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 Alprostadil 100 mcg/ml injections due to FDA inspection findings that may impact sterility.
The Compounding Pharmacy of America is recalling Quad-Mix 2 Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling HCG 2,000 IU/ml Injection vials because FDA inspections 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 Alprostadil 100 mcg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Fentanyl and Bupivacaine Intrathecal Solution due to GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Mannitol 5% Injectable vials because FDA inspections found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling LIPOLEAN + Ascorbic Acid injectable vials due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling Morphine and Bupivacaine solution due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling HCG and Methylcobalamin injections due to FDA inspection findings of 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.
Forest River is recalling 2009-2016 Cherokee and Vengeance trailers because an insufficient ground wire in the wiring harness may overheat, increasing the risk of fire and loss of brakes.
The Compounding Pharmacy of America is recalling Tri-Mix Injectable due to GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling SUPER LIPO Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Hydroxocobalamin and Folic Acid injectable vials due to FDA-identified GMP violations affecting sterility.
The Compounding Pharmacy of America is recalling L-Arginine 100 mg/ml Injectable vials because FDA inspections 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 Bi-Mix #1 Injectable due to FDA inspection findings of GMP violations that impact sterility assurance.
The Compounding Pharmacy of America is recalling Lipotropic Methyl B-12 Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling a compounded sterile solution containing morphine, fentanyl, bupivacaine, and clonidine due to GMP violations affecting sterility.
The Compounding Pharmacy of America is recalling Fentanyl 1,000 mcg/ml Intrathecal Solution because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Fentanyl and Bupivacaine intrathecal solution because an FDA inspection found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Morphine and Clonidine solution due to FDA inspection findings of GMP violations affecting sterility.
The Compounding Pharmacy of America is recalling Testosterone 75 mg and B12 6 mg Pellets due to FDA inspection findings regarding sterility assurance.
The Compounding Pharmacy of America is recalling Hydromorphone 5 mg/ml Solution because FDA inspections found GMP violations that may affect sterility.