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.
US Compounding Inc is recalling 1,096 vials of Hyaluronidase PF (150 units/mL) nationwide due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 1,590 syringes of Succinylcholine Chloride because deficient practices may have impacted sterility assurance.
Downing Labs, LLC is recalling 481 vials of TNPDR Injection Buffered because the company cannot ensure the product is sterile. The recall covers all lots distributed nationwide and internationally.
Downing Labs, LLC is recalling DMAE Dimethylaminoethanol Injection due to a lack of assurance of sterility. The recall affects 16 vials distributed nationwide and internationally.
Downing Labs, LLC is recalling Vitamin D3 Injectable, 10,000 U/mL, 10mL vials due to a lack of assurance of sterility. The product was distributed nationwide and internationally.
Downing Labs, LLC is recalling 74 vials of Zinc Sulfate Injection due to a lack of assurance of sterility. The product was distributed nationwide and internationally.
US Compounding Inc is recalling 265 vials of Methylcobalamin injection due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 235 vials of Dexamethasone Sodium Phosphate PF due to deficient practices that may impact sterility assurance.
Downing Labs, LLC is recalling MICML TRNDPPC Injection (Preserved) 10mL vials because the company cannot ensure the product is sterile.
Vaughan Foods is recalling 98 cases of Taboli (80 oz) due to a potential Salmonella contamination risk. The product was distributed in six states.
US Compounding Inc is recalling 494 syringes of Vancomycin Ophthalmic PF due to deficient practices that may impact sterility assurance.
Kanan Enterprises is recalling Mountain Mix trail mix products because they contain undeclared milk. The products were distributed to 21 states and Canada.
Downing Labs, LLC is recalling 20 vials of Glucosamine HCL Injectable because the product lacks assurance of sterility. The recall covers all lots distributed in the US and internationally.
Market of Choice Inc. is recalling 24 units of Baked Brie Herb/Garlic due to undeclared pecans. The product was distributed in Oregon.
Downing Labs, LLC is recalling 1,062 vials of HCG (Lyophilized) Injectable because the product lacks assurance of sterility. The recall covers all lots distributed nationwide and internationally.
Downing Labs, LLC is recalling Ascorbic Acid Injectable 500mg/mL vials due to a lack of assurance of sterility. The recall affects 4,857 vials distributed in the US and 17 other countries.
US Compounding Inc is recalling Phenylephrine PF Sterile Solution (2.5%) because deficient practices may have impacted sterility assurance.
US Compounding Inc is recalling 19,494 vials of Betamethasone Combo 10 mL due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 542 vials of Phenylephrine 1.5%/Lidocaine 1% for intracameral injection due to deficient practices that may impact sterility assurance.
Essential Wellness Pharma is recalling Testosterone CYP/ENAN/PROP Injection vials due to poor sterile production practices that compromise sterility assurance.
Downing Labs, LLC is recalling 225 vials of Potassium Chloride Injection due to a lack of assurance of sterility. The product was distributed nationwide and in multiple international markets.
Essential Wellness Pharmacy is recalling Progesterone 100 mg/mL injections due to poor sterile production practices that compromised sterility assurance.
Essential Wellness Pharmacy is recalling Methylcobalamin 1 mg/mL prefilled syringes due to poor sterile production practices that compromised sterility assurance.
S. Martinelli & Co is recalling Martinelli's Sparkling Northwest Blend Cider due to the potential for glass fragments in 8.4 oz bottles.
Kalman Health & Wellness is recalling Sermorelin injections due to poor sterile production practices that compromise sterility assurance.