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.
The FDA is recalling Hard Times For Men capsules because they contain undeclared sildenafil and were marketed without an approved NDA or ANDA.
Fresh Pak, Inc. is recalling Aunt Mid's Michigan Apples slice bags due to potential Listeria monocytogenes contamination. The product was distributed in Michigan, Ohio, and Wisconsin.
Fieldbrook Foods is recalling Orange Cream Ice Cream Bars sold under multiple brand labels due to potential Listeria monocytogenes contamination.
California Popsicle, Inc. is recalling Polly Ann Green Bean Ice Cream Bars because they contain undeclared milk. The product was distributed in New York, California, and Canada.
Fieldbrook Foods is recalling chocolate covered vanilla ice cream bars due to potential Listeria monocytogenes contamination. The products were distributed nationwide, including Puerto Rico.
Evershing International Trading Inc. is recalling Coconut Tree Brand Shredded Coconut after Massachusetts testing detected Salmonella.
Fieldbrook Foods is recalling ice cream variety packs due to potential Listeria monocytogenes contamination. The products were distributed nationwide, including Puerto Rico.
H.I.G. Corporation is recalling 522 cases of frozen tuna fillet saku because customer testing detected Listeria monocytogenes.
Fieldbrook Foods is recalling Sundae Shoppe Raspberry Cream Ice Cream Bars due to potential Listeria monocytogenes contamination. The product was distributed nationwide, including Puerto Rico.
Hong Chang Corporation is recalling 515 cases of Hanryosued (F. Dashi Anchovy) because the dried fish was un-eviscerated or partially eviscerated.
Rich Products Corporation is recalling approximately 3,420 pounds of frozen beef meatballs that may be contaminated with Listeria monocytogenes.
Perdue Foods is recalling approximately 530 pounds of chicken breast tenderloin fritters because they contain egg whites, an undeclared allergen.
Café Spice GCT Inc. is recalling ready-to-eat chicken salad products because they contain milk, an undeclared allergen, and are mislabeled as chicken wraps.
Kotecha Brothers LLC is recalling Haldiram's Fresh Paneer after a sample tested positive for Listeria monocytogenes. The product was distributed to Florida consignees.
Nodine's Smokehouse Inc. is recalling smoked salmon packages nationwide due to potential Listeria monocytogenes contamination.
Mazda is recalling 2,205 model year 2006 B-Series trucks because the driver-side air bag inflator may explode upon deployment, posing a risk of serious injury or death.
Rachael's Food Corporation is recalling Springfield Smoked Fish Whitefish Salad due to potential Listeria monocytogenes contamination.
Rachael's Food Corporation is recalling Springfield Smoked Fish Smoked Bluefish because it may be contaminated with Listeria monocytogenes.
Rachael's Food Corporation is recalling Springfield Smoked Fish Smoked Sable because it may be contaminated with Listeria monocytogenes. The product was sold nationwide through retail and online channels.
Rachael's Food Corporation is recalling specific Veggie Cream Cheese Spread products due to potential Listeria monocytogenes contamination.
Natures Supplement is recalling Enhanced Vegetal Vigra 200 mg capsules because FDA analysis found the product was tainted with Sildenafil and marketed without an approved NDA/ANDA.
Rachael's Food Corporation is recalling Traditional Kippered Salmon due to potential Listeria monocytogenes contamination. The product was sold nationwide through retail and online channels.
Fresenius Kabi is recalling 203,136 syringes of Midazolam Injection that were mislabeled and actually contain Ondansetron Injection.
Rachael's Food Corporation is recalling Springfield Smoked Fish Belly Lox due to potential Listeria monocytogenes contamination. The product was sold nationwide.
Rachael's Food Corporation is recalling its Smoked Fish Strawberry Cream Cheese Spread due to potential Listeria monocytogenes contamination.