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.

3076–3100 of 7439

CriticalFDA (Drugs)·D-0863-2017·2017-05-31
Hyland's Baby Teething Tablets Recalled for Inconsistent Belladonna Alkaloid Levels
Standard Homeopathic Company is recalling Hyland's Baby Teething Tablets because FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from label claims.
Product
Hyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated)] Quick-Dissolving Tablets, packaged in a) 40-count bottles (NDC 54973-3127-3) (UPC 3 54973 31273 9); b) 135-count bo
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0862-2017·2017-05-31
Hospira Recalls Dextrose Injection Syringes Due to Human Hair Particulate
Hospira is recalling 71,550 syringes of Infant 25% Dextrose Injection because human hair was found in an internal sample. The product was distributed nationwide and in Puerto Rico.
Product
DEXTROSE — DEXTROSE (DEXTROSE MONOHYDRATE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Food)·F-2268-2017·2017-05-31
Tropic Fish Hawaii Recalls Frozen Yellowfin Tuna Cubes for Hepatitis A
Tropic Fish Hawaii is recalling 150 cases of Reel Fresh Yellowfin Tuna Hilo Cubes because the product tested positive for hepatitis A. The affected tuna was distributed on the Island of Oahu.
Product
Yellowfin Tuna Hilo Cubes, Random cut. 15 lb. cases. (1 x 15 lb. bags per case) Brand name: Reel Fresh UPC: 664183001454 Ingredients: Frozen tuna and carbon monoxide (to promote color retention). Product of Indonesia, Wild Caught
Category
Food
Distribution
0 states
CriticalFDA (Food)·F-2269-2017·2017-05-31
Nutty INFUSIONS Ginger Wasabi Cashew Butter Recalled for Listeria Contamination
Huson Valley Farms is recalling Nutty INFUSIONS Ginger Wasabi Cashew Butter due to Listeria monocytogenes contamination. The product was distributed nationwide through a wholesale in Illinois.
Product
Nutty INFUSIONS Ginger Wasabi Cashew Butter, NET WT. 10 OZ (284 g)
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0867-2017·2017-05-31
Envy Me Recalls LaBri's Body Health Atomic Due to Undeclared Sibutramine
Envy Me is recalling LaBri's Body Health Atomic capsules because the product contains undeclared Sibutramine and was marketed without an approved NDA/ANDA.
Product
LaBri's Body Health Atomic, 60 capsules
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Food)·F-2245-2017·2017-05-31
Phoenix Food Recalls Dip Trio Mix for Possible Salmonella Contamination
Phoenix Food, LLC is recalling 11,936 boxes of Dip Trio Mix due to possible Salmonella contamination. The product was distributed across 25 U.S. states and Canada.
Product
Dip Trio Mix Homemade Gourmet Dip Mix Net Wt. 2.9 oz. Distributed by: Phoenix Food, LLC. Canton, TX 75103 www.homemadegourmet.com
Category
Food
Distribution
24 states
CriticalFDA (Food)·F-2249-2017·2017-05-31
Herbal Tea Variety Recalled for Potential Clostridium botulinum Contamination
U S Deer Antlers Export & Import is recalling Herbal Tea Variety pouches due to potential Clostridium botulinum contamination.
Product
Herbal Tea Variety 120 ml/pouch, 40 pouches/case
Category
Food
Distribution
14 states
CriticalFDA (Food)·F-2266-2017·2017-05-31
Huson Valley Farms Recalls Cashew Butter for Listeria Contamination
Huson Valley Farms is recalling 5,022 jars of Nutty INFUSIONS Roasted Cashew Butter due to Listeria monocytogenes contamination. The product was distributed nationwide through a wholesale in Illinois.
Product
Nutty INFUSIONS Roasted Cashew Butter, NET WT. 10 OZ (284 g)
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-2246-2017·2017-05-31
Chef Luca's Frozen Lasagna Recalled for Undeclared Eggs
Italian Gluten Free Foods CL is recalling Chef Luca's Lasagna Al Forno due to undeclared eggs. The product was distributed in nine states.
Product
Chef Luca's Italian Gluten Free Foods Lasagna Al Forno Baked Cheese Lasagna, 15 oz . frozen UPC Code: 85573103116
Category
Food
Distribution
7 states
CriticalFDA (Food)·F-2241-2017·2017-05-31
Starbucks Slow Roasted Ham & Swiss Sandwich Recalled for Listeria
SK Food Group is recalling Starbucks Slow Roasted Ham & Swiss Breakfast Sandwiches due to potential Listeria monocytogenes contamination.
Product
Slow Roasted Ham & Swiss Breakfast Sandwich, Fully Cooked/Keep Frozen/Perishable Net Wt 5.6 oz (159 g) MANUFACTURED EXCLUSIVELY FOR STARBUCKS COFFEE COMPANY SEATTLE, WA 98134 UPC 7 62111 10495 1
Category
Food
Distribution
4 states
CriticalFDA (Food)·F-2217-2017·2017-05-24
Whole Foods Recalls Holiday Cookies Due to Undeclared Egg
Whole Foods Market is recalling 9,936 decorated holiday cookies sold in the Bay Area because they contain an undeclared egg allergen.
Product
Decorated (sugared) holiday cookies sold in the shape of purple eggs, pink bunnies or yellow chicks. These cookies were sold in the self service cookie display.
Category
Food
Distribution
0 states
CriticalFDA (Food)·F-2235-2017·2017-05-24
Del Mar IQF Chopped Spinach Recalled for Listeria Monocytogenes
Del Mar Food Products Corp. is recalling IQF Chopped Spinach after a customer reported a positive Listeria Monocytogenes test result.
Product
I.Q.F Chopped Spinach, Del Mar Foods Product Corp; 35 lb. Net Weight. brown case fiber with polyliner Del Mar Food Products; Watsonville, CA 95077
Category
Food
Distribution
2 states
CriticalFDA (Food)·F-2240-2017·2017-05-24
Wegmans Potato Salad Recalled for Undeclared Egg Allergen
ASK Foods Inc is recalling Wegmans Family Pack Potato Salad because the containers were labeled with a statement from a different product, failing to declare egg.
Product
Wegmans Wegmans Family Pack Potato Salad, Net Wt. 48 OZ; Ingredients: Pasta Shells***Water, Cucumbers, Feta Cheese...ect; Allergens: Contains Milk and Wheat; Distributed By: Wegmans Food Markets, Inc., Rochester, NY 14603; Sell By: 5/7/17 3379-4; UPC: 7789024678
Category
Food
Distribution
3 states
CriticalFDA (Devices)·Z-2038-2017·2017-05-24
Abbott NC Traveler RX Coronary Dilatation Catheter Recall for Balloon Sheath Issues
Abbott Vascular is recalling NC Traveler RX Coronary Dilatation Catheters because the protective balloon sheath may be difficult to remove, potentially affecting balloon inflation or deflation.
Product
NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1013154-08, 1013154-12, 1013154-15, 1013154-20, 1013155-08, 1013155-12 1013155-15, 1013155-20, 1013156-12, 1013156-15, 1013157-08, 1013157-1
Category
Medical Device
Distribution
0 states
CriticalCPSC·17159·2017-05-19
Blomberg and Summit Electric Ranges Recalled for Electrocution Hazard
Arçelik A.S. is recalling about 6,300 Blomberg and Summit electric ranges because they can become energized, posing shock and electrocution risks.
Product
Blomberg and Summit electric ranges
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Food)·F-2215-2017·2017-05-17
Frito-Lay Recalls Lays Kettle Cooked Multipacks Due to Salmonella Risk
Frito-Lay is recalling 1,196,880 units of Lays Kettle Cooked Multipack Trays nationwide due to the potential presence of Salmonella.
Product
30 count Lays Kettle Cooked Multipack Tray 41.25 oz. packaged in flexible plastic
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-2213-2017·2017-05-17
Frito-Lay Bold Mix Sack Recalled for Potential Salmonella Presence
Frito-Lay is recalling 20-count Bold Mix Sacks nationwide due to the potential presence of Salmonella.
Product
20 count Frito-Lay Bold Mix Sack 18.4 oz. packaged in flexible plastic
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-2216-2017·2017-05-17
Frito-Lay Recalls Miss Vickies Multipacks Due to Potential Salmonella
Frito-Lay is recalling 32-count Miss Vickies Multipacks due to potential Salmonella contamination. The recall covers units distributed nationwide and in Puerto Rico.
Product
32 count Miss Vickies Multipack Box 44 oz. packaged in flexible plastic
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-2173-2017·2017-05-10
Killer Brownie German Chocolate Brownies Recalled for Undeclared Peanuts
Killer Brownie Distributing LLC is recalling German Chocolate Killer Brownies due to undeclared peanuts, a potential allergen hazard.
Product
GERMAN CHOCOLATE KB KILLER BROWNIE¿ 3x35 CT NET WT 36 LBS (16.33 kg) CONTAINS: Milk, Nuts: Pecans, Soy, Wheat UPC 10858061005321. Item #483-2016
Category
Food
Distribution
5 states
CriticalFDA (Drugs)·D-0690-2017·2017-05-10
EpiPen Auto-Injectors Recalled for Defective Delivery System
Meridian Medical Technologies is recalling EpiPen auto-injectors because the delivery system may fail to activate, preventing patients from receiving epinephrine.
Product
EPIPEN — EPIPEN (EPINEPHRINE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Food)·F-2175-2017·2017-05-10
Killer Brownie Recalls Brownies for Undeclared Peanuts
Killer Brownie Distributing LLC is recalling Original KB Killer Brownies due to undeclared peanuts. The product was distributed to Minnesota, New York, Ohio, Pennsylvania, and Wisconsin.
Product
ORIGINAL KB KILLER BROWNIE¿ 3x35 CT NET WT 36 LBS (16.33 kg) CONTAINS: Milk, Nuts: Pecans, Soy, Wheat UPC 10858061005031. Item #48-2016
Category
Food
Distribution
5 states
CriticalFDA (Food)·F-2167-2017·2017-05-10
FDA Recalls Life Rising SHT Chest Relief Due to Lead Contamination
Ton Shen Health Inc is recalling Life Rising Formulas SHT Chest Relief capsules because the product is potentially contaminated with lead. The recall affects 37 bottles distributed in Illinois.
Product
Life Rising Formulas SHT Chest Relief, 54 Capsules; Manufactured for: Nature's Health (USA) Chicago, IL 60616
Category
Food
Distribution
1 state
CriticalFDA (Food)·F-2180-2017·2017-05-10
Aroma Imports Recalls Nabelsi Thyme Due to Elevated Lead Levels
Aroma Imports Inc is recalling Nabelsi Thyme (Zatar) in 450g and 4.5kg packages due to elevated lead levels. The product was distributed in five states.
Product
Nabelsi Thyme (also known on invoices as Zatar) 450g retail (24 packages per wholesale case) 4.5kg retail (2 bags per wholesale case) Cardboard box wholesale case, retail packages flexible plastic
Category
Food
Distribution
5 states
CriticalFDA (Food)·F-2174-2017·2017-05-10
Killer Brownie Distributing Recalls Brownies Due to Undeclared Peanuts
Killer Brownie Distributing LLC is recalling Killer Brownie products due to undeclared peanuts. The mislabeled items were distributed to five states.
Product
NOT-A-NUTTER KB KILLER BROWNIE¿ 3x35 CT NET WT 36 LBS (16.33 kg) CONTAINS: Milk, Soy, Wheat UPC 10858061005314. Item #482-2016
Category
Food
Distribution
5 states
CriticalFDA (Drugs)·D-0691-2017·2017-05-10
EpiPen Jr. Auto-Injectors Recalled for Delivery System Defects
Meridian Medical Technologies is recalling EpiPen Jr. auto-injectors because the delivery system may fail to activate, preventing patients from receiving epinephrine.
Product
EPIPEN — EPIPEN (EPINEPHRINE)
Category
Drug
Distribution
Distributed nationwide