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 Testosterone 200 mg Anastrazole 9 mg Pellets because an FDA inspection found GMP 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.
The Compounding Pharmacy of America is recalling Tri-Mix ST9C Injectable nationwide due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling MEGA-BURN Injectable ROCK CREEK because FDA inspections found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Sodium Ascorbate 500 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Baclofen 2,500 mcg/ml Intrathecal Solution due to FDA inspection findings regarding GMP violations and lack of sterility assurance.
The Compounding Pharmacy of America is recalling Buckshot Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Lidocaine 1% Injection because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Tri-Mix Injectable due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling Sermorelin and GHRP-2 injections due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Hydroxyprogesterone Caproate injectable vials because FDA inspections found GMP violations that may compromise sterility.
The Compounding Pharmacy of America is recalling Hydromorphone, Fentanyl, and Bupivacaine Intrathecal Solution because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Hyaluronic Acid Sodium and Lidocaine HCl Injection because an FDA inspection found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling HCG and Methylcobalamin injections due to FDA inspection findings regarding sterility assurance.
The Compounding Pharmacy of America is recalling Tri-Mix injectable products due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling a compounded morphine and fentanyl solution because FDA inspections found GMP violations that may affect 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 625 IU/ml Injection vials nationwide because an FDA inspection identified GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone Cypionate 150 mg/ml Injection due to lack of assurance of sterility identified during an FDA inspection.
The Compounding Pharmacy of America is recalling Magnesium Sulfate 500 mg/ml Injectable due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling HCG and Methylcobalamin injections due to FDA inspection findings regarding sterility and quality.
The Compounding Pharmacy of America is recalling Hydromorphone 15 mg/ml Solution because FDA inspections found violations that may affect 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 Morphine and Bupivacaine Solution due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling Neomycin + Polymyxin B + Bacitracin Ophthalmic Ointment because FDA inspections found GMP violations that may affect sterility.