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.
South Coast Specialty Compounding is recalling Methylcobalamin Injection 5 mg/mL vials due to a lack of assurance of sterility. The affected products were distributed in California and Indiana.
Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection vials because the company cannot guarantee the product is sterile.
Beacon Hill Medical Pharmacy is recalling Dexpantenol 250 mg/mL injectable products because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.
Beacon Hill Medical Pharmacy is recalling Hyaluronidase 150 U/ML and 200 U/ML Injectable due to FDA inspectional findings regarding quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling compounded buprenorphine cream due to sterility assurance concerns identified during an FDA inspection.
Beacon Hill Medical Pharmacy is recalling Phosphatidylcholine 50 mg/mL Injectable because FDA inspections raised concerns about quality control and sterility assurance.
Siemens is recalling Microscan Synergies Plus Negative panels due to confirmed false susceptible and intermediate results for imipenem and meropenum.
Beacon Hill Medical Pharmacy is recalling compounded estradiol cypionate injections due to FDA inspectional findings regarding quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling Chromium 4 mcg/mL Injectable due to FDA inspectional findings regarding sterility assurance.
Navistar is recalling 2008-2013 International LoneStar, ProStar, and TranStar trucks because an assembly error in the air lines may cause the fifth wheel jaw to release unexpectedly, increasing crash risk.
Beacon Hill Medical Pharmacy is recalling compounded cyanocobalamin injections because FDA inspections raised concerns about sterility assurance and quality control.
Beacon Hill Medical Pharmacy is recalling Glycyrrhizic Acid 8 mg/mL Injectable because FDA inspectional findings raised concerns about sterility assurance.
Siemens Healthcare Diagnostics is recalling Microscan Synergies Plus Negative Combo 2 panels due to confirmed false susceptible and intermediate misreads for Imipenem and meropenum.
Beacon Hill Medical Pharmacy is recalling Oxytocin 10 Units/mL because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.
Beacon Hill Medical Pharmacy is recalling Arginine (R-Gene) 100 mg/mL injectable because FDA inspectional findings raised concerns about sterility assurance.
Siemens Healthcare Diagnostics is recalling Microscan Synergies Plus Negative Urine Combo 2 panels due to confirmed false susceptible and intermediate misreads for imipenem and meropenum.
FDA is recalling Monoject 100 Units/mL Heparin Lock Flush syringes because they may contain non-sterile water. The products are distributed in the USA and Bermuda.
Beacon Hill Medical Pharmacy is recalling Sodium Phosphate Dibasic/Water for Injection 10% because FDA inspections raised concerns about quality control and sterility assurance.
Spartan Motors is recalling 2011-2013 Transit Bus Chassis Cabs because front sway bar fasteners may loosen, potentially damaging brake lines and increasing crash risk.
Beacon Hill Medical Pharmacy is recalling Methylprednisolone Acetate injectable products because FDA inspectional findings raised concerns about quality control procedures that impacted sterility assurance.
Beacon Hill Medical Pharmacy is recalling B-Complex/Lido/B-12 injectable products because FDA inspections raised concerns about quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling compounded glutathione/methyl/lido injectable solutions because FDA inspections raised concerns about sterility assurance.
University Compounding Pharmacy is voluntarily recalling Testosterone Cypionate Injection due to lack of assurance of sterility. The recall affects 178.2 mL of the product nationwide.
Beacon Hill Medical Pharmacy is recalling progesterone 50 mg/mL oil injection solution because FDA inspectional findings raised concerns about sterility assurance and quality control procedures.
Daimler Trucks North America is recalling 2013 Thomas Built Minotour school buses because floor sheet metal may not be properly bonded, increasing injury risk in a crash.