Severity 4 of 5
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.
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.
The Compounding Pharmacy of America is recalling Morphine 30 mg/ml Solution because an FDA inspection found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Mitomycin Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Lipotropic B-12 Injection vials because an FDA inspection found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Estradiol Valerate 20 mg/ml injectable vials due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Collagenase 250 units/ml vials because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Estradiol 100 mg sterile pellets nationwide because FDA inspections found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Cholecalciferol 50,000 IU/ml Injectable vials because FDA inspections identified GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Estradiol 20 mg sterile pellets nationwide because FDA inspections identified GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Morphine and Bupivacaine solution because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling MEGA-BURN injectable vials because FDA inspections found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Sermorelin 1000 mcg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Cholecalciferol 500,000 IU/ml Injectable due to GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Methylcobalamin 5,000 mcg/ml Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Mitomycin Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Tri-Mix ST9E injectable products because an FDA inspection found violations that may affect sterility.
The Compounding Pharmacy of America is recalling LIPO-EXTREME Injectable due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling Tri-Mix ST9A Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Selenium 200 mcg/ml Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling PGE 150 (Alprostadil) due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling HCG 4,000 IU/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone 72.5 mg Pellets due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling Estradiol 25 mg sterile pellets nationwide due to GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling HCG 10,000 IU/ml Injection vials because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Morphine 15 mg/ml Solution due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling Hydromorphone 30 mg/ml Solution due to FDA inspection findings of GMP violations that may impact sterility.