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.

23301–23325 of 32176

  • SevereFDA (Drugs)·D-655-2015·2015-04-29

    Attix Pharmaceuticals Recalls Estradiol Cypionate Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Estradiol Cypionate active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Estradiol Cypionate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-676-2015·2015-04-29

    Attix Pharmaceuticals Recalls Floxuridine Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling all lots of Floxuridine active pharmaceutical ingredient distributed between January 2012 and February 2015 due to potential penicillin cross-contamination.

    Product
    Floxuridine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-578-2015·2015-04-29

    Attix Pharmaceuticals Recalls Chlorobutanol Hemihydrate Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Chlorobutanol Hemihydrate pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Chlorobutanol Hemihydrate pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-668-2015·2015-04-29

    Attix Pharmaceuticals Recalls Everolimus API Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling all lots of everolimus active pharmaceutical ingredient distributed between January 2012 and February 2015 due to potential penicillin cross-contamination.

    Product
    Everolimus active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-757-2015·2015-04-29

    Attix Pharmaceuticals Recalls Levodopa API Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Levodopa active pharmaceutical ingredient lots distributed between January 2012 and February 2015 due to potential penicillin cross-contamination during repackaging.

    Product
    Levodopa or L-Dihydroxyphenylalanine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-493-2015·2015-04-29

    Attix Pharmaceuticals Recalls 2-Deoxy-D-Glucose Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling 2-Deoxy-D-Glucose active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    2-Deoxy-D-Glucose active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, On
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1457-2015·2015-04-29

    Siemens ADVIA Chemistry Lipase Reagent Recalled for Carryover Contamination

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Lipase Reagent because carryover from other reagents can cause falsely elevated test results.

    Product
    ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-654-2015·2015-04-29

    Attix Pharmaceuticals Recalls Estradiol Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Estradiol (Non-Micronized) active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Estradiol (Non-Micronized) active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-740-2015·2015-04-29

    Kanamycin Sulfate Recalled Due to Potential Penicillin Cross Contamination

    Attix Pharmaceuticals is recalling Kanamycin Sulfate active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Kanamycin Sulfate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-702-2015·2015-04-29

    Halobetasol Propionate Recalled for Potential Penicillin Cross Contamination

    Attix Pharmaceuticals is recalling Halobetasol Propionate active ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Halobetasol Propionate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-532-2015·2015-04-29

    Attix Pharmaceuticals Recalls Azelastine HCl Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Azelastine HCl active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Azelastine HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-912-2015·2015-04-29

    Attix Pharmaceuticals Recalls Tadalafil Citrate Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Tadalafil Citrate active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Tadalafil Citrate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-624-2015·2015-04-29

    Attix Pharmaceuticals Recalls Dexamethasone Sodium Phosphate Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Dexamethasone Sodium Phosphate active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Dexamethasone Sodium Phosphate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1494-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Specification Defects

    Wright Medical Technology is recalling 233 units of the Crosscheck Plating System because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-951-2015·2015-04-29

    Attix Pharmaceuticals Recalls Vecuronium Bromide Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Vecuronium Bromide active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Vecuronium Bromide active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-723-2015·2015-04-29

    Attix Pharmaceuticals Recalls Hydroxyurea Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Hydroxyurea active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Hydroxyurea active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-526-2015·2015-04-29

    Atazanavir API Recalled for Potential Penicillin Cross Contamination

    Attix Pharmaceuticals is recalling Atazanavir active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Atazanavir active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-605-2015·2015-04-29

    Attix Pharmaceuticals Recalls Cyclobenzaprine HCI Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling all lots of Cyclobenzaprine HCI repackaged between January 2012 and February 2015 due to potential penicillin cross-contamination.

    Product
    Cyclobenzaprine HCI active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-797-2015·2015-04-29

    Attix Miconazole Nitrate Recalled for Potential Penicillin Cross Contamination

    Attix Pharmaceuticals is recalling Miconazole Nitrate active ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Miconazole Nitrate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-812-2015·2015-04-29

    Attix Pharmaceuticals Recalls Naproxen Base Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Naproxen Base active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Naproxen Base active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-819-2015·2015-04-29

    Attix Pharmaceuticals Recalls Nitrofurantoin Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Nitrofurantoin active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging. The recall affects lots distributed nationwide to compounding pharmacies and research organizations.

    Product
    Nitrofurantoin active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-599-2015·2015-04-29

    Attix Pharmaceuticals Recalls Colchicine API Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling colchicine active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging. The product was distributed to compounding pharmacies and research organizations.

    Product
    Colchicine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-536-2015·2015-04-29

    Attix Pharmaceuticals Recalls Benazepril API Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Benazepril active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Benazepril active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-539-2015·2015-04-29

    Attix Pharmaceuticals Recalls Benztropine Mesylate Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Benztropine Mesylate active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Benztropine Mesylate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-552-2015·2015-04-29

    Attix Pharmaceuticals Recalls Bupivacaine HCl Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Bupivacaine HCl active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Bupivacaine HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide