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 Hydromorphone and Bupivacaine solution because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Vitatrim Injection because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling a sterile morphine, ropivacaine, and baclofen solution because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Biotin 10 mg/ml Injectable due to GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling LIPO-VITE III Injection because an FDA inspection found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Tri-Mix T-101 Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling HCG 5,000 IU/ml injections due to FDA inspection findings regarding sterility assurance and GMP violations.
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 Morphine 10 mg/ml Solution due to FDA inspection findings regarding GMP violations and lack of sterility assurance.
The Compounding Pharmacy of America is recalling Hydromorphone 12.5 mg/ml Solution due to FDA inspection findings regarding GMP violations and lack of sterility assurance.
The Compounding Pharmacy of America is recalling Sufentanil 50 mcg/ml Solution due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling HCG 1,000 IU/ml Injection vials due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Tri-Mix ST1 Injectable due to GMP violations identified by FDA that may impact sterility.
The Compounding Pharmacy of America is recalling Morphine, Bupivacaine, and Clonidine solution due to FDA inspection findings of GMP violations affecting sterility.
The Compounding Pharmacy of America is recalling Myers Cocktail Injection due to FDA inspection findings regarding GMP violations and lack of sterility assurance.
The Compounding Pharmacy of America is recalling HCG and Methylcobalamin injections nationwide because FDA inspections found violations that may have compromised product sterility.
The Compounding Pharmacy of America is recalling Fentanyl intrathecal solution because an FDA inspection found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Hydromorphone and Bupivacaine solution because an FDA inspection found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Ascorbic Acid, Glutathione, and DMSO Ophthalmic Solution due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling compounded intrathecal solutions 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 impact sterility.
The Compounding Pharmacy of America is recalling Morphine 12.5 mg/ml Solution due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Hydromorphone and Bupivacaine solution due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Tri-Mix T-50/PGE 1 0.14/0.08 Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling a sterile morphine and bupivacaine solution because FDA inspections found violations that may affect sterility.