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.

27901–27925 of 32242

  • SevereFDA (Drugs)·D-784-2013·2013-07-17

    Tacrolimus eye drops recalled due to sterility concerns

    Olympia Pharmacy is recalling compounded tacrolimus eye drops because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Tacrolimus (0.02% and 0.03%) drops, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-685-2013·2013-07-17

    Fresenius Kabi Recalls Benztropine Mesylate Injection Due to Glass Particulates

    Fresenius Kabi is recalling 65,110 vials of Benztropine Mesylate Injection due to the presence of glass particulate matter. The affected vials were distributed nationwide and in Puerto Rico.

    Product
    BENZTROPINE MESYLATE — BENZTROPINE MESYLATE (BENZTROPINE MESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-733-2013·2013-07-17

    Olympia Pharmacy Recalls Gentamicin Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling two lots of Gentamicin 300 mg/ml Injection due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Gentamicin 300 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-727-2013·2013-07-17

    Olympia Pharmacy Recalls Estradiol Cypionate Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Estradiol Cypionate 10 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Estradiol Cypionate 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-697-2013·2013-07-17

    Olympia Pharmacy Recalls Amikacin Sulfate Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Amikacin Sulfate 250 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Amikacin Sulfate 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-793-2013·2013-07-17

    Olympia Pharmacy Recalls Vitamin B-Buildup Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Vitamin B-Buildup Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Vitamin B-Buildup Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1655-2013·2013-07-17

    Treasured Harvest Raw Shelled Pistachios Recalled for Salmonella Contamination

    Western Mixers Produce & Nuts, Inc. is recalling Treasured Harvest Raw Shelled Pistachios due to potential Salmonella contamination. The recall covers 1lb and 5lb cartons distributed in nine states.

    Product
    Treasured Harvest-Raw, Shelled Pistachios, 5lbs & 1lb, 1 per carton
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Devices)·Z-1669-2013·2013-07-17

    Cardio Medical Products Defibrillator Electrodes Recalled for Arcing and Sparking

    Cardio Medical Products is recalling 657 defibrillator electrodes due to reports of arcing and sparking on the leadwire.

    Product
    Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-777-2013·2013-07-17

    Olympia Pharmacy Recalls Progesterone Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling a specific lot of compounded Progesterone EO 100 mg/ml Injection due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Progesterone EO 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-780-2013·2013-07-17

    Olympia Pharmacy Recalls Sodium Iodide 20% Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Sodium Iodide 20% Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Sodium Iodide 20% Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-692-2013·2013-07-17

    Olympia Pharmacy Recalls Acetyl-D-Glucosamine Due to Sterility Concerns

    Olympia Pharmacy is recalling Acetyl-D-Glucosamine w/Chondroitin 200 mg/ml because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Acetyl-D-Glucosamine w/Chondroitin 200 mg/ml, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-781-2013·2013-07-17

    Sodium Salicylate Injection Recalled for Sterility Concerns

    Olympia Pharmacy is recalling Sodium Salicylate 40% Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Sodium Salicylate 40% Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-748-2013·2013-07-17

    Lipotoxin Injection Recalled Due to Sterility Concerns

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

    Product
    Lipotoxin Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-726-2013·2013-07-17

    Olympia Pharmacy Recalls Enrofloxacin Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Enrofloxacin 20 mg/ml Injection because FDA inspection findings raised concerns about quality control and assurance of sterility.

    Product
    Enrofloxacin 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-792-2013·2013-07-17

    Olympia Pharmacy Recalls Vitamin B12 Injections Due to Sterility Concerns

    Olympia Pharmacy is recalling Vitamin B12 Cyanocobalamin 5000 mcg Injections because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Vitamin B12 Cyanocobalamin 5000 mcg Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-706-2013·2013-07-17

    Olympia Pharmacy Recalls Bi Mix Due to Sterility Concerns

    Olympia Pharmacy is recalling Bi Mix compounded in Orlando, FL, due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Bi mix, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-725-2013·2013-07-17

    Olympia Pharmacy Recalls Doxapram Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Doxapram 20 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Doxapram 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-717-2013·2013-07-17

    Olympia Pharmacy Recalls Detomidine Injection Due to Sterility Concerns

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

    Product
    Detomidine 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-696-2013·2013-07-17

    Olympia Pharmacy Recalls Altrenogest Injection Due to Sterility Concerns

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

    Product
    Altrenogest 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1657-2013·2013-07-17

    Torn & Glasser Recalls Pistachios Due to Salmonella Contamination Risk

    Torn & Glasser Inc. is recalling specific brands of roasted and salted pistachios because they may be contaminated with Salmonella. The affected products were distributed in California, Arizona, and Hawaii.

    Product
    Roasted and Salted Pistachios packed under the following brand names and packaging: Sprouts Brand Roasted & Salted Pistachios, various weights. into 12 individual plastic bags with various weights per unit, then packaged into 10 lbs cardboard box. . Sun Harvest Brand…
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-749-2013·2013-07-17

    Lisinopril Injection Recalled for Sterility Assurance Concerns

    Olympia Pharmacy is recalling Lisinopril 20 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Lisinopril 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-695-2013·2013-07-17

    Olympia Pharmacy Recalls Alprostadil Due to Sterility Concerns

    Olympia Pharmacy is recalling Alprostadil 2000 mcg/ml because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Alprostadil 2000 mcg/ml, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-705-2013·2013-07-17

    Olympia Pharmacy Recalls Betamethasone Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Betamethasone Phosphate/Acetate 6 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Betamethasone Phosphate/Acetate 6 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-796-2013·2013-07-17

    Olympia Pharmacy Recalls Yohimbine Injection Due to Sterility Concerns

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

    Product
    Yohimbine 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide