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.

4126–4150 of 7439

CriticalFDA (Food)·F-0656-2016·2016-03-09
Dole Recalls Organic Baby Spinach and Salads from Springfield Facility
Dole is withdrawing all salads produced in Springfield, Ohio, including organic baby spinach, due to a facility suspension.
Product
Organic Baby Spinach - 11 oz. and 5 oz. clamshell - Loblaw 5 oz and 16 oz, Clamshell - Kroger All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package.
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0703-2016·2016-03-09
Trader Joe's Recalls Butternut Squash Triangoli for Undeclared Tree Nuts
Trader Joe's is recalling Butternut Squash Triangoli because it may contain undeclared tree nuts. The recall covers 62,244 units distributed nationwide.
Product
Butternut Squash Triangoli, Net Wt. 8.8 oz (250g)
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0636-2016·2016-03-09
Braga Organic Farms Recalls Pistachios Due to Salmonella Risk
Braga Organic Farms is recalling organic pistachio kernels after an FDA sample tested positive for Salmonella. The product was sold in multiple states and online.
Product
Braga Organic Farms Organic Pistachio Kernels, Raw; Certified Organic, USDA Organic. Packed in 8 oz. 1 lb. 2. lb and 5 lb clear or green standup bags. Ingredients: Organic Pistachios Braga Organic Farms, Madera, CA.
Category
Food
Distribution
45 states
CriticalFDA (Food)·F-0671-2016·2016-03-09
Dole Recalls Mediterranean Salads from Springfield, Ohio Facility
Dole is withdrawing all salads produced at its Springfield, Ohio facility due to a Class I recall. Consumers should stop using products with code A.
Product
Mediterranean, 8 oz. bag. Dole brand. All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package.
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0709-2016·2016-03-09
JEM Raw Organics Coconut Cardamom Sprouted Almond Spread Recalled for Salmonella Risk
Jem Raw Chocolate, LLC is recalling JEM Raw Organics Coconut Cardamom Sprouted Almond Spread due to potential Salmonella contamination. The product was distributed in the US, Canada, Japan, and Germany.
Product
Coconut Cardamom - Sprouted Almond Spread. Product is packaged in glass jars, sold under brand name JEM Raw Organics. Net wt. 1 oz., UPC 6 09728 97863 1 Net wt. 6 oz., UPC 6 09728 97859 4 Net wt. 16 oz., UPC 6 09728 97853 3 The product is labeled in parts: "***ORGANIC
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0682-2016·2016-03-09
Dole Recalls Salads From Springfield Ohio Facility Due to Safety Concerns
Dole Fresh Vegetables Inc is withdrawing all Dole and private label salads produced in Springfield, Ohio, to suspend operations at the facility.
Product
Kale Caesar Kit Bag, 9.2 oz. bag, Dole brand. All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package.
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0638-2016·2016-03-09
Braga Organic Farms Recalls Organic Nut Mix Due to Salmonella
Braga Organic Farms is recalling its Organic Nut Mix because an ingredient, organic pistachios, tested positive for Salmonella. The recall covers products sold in multiple states and online.
Product
Braga Organic Farms Organic Nut l Mix, Raw; Certified Organic, USDA Organic. GMO Free, Peanut Free, Gluten Free Packed in 8 oz. 1 lb. 2. lb and 5 lb and 25 lb. clear or green standup bags. Ingredients: Organic Pistachios, Organic almonds, Organic Cashews, Organic walnuts.
Category
Food
Distribution
45 states
CriticalFDA (Food)·F-0642-2016·2016-03-09
Dole Recalls Spring Salad Mix From Springfield Ohio Facility
Dole is withdrawing all Spring Salad Mix produced at its Springfield, Ohio facility due to a Class I recall. Affected products are sold nationwide and in Canada.
Product
Spring Salad Mix, 5 oz. bag, - Aldi; Walmart; 5 oz, and 10 oz. clamshell - Kroger; Dole - 3 lb. bag, 11 oz and 5 oz.. clamshell All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right h
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0649-2016·2016-03-09
Dole Recalls Salads from Springfield, Ohio Facility
Dole Fresh Vegetables Inc is withdrawing all salads produced at its Springfield, Ohio facility, including Walmart Caesar Bacon Salad Kits, due to a Class I recall.
Product
Caesar Bacon Salad Kit, 14.54 oz. bag - Walmart; All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package.
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0628-2016·2016-03-02
Mahina Mele Farm Recalls Salted Macadamia Nuts Due to Salmonella
Mahina Mele Farm is recalling salted macadamia nuts because samples 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. plastic bag and 16 oz. plastic bag. UPC - 6 oz.: 689076792677; UPC 16 oz.: 689076792974. Mahina Mele Farm 87-2642 Mamalahoa Hwy. Captain Cook, HI 967
Category
Food
Distribution
0 states
CriticalFDA (Food)·F-0630-2016·2016-03-02
Mahina Mele Farm Recalls Bulk Macadamia Nuts Due to Salmonella
Mahina Mele Farm is recalling bulk macadamia nuts because samples tested positive for Salmonella. The recall covers all lots currently in commerce.
Product
Bulk Macadamia Nuts - (salted, unsalted; whole and pieces) Certified Organic Macadamia Nuts, 100% Big Island Grown A raw food. Sold in 5 lb. bag. NO UPC number. Mahina Mele Farm 87-2642 Mamalahoa Hwy. Captain Cook, HI 96704
Category
Food
Distribution
0 states
CriticalUSDA FSIS·021-2016·2016-02-25
Sally Sherman Foods Recalls Chicken Salad Products Due to Listeria Risk
Sally Sherman Foods is recalling approximately 3,004 pounds of chicken salad products due to possible Listeria monocytogenes contamination. No illnesses have been reported.
Product
U.F.S. Industries, Inc. — Sally Sherman Foods Firm Recalls Chicken Salad Products Due to Possible Listeria Contamination
Category
Food
Distribution
5 states
CriticalFDA (Drugs)·D-0675-2016·2016-02-24
Inaffit Recalls Natureal Burn Fat Nature Due to Undeclared Sibutramine
Inaffit, LLC is recalling Natureal Burn Fat Nature capsules because the product contains undeclared sibutramine and was marketed without an approved NDA or ANDA.
Product
NATUREAL BURN FAT NATURE, 30-count capsules, packaged in clear plastic bottle, Manufactured for: Inaffit, LLC. P.O. Box 34056, Bethesda, MD 20827.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0673-2016·2016-02-24
Rhino 7 Platinum 3000 Recalled for Undeclared Active Ingredients
FDA recalls Rhino 7 Platinum 3000 because it contains undeclared active pharmaceutical ingredients, desmethyl carbondenafil and dapoxetine.
Product
Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0615-2016·2016-02-24
Wholesome Soy Products Recalls Mung Bean Sprouts Due to Listeria
Wholesome Soy Products is recalling mung bean sprouts because Listeria monocytogenes was found in the product and production area.
Product
Mung bean sprouts packaged in 10 lb., 15 lb., and 30 lb. plastic bags.
Category
Food
Distribution
1 state
CriticalFDA (Drugs)·D-0671-2016·2016-02-24
Rhino 7 Platinum 3000 Recalled for Undeclared Active Ingredients
MSNV, Inc dba National Video Supply is recalling Rhino 7 Platinum 3000 single blister packs because they contain undeclared active pharmaceutical ingredients.
Product
Rhino 7 Platinum 3000, Single Blister Packs, distributed By Rhino 7, Made in USA
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0674-2016·2016-02-24
Medisca Recalls L-Citrulline API Due to Labeling Error
Medisca Inc is recalling L-Citrulline API bottles because FDA testing found the product contained N-acetyl-leucine instead of the labeled ingredient.
Product
CITRULLINE (L) in 25 g, 100 g, 500 g and 1 kg plastic bottles, White crystals or crystalline powder, odorless, For Use and distribution in prescription compounding, manufacturing, processing, or repackaging only in accordance with FDA regulations and applicable law, Packaged by M
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0668-2016·2016-02-24
Hospira Recalls Magnesium Sulfate Injection Bags Due to Incorrect Barcode Labeling
Hospira is recalling 213,600 bags of Magnesium Sulfate in Water for Injection because the primary bag labeling may be mislabeled with a barcode that scans as heparin sodium.
Product
MAGNESIUM SULFATE IN WATER — MAGNESIUM SULFATE IN WATER (MAGNESIUM SULFATE IN WATER)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-723-2016·2016-02-24
Pharmedium Recalls Subpotent Fentanyl Citrate Syringes for IV Use
Pharmedium Services, LLC is recalling 180 syringes of fentanyl citrate because the drug was subpotent. The affected product was distributed to nine hospital pharmacies.
Product
fentaNYL Citrate, Preservative Free, 5 mcg per mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3479, PharMEDium.
Category
Drug
Distribution
7 states
CriticalFDA (Drugs)·D-0672-2016·2016-02-24
Rhino 7 3000 Recalled for Undeclared Active Pharmaceutical Ingredients
Premiere Sales Group is recalling Rhino 7 3000 bottles because they contain undeclared active pharmaceutical ingredients, desmethyl carbondenafil and dapoxetine.
Product
Rhino 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0667-2016·2016-02-24
APEXXX tablets recalled for containing unapproved sildenafil
Nuway Distributors is recalling APEXXX tablets because they contain sildenafil, an unapproved drug for erectile dysfunction.
Product
APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0664-2016·2016-02-24
Akttive Fat Burner Recalled for Undeclared Dangerous Ingredients
Life and More LLC is recalling Akttive High Performance Fat Burner Gold capsules because FDA testing found undeclared sibutramine, desmethylsibutramine, and phenolphthalein.
Product
Akttive High Performance Fat Burner Gold dietary supplement capsules, 30-count bottle, Distributed by Life and More, L.L.C., Doral, Florida
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0670-2016·2016-02-24
Rhino 7 3000 Recalled for Undeclared Active Pharmaceutical Ingredients
MSNV, Inc dba National Video Supply is recalling Rhino 7 3000 bottles because they contain undeclared active pharmaceutical ingredients.
Product
Rhino 7 3000, 6 count bottles, Distributed by Rhino 7, Made in USA.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0669-2016·2016-02-24
Glades Drugs Recalls Vitamin D3 Supplement Due to Excessive Potency
Glades Drugs Inc. is recalling Vitamin D3 supplement capsules because they contain an extremely high level of vitamin D3.
Product
Vitamin Supplement (Vial) D3, (cholecalciferol (vit D3)/lipoic acid/ubiquinol/ methylcobalamin/pyridoxine/methionine/inositol/choline bitartrate USP) capsules, 60, 120 or 180 count vials, Glades Drugs, 109 S. Lake Ave., Pahokee, FL 33476.
Category
Drug
Distribution
2 states
CriticalFDA (Drugs)·D-724-2016·2016-02-24
Pharmedium Recalls Subpotent Fentanyl Citrate Syringes for IV Use
Pharmedium Services, LLC is recalling 500 syringes of fentanyl citrate because the drug was subpotent. The affected product was distributed to nine hospital pharmacies.
Product
fentaNYL Citrate, Preservative Free, 10 mcg per 1 mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3174, PharMEDium
Category
Drug
Distribution
7 states