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 Estradiol 6 mg sterile pellets nationwide because FDA inspections found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Vancomycin 25 mg/ml Ophthalmic Solution due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Methylcobalamin and Hydroxocobalamin Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone USP injections due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Lipoderm Modified Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Tri-Mix T-105 Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling MEGA-BURN III Injection because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Fentanyl and Bupivacaine Intrathecal Solution due to FDA inspection findings of 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 Lipovicine Modified II Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone 18 mg sterile pellets due to GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Ascorbic Acid 500 mg/ml Injectable Vials nationwide due to FDA inspection findings regarding GMP violations and lack of sterility assurance.
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 200mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling a compounded intrathecal solution because an FDA inspection found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Hydromorphone 1 mg/ml Intrathecal Solution because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling DMPS injectable vials due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling HCG 1,000 IU/ml Injection kits because an FDA inspection identified 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 Bupivacaine and Baclofen intrathecal solution because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Morphine and Clonidine solution due to FDA inspection findings regarding sterility assurance.
The Compounding Pharmacy of America is recalling Tri-Mix MEDIUM injectable products due to FDA inspection findings of GMP violations that impact sterility assurance.
The Compounding Pharmacy of America is recalling MIC-B Complex Injectable vials because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling HCG 5,000 IU/ml injections due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling MYO-DEN Injection due to FDA inspection findings of GMP violations that may impact sterility and product quality.