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.
Beacon Hill Medical Pharmacy is recalling Bi-Tropin S-2 Injectable due to FDA inspectional findings regarding quality control and sterility assurance.
Cardiogenesis Corporation is recalling 2,498 Transmyocardial Laser devices due to reports of sparks, burns, or smoke incidents.
Beacon Hill Medical Pharmacy is recalling Lipolic Acid injectable products because FDA inspections raised concerns about sterility assurance and quality control.
Beacon Hill Medical Pharmacy is recalling PUMICE/LIDOCAINE HCL 1.5%/1% Injection Suspensions because FDA inspections raised concerns about sterility assurance.
Beacon Hill Medical Pharmacy is recalling Sodium Phosphate Monobasic/Water for Injection 10% because FDA inspections raised concerns about sterility assurance and quality control.
Beacon Hill Medical Pharmacy is recalling Nalbuphine HCL 20 mg/mL injectable because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.
Beacon Hill Medical Pharmacy is recalling Calcium EDTA 200 mg/mL injectable products because FDA inspectional findings raised concerns about quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling compounded Triamcinolone Acetonide injections because FDA inspections raised concerns about sterility assurance.
Beacon Hill Medical Pharmacy is recalling Calcium EDTA 300 mg/mL Injectable because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.
Beacon Hill Medical Pharmacy is recalling Ascorbic Acid 500 mg/mL injectable products due to FDA inspectional findings regarding sterility assurance.
Beacon Hill Medical Pharmacy is recalling compounded testosterone cypionate injections due to FDA inspectional findings regarding sterility assurance and quality control.
Beacon Hill Medical Pharmacy is recalling Ketorolac Tromethamine 60 mg/mL injectable because FDA inspectional findings raised concerns about quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling Dual-Testosterone oil injection solutions due to FDA inspectional findings regarding quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling Estradiol Valerate with Lidocaine injection because FDA inspections raised concerns about sterility assurance.
Beacon Hill Medical Pharmacy is recalling Copper 0.4mg/mL Injectable due to FDA inspectional findings regarding quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling Vitamin B-Complex Injectable products because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.
Covidien LLC is recalling Monoject 0.9% Sodium Chloride Flush Syringes because they may contain non-sterile water. The products are distributed in the US and Bermuda.
Beacon Hill Medical Pharmacy is recalling Dexamethasone Sodium Phosphate 10 mg/mL injectable due to sterility assurance concerns identified during an FDA inspection.
South Coast Specialty Compounding is voluntarily recalling Testosterone Cypionate injections due to a lack of sterility assurance.
Beacon Hill Medical Pharmacy is recalling B-12 Rejuv 25 mg/mL injectable due to FDA inspectional findings regarding sterility assurance.
FDA Class II recall of Monoject 100 Units/mL Heparin Lock Flush syringes due to potential non-sterile water contamination.
Bubbles Baking Co. is recalling First Street Coffee Cake Muffins because they may contain undeclared pecan nuts. The recall covers 8,478 units distributed in California, Nevada, and Arizona.
Beacon Hill Medical Pharmacy is recalling compounded B12/E2/E3/PROG/TEST injectable solution due to FDA inspectional findings regarding sterility assurance.
Beacon Hill Medical Pharmacy is recalling MIC-CARN + B6/B12/LIDOCAINE injectable products because FDA inspections raised concerns about quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling Zinc Sulfate 1 mg/ml Injectable due to FDA inspectional findings regarding quality control and sterility assurance.