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.
Downing Labs, LLC is recalling 320 vials of Magnesium Sulfate 50% Injectable because the company cannot assure the sterility of the product.
US Compounding Inc is recalling MIC Combo multi-dose vials because deficient practices may have impacted sterility assurance.
US Compounding Inc is recalling 96 vials of Bi-Mix sterile preparations nationwide due to deficient practices that may impact sterility assurance.
Downing Labs, LLC is recalling 178 vials of Folic Acid Injection because the company cannot ensure the product is sterile. The recall covers all lots distributed in the US and 17 other countries.
US Compounding Inc is recalling 1,093 vials of Trace Elements-4 IV injection due to deficient practices that may impact sterility assurance.
FDA is recalling HCG 2000 Units/mL Injection vials from Essential Wellness Pharmacy due to poor sterile production practices.
US Compounding Inc is recalling 5,919 vials of Morphine PF due to deficient practices that may impact sterility assurance.
Downing Labs, LLC is recalling Thiamine HCl Injection, 100mg/mL, 30mL vials because the company cannot assure the sterility of the product.
Kronos Foods is recalling Baklava Sample Assortments due to a potential for metal fragments discovered after increased metal detector rejections.
Kalman Health & Wellness is recalling 20 vials of Testosterone Injection due to poor sterile production practices that compromised sterility assurance.
Downing Labs, LLC is recalling Green Tea (EGCG) Injectable vials because the company cannot ensure the product is sterile. The recall covers 23 vials distributed in the US and internationally.
Kar Nut Products Company is recalling 74,333 boxes of Kar's Sweet n' Salty Mix due to the possibility of very small pieces of glass in the product.
Downing Labs, LLC is recalling EDTA Disodium Injectable vials because the company cannot ensure the product is sterile.
US Compounding Inc is recalling 82 vials of Alprostadil (PGE-1) nationwide due to deficient practices that may impact sterility assurance.
Vaughan Foods is recalling Timeless Garden Salad Kits due to a potential Salmonella contamination risk. The product was distributed in six states.
US Compounding Inc is recalling 5,514 vials of Betamethasone Combo PF 2 mL due to deficient practices that may impact sterility assurance.
Downing Labs, LLC is recalling 287 vials of Sermorelin/GHRP-6/GHRP-2 Injection due to a lack of assurance of sterility. The product was distributed nationwide and in multiple international locations.
Essential Wellness Pharma is recalling HCG 3000 Units/mL Injection vials due to poor sterile production practices that compromised sterility assurance.
US Compounding Inc is recalling 15,640 vials of Neostigmine 5 mg/5 mL syringes nationwide due to deficient practices that may impact sterility assurance.
Downing Labs, LLC is recalling 98 vials of B12 Injection 12.5/12.5MG due to a lack of assurance of sterility. The product was distributed nationwide and internationally.
US Compounding Inc is recalling Betamethasone SP vials nationwide because deficient practices may have impacted sterility assurance.
Essential Wellness Pharma is recalling compounded progesterone injections due to poor sterile production practices that compromised sterility assurance.
Essential Wellness Pharmacy is recalling Methylcobalamin 5000 mcg/mL injections due to poor sterile production practices that compromised sterility assurance.
Downing Labs is recalling Methylcobalamin Buffered Injectable vials because the company cannot guarantee the product is sterile.
Chrysler is recalling 2015 Ram ProMaster vans because an ignition switch defect may cause the vehicle to stall or disable safety systems like airbags and anti-lock brakes.