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 Mitomycin 0.03% Ophthalmic Solution due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling B-Complex Injection nationwide because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Morphine and Baclofen solution due to FDA inspection findings of GMP violations affecting sterility.
The Compounding Pharmacy of America is recalling Alprostadil 20 mcg/ml Injection because an FDA inspection identified GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Betamethasone Sodium Phosphate injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Hydroxocobalamin 1,000 mcg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Bupivacaine 15 mg/ml Intrathecal Solution due to FDA inspection findings regarding GMP violations and lack of sterility assurance.
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 Clonidine 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 Estradiol 3 mg sterile pellets due to GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Tri-Mix ST2 Injectable nationwide due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Polidocanol 1% Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling B-Complex 100 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling PGE 80 (Alprostadil) 80 mcg/ml Injection because an FDA inspection identified GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Sodium Tetradecyl Sulfate 5% Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Morphine 33 mg/ml Solution due to FDA inspection findings regarding sterility assurance.
The Compounding Pharmacy of America is recalling Fentanyl and Baclofen intrathecal solution due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Hydromorphone and Clonidine Intrathecal Solution because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Hydromorphone, Clonidine, and Baclofen intrathecal solution because FDA inspections found GMP violations that may have compromised sterility.
The Compounding Pharmacy of America is recalling Tri-Mix T-50/PGE 2/LIDO 2 0.03/0.18/0.09 Injectable because an FDA inspection identified GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Sufentanil and Bupivacaine Solution due to FDA inspection findings regarding sterility assurance.
The Compounding Pharmacy of America is recalling Fentanyl 500 mcg/ml Intrathecal Solution due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Morphine and Baclofen solution because an FDA inspection found violations that may affect sterility.
The Compounding Pharmacy of America is recalling Tri-Mix Injectable due to FDA inspection findings of GMP violations that may impact sterility.