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.

23151–23175 of 32176

  • SevereFDA (Drugs)·D-610-2015·2015-04-29

    Attix Pharmaceuticals Recalls Dantrolene Sodium Due to Penicillin Cross-Contamination Risk

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

    Product
    Dantrolene Sodium 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-744-2015·2015-04-29

    Attix Pharmaceuticals Recalls Ketotifen Fumarate Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling all lots of Ketotifen Fumarate active pharmaceutical ingredient distributed between January 5, 2012, and February 12, 2015, due to potential penicillin cross-contamination.

    Product
    Ketotifen Fumarate 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-845-2015·2015-04-29

    Attix Pharmaceuticals Recalls Piroxicam Due to Penicillin Cross-Contamination Risk

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

    Product
    Piroxicam 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-943-2015·2015-04-29

    Attix Pharmaceuticals Recalls Trichlormethiazide Due to Penicillin Cross-Contamination Risk

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

    Product
    Trichlormethiazide 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-677-2015·2015-04-29

    Fluconazole API Recalled for Potential Penicillin Cross Contamination

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

    Product
    Fluconazole 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-801-2015·2015-04-29

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

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

    Product
    Mirtazapine 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-619-2015·2015-04-29

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

    Attix Pharmaceuticals is recalling Demeclocycline HCl active pharmaceutical ingredient due to potential penicillin cross-contamination from repackaging in a shared facility.

    Product
    Demeclocycline 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-901-2015·2015-04-29

    Attix Pharmaceuticals Recalls Sodium Starch Glycolate Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Sodium Starch Glycolate pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Sodium Starch Glycolate 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-743-2015·2015-04-29

    Attix Pharmaceuticals Recalls Ketorolac Tromethamine Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling all lots of Ketorolac Tromethamine active pharmaceutical ingredient distributed between January 5, 2012, and February 12, 2015, due to potential penicillin cross-contamination.

    Product
    Ketorolac Tromethamine 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-814-2015·2015-04-29

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

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

    Product
    Natamycin 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-637-2015·2015-04-29

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

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

    Product
    Domperidone 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-821-2015·2015-04-29

    Attix Pharmaceuticals Recalls Ofloxacin Due to Penicillin Cross-Contamination Risk

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

    Product
    Ofloxacin 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-877-2015·2015-04-29

    Attix Pharmaceuticals Recalls Reserpine Due to Penicillin Cross-Contamination Risk

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

    Product
    Reserpine 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-661-2015·2015-04-29

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

    Attix Pharmaceuticals is recalling all lots of Ethinyl Estradiol active pharmaceutical ingredient distributed between January 5, 2012, and February 12, 2015, due to potential penicillin cross-contamination.

    Product
    Ethinyl Estradiol 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-893-2015·2015-04-29

    Sildenafil Citrate Recalled for Potential Penicillin Cross Contamination

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

    Product
    Sildenafil 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-827-2015·2015-04-29

    Attix Pharmaceuticals Recalls Oseltamivir Phosphate Due to Penicillin Cross-Contamination Risk

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

    Product
    Oseltamivir 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 (Drugs)·D-705-2015·2015-04-29

    Attix Pharmaceuticals Recalls Histamine Diphosphate Due to Penicillin Cross-Contamination Risk

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

    Product
    Histamine Diphosphate 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-699-2015·2015-04-29

    Attix Pharmaceuticals Recalls Gemfibrozil Due to Penicillin Cross-Contamination Risk

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

    Product
    Gemfibrozil 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-880-2015·2015-04-29

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

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

    Product
    Rifaximin 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-911-2015·2015-04-29

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

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

    Product
    Tadalafil 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-548-2015·2015-04-29

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

    Attix Pharmaceuticals is recalling all lots of Bromhexine HCl active pharmaceutical ingredient distributed between January 5, 2012, and February 12, 2015, due to potential penicillin cross-contamination.

    Product
    Bromhexine 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-742-2015·2015-04-29

    Attix Pharmaceuticals Recalls Ketoprofen Due to Penicillin Cross-Contamination Risk

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

    Product
    Ketoprofen 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-908-2015·2015-04-29

    Attix Pharmaceuticals Recalls Sulfisoxazole Due to Penicillin Cross-Contamination Risk

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

    Product
    Sulphafurazole (Sulfisoxazole) 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-656-2015·2015-04-29

    Attix Pharmaceuticals Recalls Estriol Due to Penicillin Cross-Contamination Risk

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

    Product
    Estriol 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-749-2015·2015-04-29

    Attix Pharmaceuticals Recalls Lanthanum Carbonate Due to Penicillin Cross-Contamination Risk

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

    Product
    Lanthanum Carbonate 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