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.

23326–23350 of 32176

  • SevereFDA (Drugs)·D-857-2015·2015-04-29

    Prednisolone API Recalled for Potential Penicillin Cross Contamination

    Attix Pharmaceuticals is recalling Prednisolone Anhydrous Micronized API due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Prednisolone Anhydrous 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-851-2015·2015-04-29

    Attix Pharmaceuticals Recalls Potassium Phosphate Monobasic Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling all lots of Potassium Phosphate Monobasic distributed between January 2012 and February 2015 due to potential penicillin cross-contamination.

    Product
    Potassium Phosphate Monobasic 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-569-2015·2015-04-29

    Attix Pharmaceuticals Recalls Cefpodoxime Proxetil Due to Penicillin Cross-Contamination Risk

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

    Product
    Cefpodoxime Proxetil 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-903-2015·2015-04-29

    Attix Pharmaceuticals Recalls Spectinomycin Sulfate Due to Penicillin Cross-Contamination Risk

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

    Product
    Spectinomycin 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-642-2015·2015-04-29

    Attix Pharmaceuticals Recalls Doxycycline Hyclate Due to Penicillin Cross-Contamination Risk

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

    Product
    Doxycycline Hyclate 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-755-2015·2015-04-29

    Attix Pharmaceuticals Recalls Levocetirizine Dihydrochloride Due to Penicillin Cross-Contamination Risk

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

    Product
    Levocetirizine Dihydrochloride 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-838-2015·2015-04-29

    Attix Pharmaceuticals Recalls Pheniramine Maleate Due to Penicillin Cross-Contamination Risk

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

    Product
    Pheniramine Maleate 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-684-2015·2015-04-29

    Fluoxetine Hydrochloride Recalled for Potential Penicillin Cross Contamination

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

    Product
    Fluoxetine Hydrochloride 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-752-2015·2015-04-29

    Attix Pharmaceuticals Recalls Leucovorin Calcium Due to Penicillin Cross-Contamination Risk

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

    Product
    Leucovorin Calcium 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-726-2015·2015-04-29

    Attix Pharmaceuticals Recalls Hyoscyamine Sulfate Due to Penicillin Cross-Contamination Risk

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

    Product
    Hyoscyamine Sulfate Dihydrate 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-626-2015·2015-04-29

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

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

    Product
    Dexmedetomidine 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-635-2015·2015-04-29

    Attix Pharmaceuticals Recalls Dobutamine Hydrochloride Due to Penicillin Cross-Contamination Risk

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

    Product
    Dobutamine Hydrochloride 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-557-2015·2015-04-29

    Attix Pharmaceuticals Recalls Calcium Sulfate Hemihydrate Due to Penicillin Cross-Contamination Risk

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

    Product
    Calcium Sulfate Hemihydrate 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-849-2015·2015-04-29

    Attix Pharmaceuticals Recalls Potassium Acetate Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling all lots of Potassium Acetate active pharmaceutical ingredient distributed between January 5, 2012, and February 12, 2015, due to a risk of penicillin cross-contamination.

    Product
    Potassium Acetate 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-934-2015·2015-04-29

    Attix Pharmaceuticals Recalls Tolfenamic Acid Due to Penicillin Cross-Contamination Risk

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

    Product
    Tolfenamic Acid 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-563-2015·2015-04-29

    Attix Pharmaceuticals Recalls Carboxymethyl Cellulose Sodium Due to Penicillin Cross-Contamination Risk

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

    Product
    Carboxymethyl Cellulose 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-491-2015·2015-04-29

    Attix Pharmaceuticals Recalls 5-Aminolevulinic Acid Hydrochloride Due to Penicillin Cross-Contamination

    Attix Pharmaceuticals is recalling 5-Aminolevulinic Acid Hydrochloride active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    5-Aminolevulinic Acid Hydrochloride 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-736-2015·2015-04-29

    Attix Pharmaceuticals Recalls Isoproterenol Hydrochloride Due to Penicillin Cross-Contamination Risk

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

    Product
    Isoproterenol Hydrochloride 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-747-2015·2015-04-29

    Attix Pharmaceuticals Recalls Lamotrigine Ingredient Due to Penicillin Cross-Contamination Risk

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

    Product
    Lamotrigine 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-879-2015·2015-04-29

    Ribavirin Recalled for Potential Penicillin Cross Contamination

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

    Product
    Ribavirin 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-549-2015·2015-04-29

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

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

    Product
    Bromocriptine 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-765-2015·2015-04-29

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

    Attix Pharmaceuticals is recalling Liothyronine Sodium (T3) active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Liothyronine Sodium (T3) 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-531-2015·2015-04-29

    Attix Pharmaceuticals Recalls Azatadine Maleate Due to Penicillin Cross-Contamination Risk

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

    Product
    Azatadine Maleate 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-523-2015·2015-04-29

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

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

    Product
    Aprepitant 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-811-2015·2015-04-29

    Attix Pharmaceuticals Recalls Naftifine HCl Due to Penicillin Cross Contamination

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

    Product
    Naftifine 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