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.

21151–21175 of 32121

  • SevereFDA (Food)·F-0328-2016·2015-12-09

    Custom Foods Recalls Founders Pride Chocolate Chip Cookies Due to Peanut Contamination

    Custom Foods Inc. is recalling Founders Pride Chocolate Chip Cookies because they may be contaminated with peanuts. The product was distributed to restaurants in seven states.

    Product
    Founders Pride Chocolate Chip Cookies 120 - 2.5 oz frozen dough pieces packaged per case, Net Wt. 18.75 lbs. (8.50 Kg.) The responsible name on the label is Custom Foods, Inc., DeSoto, KS 66018.
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0421-2016·2015-12-09

    Western Drug Recalls Calcium Chloride Injection Due to Sterility Concerns

    Western Drug is recalling Calcium Chloride Dihydrate Injection because there is a lack of assurance of sterility. The product was distributed nationwide in eight states.

    Product
    Calcium Chloride Dihydrate Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0434-2016·2015-12-09

    Western Drug Recalls Lidocaine Injection Due to Sterility Concerns

    Western Drug is recalling Lidocaine Injection 1% and 2% due to a lack of assurance of sterility. The product was distributed nationwide in eight states.

    Product
    Lidocaine Injection 1% , 2%, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0340-2016·2015-12-09

    Bauli Recalls Doria Amaretti Biscuits Due to High Aflatoxin B1 Levels

    Bauli S.p.A. is recalling Doria Amaretti Biscuits because of high levels of Aflatoxin B1. The recall affects 495 cartons distributed in New York.

    Product
    Doria AUTHENTIC ITALIAN GOODNESS, Amaretti BISCUITS, Net Wt. 8.81 oz (250g), UPC 799540801696, BAULI S.p.A Via Verdi, 31 37060 Castel d'Azzano (VR) Stabilimento di Via Pontebbana, 32 Orsago (Treviso) Italia. PRODUCT OF ITALY
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0500-2016·2015-12-09

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

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

    Product
    BI-EST Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0459-2016·2015-12-09

    Western Drug Recalls Testosterone Injections Due to Sterility Concerns

    Western Drug Inc. is recalling 39 containers of Testosterone Injection due to a lack of assurance of sterility. The products were distributed nationwide in eight states.

    Product
    Testosterone Injection 100mg/mL, 200mg/mL, 300mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0470-2016·2015-12-09

    Western Drug Recalls Wilson's Nasal Irrigation Solution Due to Sterility Concerns

    Western Drug is recalling Wilson's Nasal Irrigation Solution because the product lacks assurance of sterility. The recall affects two containers distributed nationwide.

    Product
    Wilson's Nasal Irrigation Solution, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0426-2016·2015-12-09

    Western Drug Recalls Dexpanthanol B5 Injection Due to Sterility Concerns

    Western Drug is recalling four containers of Dexpanthanol B5 250mg/mL Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.

    Product
    Dexpanthanol B5 250mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0423-2016·2015-12-09

    Western Drug Recalls Calcium Gluconate Injection Due to Sterility Concerns

    Western Drug is recalling Calcium Gluconate 10% Injection because the product lacks assurance of sterility. The recall covers two containers distributed nationwide.

    Product
    Calcium Gluconate 10% Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0478-2016·2015-12-09

    Western Drug Recalls Super B Complex Injections Due to Sterility Concerns

    Western Drug is recalling four containers of Super B Complex w/Cyano Inj due to a lack of assurance of sterility. The product was distributed nationwide in eight states.

    Product
    Super B Complex w/Cyano Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0417-2016·2015-12-09

    Western Drug Recalls Alcohol and Bupivicaine Solution Due to Sterility Concerns

    Western Drug is recalling Alcohol 4%/Bupivicaine 0.5% solution because there is a lack of assurance of sterility. The product was distributed nationwide in eight states.

    Product
    Alcohol4%/Bupivicaine0.5% sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0349-2016·2015-12-09

    Philips INTEGRIS Vascular System Recall for Ceiling Suspension Fall Risk

    Philips Medical Systems is recalling three INTEGRIS vascular systems because the monitor ceiling suspension system may fall.

    Product
    Philips Healthcare INTEGRIS vascular System Model : 722122 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-0437-2016·2015-12-09

    Western Drug Recalls Marcaine Injection Due to Sterility Concerns

    Western Drug Inc. is recalling 5 containers of Marcaine 0.24%/Ethanol 4% Injection because the product lacks assurance of sterility.

    Product
    Marcaine 0.24%/Ethanol 4% Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0502-2016·2015-12-09

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

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

    Product
    TRI-EST Lozenges, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0414-2016·2015-12-09

    Western Drug Recalls Methylcobalamin Injection Due to Sterility Concerns

    Western Drug is recalling 46 containers of Methylcobalamin Injection because there is a lack of assurance of sterility.

    Product
    Methylcobalamin Injection 1000 mcg/mL, 10000 mcg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereCPSC·16710·2015-12-08

    Kubota Recalls Utility Vehicles Due to Fire Hazard

    Kubota is recalling approximately 11,500 RTV-X1100C utility vehicles because combustible debris can contact the exhaust manifold and ignite, posing a fire hazard.

    Product
    Utility Vehicles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V823000·2015-12-08

    Audi Recalls A6 and A7 Vehicles Due to Passenger Air Bag Defect

    Volkswagen Group of America is recalling 2012-2013 Audi A6 and A7 vehicles because the passenger air bag system may fail to deploy in a crash.

    Product
    AUDI — AUDI A7, A6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V820000·2015-12-07

    Polaris Recalls 2015 GEM Electric Vehicles for Seat Belt Defect

    Polaris is recalling 2015 GEM electric vehicles because seat belt retractors may fail, preventing proper occupant restraint in a crash.

    Product
    GEM — GEM E6S, E4, ELXD, EL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V816000·2015-12-07

    Freightliner Cascadia CNG Vehicles Recalled for Exhaust Fire Risk

    Daimler Trucks North America is recalling 2013-2015 Freightliner Cascadia CNG vehicles because hot exhaust near the pressure relief device may cause gas release and fire.

    Product
    FREIGHTLINER — FREIGHTLINER CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V821000·2015-12-07

    Honda Recalls VFR1200F Motorcycles for Driveshaft Universal Joint Wear

    Honda is recalling 2010, 2012, and 2013 VFR1200F motorcycles because driveshaft universal joint bearings may wear prematurely, potentially causing the joint to separate or break.

    Product
    HONDA — HONDA VFR1200F
    Category
    Vehicle
    Distribution
    Distributed nationwide