydroxocobalamin 5000IU/mL Injection because the product lacks assurance of sterility. The recall covers two containers distributed nationwide.

    Product
    Hydroxocobalamin 5000IU/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0466-2016·2015-12-09

    Western Drug Recalls Verapamil Injection Due to Sterility Concerns

    Western Drug is recalling Verapamil 120mg/12mL Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.

    Product
    Verapamil 120mg/12mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0468-2016·2015-12-09

    Western Drug Recalls Vitamin B-Complex 100 Injection Due to Sterility Concerns

    Western Drug is recalling 7 containers of Vitamin B-Complex 100 Injection because there is a lack of assurance of sterility. The product was distributed nationwide in eight states.

    Product
    Vitamin B-Complex 100 Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0446-2016·2015-12-09

    Western Drug Recalls Pyridoxine B6 Injections Due to Sterility Concerns

    Western Drug is recalling Pyridoxine B6 100mg injections because the company cannot ensure the product is sterile. The recall covers three containers distributed nationwide.

    Product
    Pyridoxine B6 100mg Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide