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.

27851–27875 of 32242

  • SevereFDA (Drugs)·D-702-2013·2013-07-17

    Olympia Pharmacy Recalls Atropine Sulfate Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Atropine Sulfate 50 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Atropine Sulfate 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-746-2013·2013-07-17

    Olympia Pharmacy Recalls Ketoprofen Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Ketoprofen Solution 10% Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Ketoprofen Solution 10% Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-745-2013·2013-07-17

    Olympia Pharmacy Recalls Ketamine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Ketamine 100 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Ketamine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-715-2013·2013-07-17

    Cre-O-Pan Injection Recalled Due to Sterility Concerns

    Olympia Pharmacy is recalling Cre-O-Pan Injection because FDA inspection findings raised concerns about quality control processes and assurance of sterility.

    Product
    Cre-O-Pan Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-699-2013·2013-07-17

    Olympia Pharmacy Recalls Aminocaproic Acid Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Aminocaproic Acid 0.5mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Aminocaproic Acid 0.5mg/ml Injection,compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-761-2013·2013-07-17

    Olympia Pharmacy Recalls Miconazole Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Miconazole 3% Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Miconazole 3% Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-703-2013·2013-07-17

    Olympia Pharmacy Recalls Beta Alanine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Beta Alanine and L-Carnosine injections because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Beta Alanine 100 mg/ml / l-carnosine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-708-2013·2013-07-17

    Olympia Pharmacy Recalls Buprenorphine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Buprenorphine 0.3 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Buprenorphine 0.3 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1668-2013·2013-07-17

    Medtronic MiniMed Paradigm Insulin Infusion Sets Recalled for Malfunction Risk

    Medtronic MiniMed is recalling Paradigm insulin infusion sets because they may malfunction and deliver incorrect insulin volumes if exposed to fluids.

    Product
    Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-694-2013·2013-07-17

    Olympia Pharmacy Recalls Adenosine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Adenosine-Mono-Phosphate Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Adenosine-Mono-Phosphate Injection, 200 mg/ml, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-730-2013·2013-07-17

    Olympia Pharmacy Recalls Furosemide Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Furosemide 50 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Furosemide 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1596-2013·2013-07-17

    Food Source Recalls Tomorrow's Tropicals Mangos Sourced from Agricola Daniella

    Food Source, Inc. is voluntarily recalling Tomorrow's Tropicals Mangos sourced from Agricola Daniella following an FDA warning to consumers not to eat mangoes from that supplier.

    Product
    Tomorrow's Tropicals Mangos Distributed by FoodSource A C.H. Robinson Company Edinburg, Texas 78539
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-701-2013·2013-07-17

    Olympia Pharmacy Recalls Atipamezole Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Atipamezole 10 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Atipamezole 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-743-2013·2013-07-17

    Olympia Pharmacy Recalls Iodine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Iodine 20 mg Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Iodine 20 mg Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-742-2013·2013-07-17

    Olympia Pharmacy Recalls Idoxuridine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Idoxuridine 0.1% Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Idoxuridine 0.1% Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-734-2013·2013-07-17

    Olympia Pharmacy Recalls Gentamicin Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Gentamicin 80 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Gentamicin 80 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1667-2013·2013-07-17

    Bryan Medical Recalls Mislabeled Pediatric Tracheostomy Tubes

    Bryan Medical Inc is recalling 5 units of Tracoe Mini 3.0mm pediatric tracheostomy tubes because they were mislabeled as smaller infant tubes.

    Product
    Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-785-2013·2013-07-17

    Olympia Pharmacy Recalls Taurine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Taurine 100 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Taurine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-744-2013·2013-07-17

    Olympia Pharmacy Recalls ITPP and DMG Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling ITPP 50 mg/ml DMG 100 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    ITPP 50 mg/ml DMG 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1607-2013·2013-07-17

    Garden Highway Mango Medley Recalled for Potential Salmonella Contamination

    GHSW, LLC is recalling Garden Highway Mango Medley fruit cups due to potential Salmonella contamination from mangoes sourced from Agricola Daniella.

    Product
    Garden Highway Fresh Fruit No Preservatives Perishable Keep Refrigerated Mango Medley Net Wt. 10 oz (284g) Renaissance Food Group LLC, Rancho Cordova, CA 95670, UPC: 826766214334 www.gardenhighway.com Ingredients: Cantaloupe, Pineapple, Mango, Red Grapes Packed in its own…
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-714-2013·2013-07-17

    Olympia Pharmacy Recalls Clenbuterol Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Clenbuterol 0.03mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Clenbuterol 0.03mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-766-2013·2013-07-17

    Olympia Pharmacy Recalls PEN-DEX-CHLOR Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling PEN-DEX-CHLOR Injection because FDA inspection findings raised concerns about quality control processes and assurance of sterility.

    Product
    PEN-DEX-CHLOR Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-789-2013·2013-07-17

    Olympia Pharmacy Recalls Vitamin 15 Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Vitamin 15 (HEMO15) Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Vitamin 15 (HEMO15) Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide