Severity 4 of 5
Illness, injury, or structural failure has been reported. 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.
Fresh Express Inc is recalling Asian Avocado salad products in 9.7oz packages due to potential contamination with Listeria monocytogenes. The recall affects approximately 1,053 cases distributed across multiple U.S. states and Canada.
Edge Pharma, LLC is recalling Phenylephrine HCl 0.5 mg/5mL single-use syringes for intravenous injection nationwide due to lack of assurance of sterility. The affected product was distributed between September 2021 and January 2022.
Edge Pharma is recalling Mitomycin-C 40 mg/40 mL single-dose syringes (NDC 05446-1416-01) nationwide due to lack of assurance of sterility. Approximately 860 syringes are affected.
Edge Pharma is recalling Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection due to lack of assurance of sterility. The recall affects 2,568 single-use syringes distributed nationwide.
Fresh Express Inc is recalling Fancy Greens salad in 7oz packages due to potential Listeria monocytogenes contamination. The affected products were distributed to retailers across 20 U.S. states and Canada.
Edge Pharma is recalling Mitomycin-C Sterile Ophthalmic Solution because the manufacturer cannot assure that the product is sterile. The recall affects 163 syringes distributed nationwide.
Viona Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release 750 mg tablets due to detection of N-Nitrosodimethylamine (NDMA) at levels exceeding the acceptable daily intake limit. The contamination resulted from manufacturing deviations.
Edge Pharma LLC is recalling Dexamethasone sodium phosphate sterile otic solution for injection syringes (NDC 05446-0848-01) due to lack of assurance of sterility. Approximately 323 syringes were distributed nationwide.
Fresh Express Inc is recalling 12,835 cases of Caesar Lite salad product (9.8 oz packages) due to potential contamination with Listeria monocytogenes. The affected product was distributed to domestic and Canadian distributors.
Fresh Express Inc is recalling Italian salad in 9oz. packages due to potential Listeria monocytogenes contamination. The affected product was distributed to retailers across the United States and Canada.
Edge Pharma is recalling Edetate Disodium (EDTA) 3% Sterile Ophthalmic Solution due to lack of assurance of sterility. The product is a single-dose eye drop used for topical ophthalmic use.
Fresh Express Inc has recalled "Spinach" salad products in 8oz., 10oz., and 16oz. packages due to potential contamination with Listeria monocytogenes. The recall affects 130,592 cases distributed to domestic and foreign distributors.
Fresh Express Inc is recalling Crisp Greens salad in 12oz. packages due to potential contamination with Listeria monocytogenes. The recall affects products distributed to domestic and Canadian distributors across 20 U.S. states.
Fresh Express Inc is recalling shredded lettuce products in multiple package sizes due to potential Listeria monocytogenes contamination. The recall affects approximately 211,228 cases distributed across 20 U.S. states and Canada.
Fresh Express Inc is recalling Pear Gorgonzola salad in 6.7 oz. packages due to potential contamination with Listeria monocytogenes. The recall affects products distributed to multiple domestic and Canadian distributors.
Fresh Express Inc is recalling "Organic Baby Spinach & Baby Kale Mix" salad in 5oz packages due to potential contamination with Listeria monocytogenes. The affected product was distributed to over 110 domestic distributors across multiple states and Canada.
Edge Pharma is recalling a sterile ophthalmic injectable solution because the manufacturer cannot guarantee that the product remains sterile. The recall affects approximately 1,202 syringes distributed nationwide.
Fresh Express Inc is recalling Sweet Lettuce salad products in 5oz packages due to potential contamination with Listeria monocytogenes. The affected products were distributed to wholesalers across the United States and Canada.
Edge Pharma is recalling phenylephrine injection (20 mg/250 mL) because the manufacturer cannot assure the product maintains sterility. The recall affects 3,930 bags distributed nationwide.
Fresh Express Inc is recalling Green & Crisp salad in 11oz packages due to potential Listeria monocytogenes contamination. The recall affects 26,695 cases distributed across multiple US states and Canada.
Edge Pharma, LLC is recalling ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate) IV bags nationwide due to lack of assurance of sterility. The affected product is a prescription intravenous medication supplied in 300 ml bags.
Fresh Express Inc is recalling Chopped Cherry Almond Gorgonzola salad products (13.7 oz packages, codes Z324-Z350) due to potential Listeria monocytogenes contamination. The salad was distributed across 20 U.S. states and Canada.
A salad product from Fresh Express (Veggie Lover's, 31,931 cases) sold across the U.S. and Canada is being recalled due to potential contamination with Listeria monocytogenes.
Fresh Express Inc is recalling Organic Baby Arugula in 5oz. and 16oz. packages due to potential contamination with Listeria monocytogenes. The product was distributed across multiple U.S. states and Canada.
Fresh Express Inc is recalling approximately 27,047 cases of Chopped Sweet Kale salad due to potential contamination with Listeria monocytogenes. The affected 10.9oz packages were distributed across multiple states and Canada.