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 MIC Injection vials because poor production practices may have compromised the sterility of the finished drugs.
US Compounding Inc is recalling 12,191 syringes of ePHEDrine Sulfate PF (50 mg/10 mL) nationwide due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 562 vials of Zinc Sulfate 1 mg/mL due to deficient practices that may impact sterility assurance.
Del Monte is recalling specific lots of Strawberry Blueberry Yogurt Parfait because they may contain undeclared almonds, posing a risk to individuals with allergies.
A & S Food Trading Inc. is recalling Hua Zhi Ying Gourd Candy because it contains undeclared sulfites and FD&C Blue #1.
Essential Wellness Pharma is recalling specific lots of Cyclosporin 0.1% Opth Solution because poor sterile production practices created a lack of sterility assurance.
US Compounding Inc is recalling 14,325 syringes of Glycopyrrolate USP due to deficient practices that may impact sterility assurance.
Essential Wellness Pharmacy is recalling Methylcobalamin 30 mg/mL prefilled syringes due to poor sterile production practices that compromise sterility assurance.
Front Row Produce LLC is recalling raw cucumbers in Missouri due to potential Salmonella contamination.
Downing Labs, LLC is recalling 286 vials of Calcium Gluconate Injection 10% because the company cannot ensure the product is sterile.
Downing Labs, LLC is recalling 289 vials of Magnesium Chloride Hexahydrate Injection due to a lack of assurance of sterility. The product was distributed nationwide and internationally.
Downing Labs, LLC is recalling Pyridoxine Injection, 100 mg/mL, 30mL vials due to a lack of assurance of sterility. The recall affects 280 vials distributed nationwide and internationally.
Essential Wellness Pharma is recalling 17-Alpha Hydroxyprogesterone injections due to poor sterile production practices that compromise sterility assurance.
Essential Wellness Pharma is recalling 76 vials of LIPO B Injection because poor production practices created a lack of sterility assurance.
US Compounding Inc is recalling 589 vials of Brompheniramine Maleate due to deficient practices that may impact sterility assurance.
Downing Labs, LLC is recalling Co-Enzyme Q-10 Injectable vials because the product lacks assurance of sterility. The recall covers all lots distributed in the US and internationally.
US Compounding Inc is recalling 11 vials of Phenylephrine due to deficient practices that may impact sterility assurance.
Downing Labs, LLC is recalling 186 vials of Methylcobalamin Buffered Injectable because the company cannot ensure the product is sterile.
Downing Labs, LLC is recalling Cyanocobalamin Buffered Injectable 3mg/mL vials because the company cannot ensure the product is sterile.
Downing Labs, LLC is recalling MIC w/Methyl B-12 Preserved Injection vials because the company cannot assure the sterility of the product. The recall affects 49 vials distributed nationwide and internationally.
Essential Wellness Pharmacy is recalling Testosterone Cypionate 50 mg/mL injections due to poor sterile production practices that compromise sterility assurance.
Downing Labs, LLC is recalling 467 vials of L-Glutathione Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide and internationally.
US Compounding Inc is recalling 711 fentanyl syringes nationwide because deficient practices may have impacted sterility assurance.
Fresenius Medical Care is recalling 348 dry acid dissolution units because defective motors may generate smoke or cause fire.
US Compounding Inc is recalling 1,386 vials of Testosterone EO-Pro-Cyp 220 due to deficient practices that may impact sterility assurance.