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 and Bupivacaine solution due to FDA inspection findings of GMP violations affecting sterility.
The Compounding Pharmacy of America is recalling Tri-Mix ST4/PGE 2/LIDO 2 0.1/0.05/0.05 Injectable due to lack of assurance of sterility identified during an FDA inspection.
The Compounding Pharmacy of America is recalling Vitatrim Active Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Bi-Mix (20/1) Injectable due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling Morphine and Clonidine solution due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling a compounded intrathecal pain solution because an FDA inspection found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Hydromorphone and Baclofen Intrathecal Solution because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Cyanocobalamin 10 mg Pellets because an FDA inspection found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Tri-Mix Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone Cypionate 50 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Morphine and Fentanyl solution due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Tri-Mix injectable vials because FDA inspections found GMP violations that may affect sterility and product quality.
The Compounding Pharmacy of America is recalling Hydromorphone and Bupivacaine solution due to FDA inspection findings of GMP violations that impact sterility assurance.
The Compounding Pharmacy of America is recalling Testosterone 37.5 mg sterile pellets due to FDA inspection findings of GMP violations that may impact sterility.
Stealth Trailers is recalling 165 model year 2016 trailers because wheel studs may break, potentially causing the wheel to detach and increasing crash risk.
The Compounding Pharmacy of America is recalling Hydromorphone and Bupivacaine solution because an FDA inspection found violations that may affect sterility.
The Compounding Pharmacy of America is recalling Estradiol 8 mg sterile pellets due to GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone 200 mg sterile pellets due to GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling 5-MTHF injectable vials because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling MIC-PLUS Carnitine Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Alprostadil 40 mcg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Methylcobalamin and Methyl Tetrahydrofolate injectable vials because an FDA inspection found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Morphine and Clonidine solution nationwide due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Methionine, Inositol, and Choline injectable vials because FDA inspections found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone 62.5 mg Pellets because an FDA inspection found GMP violations that may affect sterility.