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.

23226–23250 of 32176

  • SevereFDA (Drugs)·D-738-2015·2015-04-29

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

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

    Product
    Isoxsuprine 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-889-2015·2015-04-29

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

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

    Product
    Secretin 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-828-2015·2015-04-29

    Attix Pharmaceuticals Recalls Oxcarbazepine Due to Penicillin Cross-Contamination Risk

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

    Product
    Oxcarbazepine 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-959-2015·2015-04-29

    Attix Pharmaceuticals Recalls Zolmitriptan Due to Penicillin Cross-Contamination Risk

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

    Product
    Zolmitriptan 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-509-2015·2015-04-29

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

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

    Product
    Amantadine 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-843-2015·2015-04-29

    Pioglitazone HCl Recalled for Potential Penicillin Cross Contamination

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

    Product
    Pioglitazone 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-840-2015·2015-04-29

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

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

    Product
    Phenoxybenzamine 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-692-2015·2015-04-29

    Attix Pharmaceuticals Recalls Formoterol Fumarate Dihydrate Due to Penicillin Cross-Contamination Risk

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

    Product
    Formoterol Fumarate 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 (Devices)·Z-1492-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Spec Deviations

    Wright Medical Technology is recalling 270 units of the Crosscheck Plating System because specific dimensions are out of specification, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, MTP CX Plate, Left, REF CCP-MPX1L. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-696-2015·2015-04-29

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

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

    Product
    Gabapentin 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-588-2015·2015-04-29

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

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

    Product
    Ciprofloxacin 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-632-2015·2015-04-29

    Attix Pharmaceuticals Recalls Diphemanil Methylsulfate Due to Penicillin Cross-Contamination Risk

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

    Product
    Diphemanil Methylsulfate 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-878-2015·2015-04-29

    Retinoic Acid Recalled for Potential Penicillin Cross Contamination

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

    Product
    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-576-2015·2015-04-29

    Attix Pharmaceuticals Recalls Chloramphenicol Palmitate Due to Penicillin Cross-Contamination Risk

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

    Product
    Chloramphenicol Palmitate 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-505-2015·2015-04-29

    Attix Pharmaceuticals Recalls Bovine Albumin Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling all lots of Bovine Albumin repackaged between January 2012 and February 2015 due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Albumin (Bovine) 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-0490-2015·2015-04-29

    Hospira Recalls Sodium Chloride Injection Due to Sterility Concerns

    Hospira Inc. is recalling 128,050 units of 0.9% Sodium Chloride Injection due to a potential leak at the administrative port that compromises sterility.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-875-2015·2015-04-29

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

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

    Product
    Ranitidine 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-776-2015·2015-04-29

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

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

    Product
    Meloxicam 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-791-2015·2015-04-29

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

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

    Product
    Methylprednisolone 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-535-2015·2015-04-29

    Attix Pharmaceuticals Recalls Belladonna Extract Powder Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Belladonna Extract Powder because it was repackaged in a facility with penicillin products without adequate separation, creating a risk of cross-contamination.

    Product
    Belladonna Extract Powder 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-633-2015·2015-04-29

    Attix Pharmaceuticals Recalls Diphenylcyclopropenone Due to Penicillin Cross-Contamination Risk

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

    Product
    Diphenylcyclopropenone 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-885-2015·2015-04-29

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

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

    Product
    Ropivacaine 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-0965-2015·2015-04-29

    SCA Pharmaceuticals Recalls Droperidol Injection Due to Particulate Presence

    SCA Pharmaceuticals is recalling 421 syringes of Droperidol injection because of the presence of particulate matter. The product was distributed in Indiana, Arkansas, Missouri, and Minnesota.

    Product
    Droperidol injection, 2.5 mg/mL, 5 mg Total Dose, 2 mL Fill Volume per syringe, packaged in 10-count syringes per heat sealed bag, RX only; Compounded for Office Use by SCA Pharmaceuticals, Little Rock, AR (877 ) 550-5059 Bar Code 88888-7720-16
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-904-2015·2015-04-29

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

    Attix Pharmaceuticals is recalling Streptomycin Sulfate API because it was repackaged in a facility with penicillin products without adequate separation, creating a cross-contamination risk.

    Product
    Streptomycin Sulfate or Sulphate 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-731-2015·2015-04-29

    Attix Pharmaceuticals Recalls Imiquimod Due to Penicillin Cross Contamination Risk

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

    Product
    Imiquimod 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