Severity 5 of 5

Critical recalls

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

What “critical” means here

Severity 5 (Critical) covers recalls where deaths or serious injuries have been reported, or where the agency itself classified the action as the highest severity (FDA Class I, NHTSA 'death/serious injury reported'). These are the recalls you should treat as urgent — stop using the product immediately and follow the agency's guidance. Common Severity-5 categories are pathogen-contaminated ready-to-eat foods (Listeria, E. coli O157, Salmonella), drug products with confirmed adverse-event reports, and vehicle defects with documented fatal crashes.

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.

4326–4350 of 7439

CriticalFDA (Food)·F-3105-2015·2015-09-16
Jeni's Cloverton Ice Cream Recalled for Listeria Contamination Risk
Jeni's Splendid Ice Creams LLC is recalling Cloverton ice cream products due to potential Listeria monocytogenes contamination.
Product
Cloverton Ice Cream Bucket, 351, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Cloverton Ice Cream Pint Case, 251, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Cloverton Ice Cream Pint, J
Category
Food
Distribution
18 states
CriticalFDA (Food)·F-3205-2015·2015-09-16
Jeni's Splendid Ice Creams Recalls Sweet Cream Ice Cream for Listeria Risk
Jeni's Splendid Ice Creams LLC is recalling Sweet Cream Ice Cream in pint, half-gallon, and case formats due to potential Listeria monocytogenes contamination.
Product
Sweet Cream Ice Cream Half Gallon Case, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, 4 half gallons per case, frozen. Sweet Cream Ice Cream Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen. Sweet
Category
Food
Distribution
18 states
CriticalFDA (Food)·F-3179-2015·2015-09-16
Jeni's Lemon & Blueberries Frozen Yogurt Recalled for Listeria Risk
Jeni's Splendid Ice Creams is recalling Lemon & Blueberries Frozen Yogurt in various sizes due to potential Listeria monocytogenes contamination.
Product
Lemon & Blueberries Frozen Yogurt Bucket, 314, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Lemon & Blueberries Frozen Yogurt Half Gallon Case, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, 4 half gallons per case, f
Category
Food
Distribution
18 states
CriticalFDA (Food)·F-3154-2015·2015-09-16
Jeni's Splendid Ice Creams Recalls Products Due to Listeria Risk
Jeni's Splendid Ice Creams LLC is recalling specific ice cream products because they may be contaminated with Listeria monocytogenes.
Product
Yellow Bucket, 813, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Yellow Pint Case, 713, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Yellow Pint, Jeni's Splendid Ice Creams, LLC, pint size,
Category
Food
Distribution
18 states
CriticalFDA (Food)·F-3151-2015·2015-09-16
Jeni's Wildberry Lavender Ice Cream Recalled for Listeria Risk
Jeni's Splendid Ice Creams is recalling Wildberry Lavender Ice Cream in gallon buckets and pints due to potential Listeria monocytogenes contamination.
Product
Wildberry Lavender Ice Cream Bucket, 327, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Wildberry Lavender Ice Cream Pint Case, 220, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Wildberry Lav
Category
Food
Distribution
18 states
CriticalFDA (Food)·F-3142-2015·2015-09-16
Jeni's Ice Cream Recalled for Potential Listeria Contamination
Jeni's Splendid Ice Creams is recalling Sweet Cream w/ Molasses & Peanuts ice cream due to potential Listeria monocytogenes contamination.
Product
Sweet Cream w/ Molasses & Peanuts Ice Cream Bucket, 352, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Sweet Cream w/ Molasses & Peanuts Ice Cream Half Gallon Case, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, 4 half
Category
Food
Distribution
18 states
CriticalFDA (Food)·F-3122-2015·2015-09-16
Jeni's Pistachio & Honey Ice Cream Recalled for Listeria Risk
Jeni's Splendid Ice Creams is recalling Pistachio & Honey Ice Cream in various sizes due to potential Listeria monocytogenes contamination.
Product
Pistachio & Honey Ice Cream Bucket, 319, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Pistachio & Honey Ice Cream Indie Case, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per case, frozen. Pistachio & Hon
Category
Food
Distribution
18 states
CriticalFDA (Food)·F-3143-2015·2015-09-16
Jeni's Sweet Potato Ice Cream Recalled for Listeria Risk
Jeni's Splendid Ice Creams is recalling Sweet Potato w/Torched Marshmallows ice cream due to potential Listeria monocytogenes contamination.
Product
Sweet Potato w/Torched Marshmallows Ice Cream Bucket, 333, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Sweet Potato w/Torched Marshmallows Ice Cream Pint Case, 233, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pint
Category
Food
Distribution
18 states
CriticalFDA (Food)·F-3225-2015·2015-09-16
Jeni's Blackout Terrine Slice Recalled for Listeria Contamination
Jeni's Splendid Ice Creams LLC is recalling Blackout Terrine Slices due to potential Listeria monocytogenes contamination. The product was distributed in 18 U.S. states.
Product
Blackout Terrine Slice, Jeni's Splendid Ice Creams, LLC, Slice, plastic bag, individually packed, frozen. Blackout Terrine Slice Case, Jeni's Splendid Ice Creams, LLC, Slice, plastic bag, 12 slices per case, frozen.
Category
Food
Distribution
18 states
CriticalFDA (Food)·F-3104-2015·2015-09-16
Jeni's Cinderella Pumpkin Ice Cream Recalled for Listeria Risk
Jeni's Splendid Ice Creams LLC is recalling Cinderella Pumpkin Ice Cream products due to potential Listeria monocytogenes contamination.
Product
Cinderella Pumpkin Ice Cream Bucket , 371, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Cinderella Pumpkin Ice Cream Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen. Cinder
Category
Food
Distribution
18 states
CriticalFDA (Food)·F-3184-2015·2015-09-16
Jeni's Red Raspberry Frozen Yogurt Recalled for Listeria Risk
Jeni's Splendid Ice Creams is recalling Red Raspberry Frozen Yogurt products due to potential Listeria monocytogenes contamination.
Product
Red Raspberry Frozen Yogurt Bucket, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Red Raspberry Frozen Yogurt Poppin' J Case, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, 25 containers per case, frozen. Red Raspberry Fr
Category
Food
Distribution
18 states
CriticalFDA (Food)·F-3117-2015·2015-09-16
Jeni's Splendid Ice Creams Recalls Vanilla Bean Ice Cream Due to Listeria Risk
Jeni's Splendid Ice Creams LLC is recalling multiple sizes of Ndali Estate Vanilla Bean Ice Cream because the product may be contaminated with Listeria monocytogenes.
Product
Ndali Estate Vanilla Bean Ice Cream Bucket, 326, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Ndali Estate Vanilla Bean Ice Cream Indie Case, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per case, frozen.
Category
Food
Distribution
18 states
CriticalFDA (Food)·F-3156-2015·2015-09-16
Jeni's Askinosie Dark Milk Chocolate Ice Cream Recalled for Listeria Risk
Jeni's Splendid Ice Creams is recalling Askinosie Dark Milk Chocolate Ice Cream in pint and 3-gallon sizes due to potential Listeria monocytogenes contamination.
Product
Askinosie Dark Milk Chocolate Ice Cream Bucket, 353, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Askinosie Dark Milk Chocolate Ice Cream Pint Case, 213, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case,
Category
Food
Distribution
18 states
CriticalFDA (Food)·F-3097-2015·2015-09-16
Jeni's Brown Ice Cream Recalled for Listeria Monocytogenes Contamination
Jeni's Splendid Ice Creams LLC is recalling Brown Ice Cream products due to potential Listeria monocytogenes contamination. The recall covers 3-gallon buckets and pint containers distributed nationally.
Product
Brown Ice Cream Bucket, 803, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Brown Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. Brown Ice Cream Pint Case, 703, Jeni's Spl
Category
Food
Distribution
18 states
CriticalFDA (Food)·F-3190-2015·2015-09-16
Jeni's Sorbet Recalled for Potential Listeria Contamination
Jeni's Splendid Ice Creams is recalling Wheatgrass, Pear, & Vinho Verde Sorbet due to potential Listeria monocytogenes contamination.
Product
Wheatgrass, Pear, & Vinho Verde Sorbet Bucket, 808, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Wheatgrass, Pear, & Vinho Verde Sorbet Pint Case, 708, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, fr
Category
Food
Distribution
18 states
CriticalFDA (Food)·F-3186-2015·2015-09-16
Jeni's Watermelon Buttermilk Frozen Yogurt Recalled for Listeria Risk
Jeni's Splendid Ice Creams is recalling Watermelon Buttermilk Frozen Yogurt products due to potential Listeria monocytogenes contamination.
Product
Watermelon Buttermilk Frozen Yogurt Bucket, 817, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Watermelon Buttermilk Frozen Yogurt Pint Case, 717, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen
Category
Food
Distribution
18 states
CriticalFDA (Food)·F-3149-2015·2015-09-16
Jeni's White Chocolate Coconut Ice Cream Recalled for Listeria Risk
Jeni's Splendid Ice Creams is recalling White Chocolate Coconut ice cream in pints and 3-gallon buckets due to potential Listeria monocytogenes contamination.
Product
White Chocolate Coconut Bucket, 819, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. White Chocolate Coconut Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Category
Food
Distribution
18 states
CriticalFDA (Food)·F-3196-2015·2015-09-16
Jeni's Dark Chocolate Hazelnut Macaroon Sandwiches Recalled for Listeria Risk
Jeni's Splendid Ice Creams is recalling Dark Chocolate Hazelnut Macaroon Sandwiches due to potential Listeria monocytogenes contamination.
Product
Dark Chocolate Hazelnut Macaroon Sandwich Case, 502, Jeni's Splendid Ice Creams, LLC, 6.2oz sandwich, paper box, 14 boxes per case, frozen. Dark Chocolate Hazelnut Macaroon Sandwich, Jeni's Splendid Ice Creams, LLC, 6.2oz sandwich, paper box, individually packed, frozen. Mi
Category
Food
Distribution
18 states
CriticalFDA (Food)·F-3063-2015·2015-09-09
Mahina Mele Farm Recalls Chocolate Mac Nut Butter Due to Salmonella
Mahina Mele Farm is recalling Baby Bruddah's Chocolate Mac Nut Buttah because an ingredient sample tested positive for Salmonella.
Product
Baby Bruddah's Chocolate Mac Nut Buttah. 12 oz. container, UPC 735182242040 Mahina Mele Farm, Captain Cook, HI 96704
Category
Food
Distribution
10 states
CriticalFDA (Food)·F-3062-2015·2015-09-09
Mahina Mele Farm Recalls Mac Nut Butter Due to Salmonella
Mahina Mele Farm is recalling Baby Bruddah's Mac Nut Buttah because an ingredient sample tested positive for Salmonella.
Product
Baby Bruddah's Mac Nut Buttah. 12 oz. container, UPC 753182242019 Mahina Mele Farm, Captain Cook, HI 96704
Category
Food
Distribution
10 states
CriticalFDA (Food)·F-3061-2015·2015-09-09
Mahina Mele Farm Recalls Macadamia Nuts Due to Salmonella
Mahina Mele Farm is recalling Izzie Macs! Macadamia Nuts because an inspection sample tested positive for Salmonella.
Product
Izzie Macs! Macadamia Nuts; salted and unsalted pieces. Certified Organic Macadamia Nuts, 100% Big Island Grown. A Raw Food. sold in 5 lb. bag; Mahina Mele Farm, Captain Cook, HI 96704
Category
Food
Distribution
10 states
CriticalFDA (Food)·F-3060-2015·2015-09-09
Mahina Mele Farm Recalls Macadamia Nuts Due to Salmonella Risk
Mahina Mele Farm is recalling Izzie Macs! Macadamia Nuts because an inspection sample tested positive for Salmonella. Consumers should stop eating the product and return it to the store.
Product
Izzie Macs! Macadamia Nuts; Unsalted. Certified Organic Macadamia Nuts, 100% Big Island Grown. A Raw Food. sold in 6 oz. and 16 oz sizes. 6 oz, UPC 689076793575; 16 oz. UPC 689076792776 Mahina Mele Farm, Captain Cook, HI 96704
Category
Food
Distribution
10 states
CriticalFDA (Food)·F-3059-2015·2015-09-09
Mahina Mele Farm Recalls Salted Macadamia Nuts Due to Salmonella
Mahina Mele Farm is recalling salted macadamia nuts after an FDA sample tested positive for Salmonella. Consumers should stop eating the product and return it to the store.
Product
Izzie Macs! Macadamia Nuts; Salted. Certified Organic Macadamia Nuts, 100% Big Island Grown. A Raw Food. sold in 6 oz. and 16 oz sizes. 6 oz, UPC 689076792677; 16 oz. UPC 689076792974 Mahina Mele Farm, Captain Cook, HI 96704
Category
Food
Distribution
10 states
CriticalFDA (Food)·F-3076-2015·2015-09-09
Good Seed Recalls Mung Bean Sprouts Due to Listeria Risk
Good Seed, Inc. is voluntarily recalling mung bean sprouts due to potential Listeria monocytogenes contamination. The products were distributed to retail stores in Virginia, Maryland, and New Jersey.
Product
Mung Bean sprouts, 1, 2 & 10-lb clear plastic bags labeled GOODSEED Mung Bean Sprouts, Keep Refrigerated
Category
Food
Distribution
3 states
CriticalFDA (Drugs)·D-1357-2015·2015-09-02
PharMEDium Recalls Heparin Sodium Injection Bags Due to Particulate Matter
PharMEDium Services, LLC is recalling 240 bags of Heparin Sodium Injection USP 25,000 Units in 250 mL bags due to the presence of particulate matter.
Product
HEPARIN Sodium Injection USP 25,000 USP Units added to 250 mL 5% Dextrose Injection USP (100 units per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K0419, NDC# 61553-419-02.
Category
Drug
Distribution
Distributed nationwide