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.

23076–23100 of 32176

  • SevereFDA (Drugs)·D-836-2015·2015-04-29

    Attix Pharmaceuticals Recalls Pentosan Polysulfate Sodium Due to Penicillin Cross-Contamination Risk

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

    Product
    Pentosan Polysulfate 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-657-2015·2015-04-29

    Attix Pharmaceuticals Recalls Estriol Due to Penicillin Cross-Contamination Risk

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

    Product
    Estriol (Ultra-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-818-2015·2015-04-29

    Attix Pharmaceuticals Recalls Nitazoxanide Due to Penicillin Cross-Contamination Risk

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

    Product
    Nitazoxanide 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-926-2015·2015-04-29

    Attix Pharmaceuticals Recalls Thimerosal Due to Penicillin Cross-Contamination Risk

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

    Product
    Thimerosal 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-856-2015·2015-04-29

    Prednisolone Anhydrous Recalled for Potential Penicillin Cross Contamination

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

    Product
    Prednisolone Anhydrous 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-805-2015·2015-04-29

    Attix Pharmaceuticals Recalls Mometasone Furoate Due to Penicillin Cross-Contamination Risk

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

    Product
    Mometasone Furoate 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-496-2015·2015-04-29

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

    Attix Pharmaceuticals is recalling 2,3-Dimercaptosuccinic Acid (DMSA) active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    2,3-Dimercaptosuccinic Acid (DMSA) 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-625-2015·2015-04-29

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

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

    Product
    Dexchlorpheniramine 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-663-2015·2015-04-29

    Attix Pharmaceuticals Recalls Etidronate Disodium Due to Penicillin Cross-Contamination Risk

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

    Product
    Etidronate Disodium 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-942-2015·2015-04-29

    Attix Pharmaceuticals Recalls Tretinoin Due to Penicillin Cross-Contamination Risk

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

    Product
    Tretinoin or All-Trans Retinoic 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-675-2015·2015-04-29

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

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

    Product
    Flibanserin 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-771-2015·2015-04-29

    Attix Pharmaceuticals Recalls Magnesium Stearate Due to Penicillin Cross-Contamination Risk

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

    Product
    Magnesium Stearate 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-897-2015·2015-04-29

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

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

    Product
    Sodium Dichloroacetate 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-822-2015·2015-04-29

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

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

    Product
    Olsalazine 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-813-2015·2015-04-29

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

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

    Product
    Naproxen 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-946-2015·2015-04-29

    Attix Pharmaceuticals Recalls Uridine-5'Triphosphate Trisodium Salt Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Uridine-5'Triphosphate Trisodium Salt active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Uridine-5'Triphosphate Trisodium Salt 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-890-2015·2015-04-29

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

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

    Product
    Seratonin 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 (Devices)·Z-1456-2015·2015-04-29

    OriGen VV13F Reinforced Dual Lumen Catheter Recalled for Separation Risk

    OriGen Biomedical is recalling 51 units of VV13F Reinforced Dual Lumen Catheters because the extension tube may separate from the hub, posing a risk of blood loss.

    Product
    OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. OriGene VV13F Reinforced Dual Lumen Catheter indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-628-2015·2015-04-29

    Attix Pharmaceuticals Recalls Dextran-70 Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Dextran-70 active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Dextran-70 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-513-2015·2015-04-29

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

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

    Product
    Aminocaproic 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-762-2015·2015-04-29

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

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

    Product
    Lidocaine 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-567-2015·2015-04-29

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

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

    Product
    Cefazolin 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-603-2015·2015-04-29

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

    Attix Pharmaceuticals is recalling Crotamiton active pharmaceutical ingredient due to potential penicillin cross-contamination from shared facility repackaging.

    Product
    Crotamiton 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-529-2015·2015-04-29

    Atropine Sulfate Recalled for Potential Penicillin Cross Contamination

    Attix Pharmaceuticals is recalling Atropine Sulfate Monohydrate USP active pharmaceutical ingredient due to potential penicillin cross contamination during repackaging.

    Product
    Atropine Sulfate Monohydrate USP 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-944-2015·2015-04-29

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

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

    Product
    Trifluridine 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