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.
Pharmakon Pharmaceuticals is recalling specific lots of Midazolam syringes because they contain twice the stated amount of the drug.
Pure Edge Nutrition is recalling Bella Vi BTrim Ultimate Boost capsules because they contain undeclared sibutramine and phenolphthalein.
Pure Edge Nutrition is recalling Bella Vi BTrim MAX dietary supplements because they contain undeclared sibutramine and phenolphthalein and were marketed without FDA approval.
Vitality Research Labs is recalling vitaliKOR capsules because FDA sampling found undeclared vardenafil and tadalafil. The product was marketed without an approved NDA or ANDA.
MyNicNaxs, Inc. is recalling Magic Slim capsules because they contain undeclared active pharmaceutical ingredients and were marketed without an approved NDA or ANDA.
MyNicNaxs, Inc. is recalling Meizi Evolution Soft Gel Capsules because the product was marketed without an approved NDA/ANDA and contains undeclared active pharmaceutical ingredients.
MyNicNaxs, Inc. is recalling Jianfeijindan Activity Girl Capsules because they contain an undeclared sibutramine analog and were marketed without FDA approval.
MyNicKnaxs is recalling weight reduction pills marketed without FDA approval because they contain undeclared phenolphthalein.
MyNicNaxs, Inc. is recalling REDUCE WEIGHT FRUTA PLANTA Capsules because they contain undeclared phenolphthalein and were marketed without FDA approval.
Pure Edge Nutrition is recalling Bella Vi AMP'D UP weight loss capsules because they contain undeclared sibutramine and phenolphthalein.
Noh Foods International of Hawaii is recalling Hawaiian Coconut Pudding because testing found high levels of undeclared milk allergen.
Ste Fromagere du Livradois is recalling specific lots of Raclette and Montboissie cheeses due to potential Salmonella contamination.
U.S. Trading Co. is recalling Dragonfly Brand Crushed Chili Powder because an FDA sample tested positive for Salmonella B. reilly.
Hospira is recalling 85,680 vials of Marcaine (bupivacaine HCl) injection because a customer complaint confirmed the presence of visible metal particles and discolored solution.
Ste Fromagere du Livradois is recalling specific lots of Raclette and Montboissie cheeses due to potential Salmonella contamination.
Miravalle Foods is recalling 0.75oz bottles of Achiote Molido Ground Annato spice due to potential Salmonella contamination. The product was distributed in seven western states.
Deseo Rebajar is recalling Burn 7 Capsules because they contain undeclared sibutramine and phenolphthalein, which were not approved for use in dietary supplements.
Schindele Enterprises is recalling ExtenZe 600 mg tablets because they contain undeclared sildenafil or tadalafil, which were marketed without an approved NDA or ANDA.
Herbal Give Care Llc is recalling Esbelder Man Herbal Blend because it contains undeclared sibutramine, a drug removed from the U.S. market for safety reasons.
Herbal Give Care is recalling Esbelder Siloutte dietary supplements because they contain undeclared sibutramine, a drug removed from the U.S. market for safety reasons.
Schindele Enterprises is recalling Boost Ultra sexual enhancement supplements because they contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Human Science Foundation is recalling PRO ArthMax tablets because FDA analysis found unapproved prescription drugs in the product.
Schindele Enterprises is recalling XZONE GOLD dietary supplements because they contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Schindele Enterprises is recalling Sexy Monkey dietary supplements because they contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Ben Venue Laboratories is recalling 5,131 vials of Acetylcysteine Solution, USP, 10% due to the presence of glass particulate matter.