Severity 5 of 5
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.
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.
J Bar B Foods is recalling approximately 4,050 pounds of chicken sausage products because they contain milk, a known allergen, that is not declared on the label.
Medtronic is recalling 951 Evera ICDs and CRT-Ds because a defect may prevent the devices from delivering high or low voltage therapy.
Medtronic is recalling 951 Compia MRI CRT-Ds because a defect may prevent the delivery of high and low voltage therapy.
The Compounding Pharmacy of America is recalling 5 vials of HCG and Methylcobalamin injection due to non-sterility. The product was distributed in Tennessee and South Carolina.
ABH Nature's Products is recalling Arthri-D 120ct bottles because they may be contaminated with Salmonella. The product was distributed directly to Massachusetts and Pennsylvania.
Magno Humphries Laboratories is recalling Senna Laxative tablets that were mislabeled and contained Naproxen Sodium instead.
Panera, LLC is recalling Plain Cream Cheese in 2 oz. and 8 oz. sizes due to potential Listeria monocytogenes contamination. The product was sold nationwide at Panera Cafes.
Panera, LLC is recalling Chive & Onion Reduced Fat Cream Cheese Spread due to potential Listeria monocytogenes contamination.
Bulletproof 360 Inc is recalling Unflavored Collagen Protein because the product contains undeclared milk. The item is mislabeled as collagen protein but actually contains whey protein.
AuroMedics Pharma LLC is recalling 9,050 bags of Linezolid Injection 600 mg/300 mL because white particulate matter identified as mold was found in one bag.
AuroMedics Pharma LLC is recalling 66,100 vials of Pantoprazole Sodium for Injection because one vial contained a piece of glass.
Brenckle Farms is recalling fresh cilantro from Hartville, Ohio, after being notified that the product contains Listeria monocytogenes.
Productos Pacheco, Inc. is recalling Vanilla Cake with Cheese due to undeclared allergens including wheat, soy, milk, and food dyes.
Productos Pacheco, Inc. is recalling Polvorones NET WT 4OZ due to undeclared soy and wheat allergens. The product was distributed to consignees in Puerto Rico.
Panera is recalling Reduced-Fat Honey Walnut Cream Cheese due to potential Listeria monocytogenes contamination. The product was sold nationwide at Panera Cafes.
Aurobindo Pharma is recalling 53,040 vials of Ampicillin and Sulbactam for Injection due to a confirmed report of visible glass particulate matter.
Panera, LLC is recalling Reduced-Fat Wild Blueberry Cream Cheese because it may be contaminated with Listeria monocytogenes. The product was sold nationwide at Panera Cafes.
A&H Focal Inc. is recalling Zhonghua Niubian tablets found to contain sildenafil, an unapproved drug for erectile dysfunction.
A&H Focal Inc. is recalling LANG YI HAO CHAONONGSUOPIAN tablets because they contain sildenafil without FDA approval. The products were sold in New York and New Jersey.
Premier Produce is recalling one lot of Jicama Julienne contaminated with Listeria monocytogenes. The product was distributed to U.S. consignees.
International Laboratories, LLC is recalling Clopidogrel Tablets 75 mg because bottles were found containing Simvastatin Tablets 10 mg.
Blue Fusion Natural is recalling Blue Pearl capsules because FDA analysis found undeclared sildenafil, an unapproved drug for erectile dysfunction.
Guymon Extracts Inc. is recalling approximately 4,202 pounds of fully cooked pork products due to a processing deviation that may have allowed pathogen growth.
BotanicalNow is recalling BodySlim Herbal capsules because FDA analysis found undeclared sibutramine, a substance not approved for use in this product.
Fresh Pak, Inc. is recalling Aunt Mid's brand sliced apples and grapes bags due to potential Listeria monocytogenes contamination. The product was distributed in Michigan, Ohio, and Wisconsin.