Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

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.

7076–7100 of 29119

SevereFDA (Drugs)·D-0414-2022·2022-02-02
Eye Drops Recalled for Lack of Sterility Assurance by Edge Pharma
Edge Pharma is recalling a multi-ingredient sterile ophthalmic solution nationwide due to lack of assured sterility. The product is used for topical eye application.
Product
Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution, 10%/1%/0.3%/0.125%, 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1270-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0552-2022·2022-02-02
Chopped Sunflower Bacon Salad Recall for Listeria Contamination
Fresh Express Inc is recalling Chopped Sunflower Bacon salad products (13.8oz and 22.3oz packages) due to potential Listeria monocytogenes contamination. The recall affects domestic and Canadian distributors across multiple states.
Product
"Chopped Sunflower Bacon" (salad product) packed in 13.8oz. and 22.3oz. packages
Category
Food
Distribution
20 states
SevereFDA (Food)·F-0565-2022·2022-02-02
Fresh Express Juicing Greens salad recalled for potential Listeria contamination
Fresh Express is recalling Juicing Greens salad products (11oz packages, codes Z324-Z350) due to potential Listeria monocytogenes contamination. The products were distributed to retailers in 20 U.S. states and Canada.
Product
"Juicing Greens" (salad product) packed in 11oz. packages
Category
Food
Distribution
20 states
SevereFDA (Food)·F-0588-2022·2022-02-02
Fresh Express Pear Gorgonzola Salad Recalled for Listeria Risk
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.
Product
"Pear Gorgonzola" (salad product) packed in 6.7oz. packages
Category
Food
Distribution
20 states
SevereFDA (Food)·F-0523-2022·2022-02-02
5-Lettuce Mix Salad Recalled for Potential Listeria Contamination
Fresh Express's 5-Lettuce Mix salad (6oz packages, code Z324-Z350) is recalled due to potential Listeria monocytogenes contamination. The product was distributed to over 110 domestic and 3 international distributors.
Product
"5- Lettuce Mix" (salad product) packed in 6oz. packages
Category
Food
Distribution
20 states
SevereFDA (Drugs)·D-0426-2022·2022-02-02
Vancomycin HCl Injection Recalled for Sterility Assurance Issues
Edge Pharma LLC is recalling Vancomycin HCl in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. The affected product is a 500 mL pre-filled bag for IV injection.
Product
Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1458-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0567-2022·2022-02-02
Fresh Express Leafy Romaine Salad Recalled for Listeria Contamination Risk
Fresh Express Inc is recalling Leafy Romaine salad in 9oz. and 10oz. packages due to potential Listeria monocytogenes contamination. The product was distributed to multiple states and Canada.
Product
"Leafy Romaine" (salad product) packed in 9oz. and 10oz. packages
Category
Food
Distribution
20 states
SevereFDA (Drugs)·D-0399-2022·2022-02-02
Dexamethasone Sodium Phosphate Otic Injection Syringes Recalled for Lack of Sterility Assurance
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.
Product
Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL (24mg/mL), 0.8 mL per syringe Single Use Syringe For Otic Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0848-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0572-2022·2022-02-02
Fresh Express Organic Baby Arugula & Spinach Recall for Listeria Contamination
Fresh Express Inc is recalling approximately 12,107 cases of Organic Baby Arugula & Baby Spinach salad mix due to potential contamination with Listeria monocytogenes. The affected product was distributed across multiple states and Canada.
Product
"Organic Baby Arugula & Baby Spinach" (salad product) packed in 5oz. packages
Category
Food
Distribution
20 states
SevereFDA (Food)·F-0535-2022·2022-02-02
Caesar Lite Salad Recalled for Potential Listeria Contamination
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.
Product
"Caesar Lite" (salad product) packed in 9.8oz. packages
Category
Food
Distribution
20 states
SevereFDA (Food)·F-0576-2022·2022-02-02
Fresh Express Organic Baby Spinach & Kale Mix Recall: Listeria Risk
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.
Product
"Organic Baby Spinach & Baby Kale Mix" (salad product) packed in 5oz. packages
Category
Food
Distribution
20 states
SevereFDA (Food)·F-0527-2022·2022-02-02
Fresh Express Avocado Ranch Salad Recalled for Listeria Risk
Fresh Express Inc is recalling Avocado Ranch salad products in 9.7oz and 12.8oz packages due to potential Listeria monocytogenes contamination. The products were distributed to wholesalers across 20 U.S. states and Canada.
Product
"Avocado Ranch" (salad product) packed in 9.7oz. and 12.8oz. packages
Category
Food
Distribution
20 states
SevereFDA (Food)·F-0580-2022·2022-02-02
Fresh Express Organic Half & Half Salad Recalled for Listeria Risk
Fresh Express Inc is recalling Organic Half & Half salad in 5oz. and 16oz. packages due to potential Listeria monocytogenes contamination. The product was distributed across the United States and Canada.
Product
"Organic Half & Half" (salad product) packed in 5oz. and 16oz. packages
Category
Food
Distribution
20 states
SevereFDA (Food)·F-0534-2022·2022-02-02
Fresh Express Caesar Bacon Salad Recalled for Listeria Risk
Fresh Express Inc is recalling Caesar Bacon salad products (9.9oz., 10.3oz., and 14.6oz. packages) due to potential Listeria monocytogenes contamination. The affected products were distributed to domestic and Canadian wholesalers.
Product
"Caesar Bacon" (salad product) packed in 9.9oz., 10.3oz., and 14.6oz. packages
Category
Food
Distribution
20 states
SevereFDA (Food)·F-0584-2022·2022-02-02
Organic Spring Mix Salad Recalled Due to Listeria Contamination Risk
Fresh Express Inc is recalling Organic Spring Mix salad in 5oz., 10oz., and 16oz. packages due to potential Listeria monocytogenes contamination. Affected products were distributed to retailers and distributors across 20 US states and Canada.
Product
"Organic Spring Mix" (salad product) packed in 5oz., 10oz., and 16oz. packages
Category
Food
Distribution
20 states
SevereFDA (Food)·F-0531-2022·2022-02-02
Fresh Express Bacon & Blue Salad Recalled for Listeria Risk
Fresh Express Inc is recalling "Bacon & Blue" salad products (10.8 oz and 10.9 oz packages) distributed across 20 U.S. states and Canada due to potential Listeria monocytogenes contamination.
Product
"Bacon & Blue" (salad product) packed in 10.8oz. and 10.9oz. packages
Category
Food
Distribution
20 states
SevereFDA (Food)·F-0554-2022·2022-02-02
Fresh Express Coleslaw Recalled for Potential Listeria Contamination
Fresh Express Inc is recalling coleslaw products in 14oz., 16oz., and 24oz. packages due to potential contamination with Listeria monocytogenes. The recall affects 46,083 cases distributed across 20 U.S. states and Canada.
Product
"Coleslaw" (salad product) packed in 14oz., 16oz, and 24oz. packages
Category
Food
Distribution
20 states
SevereFDA (Food)·F-0591-2022·2022-02-02
Roma Sliced Salad Recalled for Potential Listeria Contamination
Fresh Express Inc is recalling Roma Sliced salad products in 1.5lb. packages due to potential contamination with Listeria monocytogenes. The affected products were distributed to domestic and Canadian distributors.
Product
"Roma Sliced" (salad product) packed in 1.5lb. packages
Category
Food
Distribution
20 states
SevereFDA (Food)·F-0570-2022·2022-02-02
Old Fashion Coleslaw Recalled for Listeria Contamination Risk
Fresh Express Inc is recalling Old Fashion Coleslaw (14oz packages) due to potential Listeria monocytogenes contamination across 20 U.S. states and Canada.
Product
"Old Fashion Coleslaw" (salad product) packed in 14oz. packages
Category
Food
Distribution
20 states
SevereFDA (Food)·F-0604-2022·2022-02-02
Sweet Dijon Onion Salad Recalled for Listeria Contamination Risk
Fresh Express Inc is recalling Sweet Dijon Onion salad products in 7.6oz. packages due to potential Listeria monocytogenes contamination. The product was distributed to retailers across 20 US states and Canada.
Product
"Sweet Dijon Onion" (salad product) packed in 7.6oz. packages
Category
Food
Distribution
20 states
SevereFDA (Food)·F-0622-2022·2022-02-02
NutriCrafters MCT Powder Recalled Due to Supplier Recall
NutriCrafters LLC is recalling Nutricrafters MCT Instant Coconut Milk Mixer (1 lb. bottles) because the medium chain triglyceride powder was repacked and distributed from a supplier product that is itself under recall.
Product
Nutricrafters MCT - Instant coconut milk mixer; 1 lb. (454 grams) Ingredients: Medium chain triglycerides, tapioca starch. Allergy information : contains oils from tree nuts (coconut) Suggested use: Stir into drinks or spoon over foods. Start with 1 teaspoon, preferably w
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0543-2022·2022-02-02
Chopped Cherry Almond Gorgonzola Salad Recalled for Listeria Risk
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.
Product
"Chopped Cherry Almond Gorgonzola" (salad product) packed in 13.7oz. packages
Category
Food
Distribution
20 states
SevereFDA (Drugs)·D-0416-2022·2022-02-02
Edge Pharma Phenylephrine HCl IV Injection Sterility Assurance Recall
Edge Pharma is recalling Phenylephrine HCl 1mg/10mL single-use syringes for IV injection due to lack of assurance of sterility. The recall affects 6,535 vials distributed nationwide.
Product
Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446 NDC 05446-1544-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0537-2022·2022-02-02
Chef Salad Bowl Products Recalled for Potential Listeria Contamination
Fresh Express Inc is recalling Chef Salad Bowl products due to potential contamination with Listeria monocytogenes. The recall affects 6.2oz packages distributed to domestic and Canadian distributors.
Product
"Chef Salad Bowl" (salad product) packed in 6.2oz. packages
Category
Food
Distribution
20 states
SevereFDA (Drugs)·D-0419-2022·2022-02-02
Edge Pharma Phenylephrine/Lidocaine Ophthalmic Solution Sterility Recall
Edge Pharma is recalling Phenylephrine HCl/Lidocaine sterile ophthalmic solution for injection due to lack of assurance of sterility. The recalled product consists of 2,750 single-use syringes distributed nationwide.
Product
Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free, 1.5%/1%, 0.8mL per syringe, Single Use Syringe For Intraocular Injection, Edge Pharma LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1118-01
Category
Drug
Distribution
Distributed nationwide