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.
Essential Wellness Pharma is recalling QUAD MIX Injection vials because poor sterile production practices may have compromised the sterility of the finished drugs.
Essential Wellness Pharma is recalling TRIMIX #2 Injection vials because poor sterile production practices resulted in a lack of sterility assurance for the finished drugs.
Vaughan Foods is recalling whole cucumbers due to a potential Salmonella contamination risk. The product was distributed in six states.
Downing Labs, LLC is recalling Acetyl-L-Carnitine and L-Carnitine injectable vials due to a lack of assurance of sterility. The products were distributed nationwide and internationally.
Essential Wellness Pharma is recalling Acetylcysteine 10% Ophthalmic Solution due to poor sterile production practices that compromised sterility assurance.
Downing Labs, LLC is recalling 315 vials of Methylcobalamin Injection Buffered 5mg/mL due to a lack of assurance of sterility. The product was distributed nationwide and internationally.
Essential Wellness Pharma is recalling specific lots of Progesterone 100 mg/mL Ethyl Oleate Injection due to poor sterile production practices that compromise sterility assurance.
Hill-Rom is voluntarily recalling 12,251 Hill-Rom 100 Low Beds because patients were injured while exiting the beds at the lowest position setting.
US Compounding Inc is recalling 13,843 vials of Triamcinolone diacetate USP (40 mg/mL) nationwide due to deficient practices that may impact sterility assurance.
Downing Labs, LLC is recalling 16 vials of L-Tryptophan Injectable because the company cannot assure the product's sterility.
US Compounding Inc is recalling 105 syringes of Hyaluronic Acid/Lidocaine due to deficient practices that may impact sterility assurance.
Downing Labs is recalling 104 vials of EDTA Calcium Disodium Injectable because the company cannot assure the product's sterility.
Downing Labs, LLC is recalling 235 vials of Dexpanthenol Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide and internationally.
Downing Labs, LLC is recalling Thiotic Acid Injection because the company cannot ensure the product is sterile. The recall affects 7 vials distributed in the US and 17 other countries.
Grocery Delivery E-Services USA, Inc. is recalling cucumbers from Hello Fresh meal kits due to potential Salmonella contamination.
Essential Wellness Pharma is recalling Sermorelin 1000 mcg/mL / LIDO 0.2% Injection vials because poor sterile production practices resulted in a lack of sterility assurance.
Kanan Enterprises is recalling Sweet & Salty Mix products because they contain undeclared milk. The recall covers multiple package sizes sold under Choice, Speedy, and King's brands.
Downing Labs, LLC is recalling DMSO 99% Injection vials because the product lacks assurance of sterility. The recall affects 187 vials distributed in the US and internationally.
Essential Wellness Pharmacy is recalling Methylcobalamin 20 mg/mL prefilled syringes due to poor sterile production practices that compromised sterility assurance.
Downing Labs, LLC is recalling 171 vials of TNPRDC Injection because the company cannot assure the sterility of the product. The recall covers all lots distributed nationwide and internationally.
Essential Wellness Pharma is recalling TRIMIX SPECIAL Injection vials because poor sterile production practices created a lack of sterility assurance for the finished drugs.
Essential Wellness Pharma is recalling 17-Alpha Hydroxyprogesterone injections due to poor sterile production practices that compromised sterility assurance.
US Compounding Inc is recalling 22,627 vials of Methylprednisolone PF (80 mg/mL) because deficient practices may have impacted sterility assurance.
US Compounding Inc is recalling 2,524 vials of Testosterone cypionate, USP due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 2,984 bottles of compounded Dapiprazole ophthalmic vials nationwide due to deficient practices that may impact sterility assurance.