Severity 4 of 5
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.
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.
Hy-Vee is recalling Rock N Roll Shrimp 10Ct due to potential contamination with Listeria monocytogenes. The product was distributed to retail locations throughout the Midwest.
Thrive Health Solutions is recalling Methylcobalamin Injectable 10mg/mL pre-filled syringes (Lot #H228307, expiration 12/27/2025) due to lack of assurance of sterility. The affected product was distributed nationwide.
Advanced Pharmaceutical Technology, Inc. is recalling TESTO-200 (Testosterone Cypionate Injection USP, 200mg/ml) because it was marketed without an approved NDA or ANDA.
Apotex Corp. is recalling 6,288 bottles of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution nationwide due to lack of assurance of sterility. The affected batch (VC6058, expiration date 10/31/2025) does not meet sterility requirements for ophthalmic use.
Thrive Health Solutions is recalling NAD+ 100mg/mL pre-filled syringes (Lot GA37484) because the manufacturer cannot assure the product is sterile. The product was distributed nationwide.
Hy-Vee is recalling Duo Crunchy Veg Shrimp 10Pc due to potential contamination with Listeria monocytogenes. The affected product was distributed to retail locations throughout the Midwest.
Becton Dickinson is recalling BD BACTEC MGIT 960 PZA Kit due to reports of intermittent false resistance results during pyrazinamide susceptibility testing of Mycobacterium tuberculosis. The issue affects units distributed worldwide.
Thrive Health and Wellness, LLC is recalling LL Bioboost Injectable pre-filled syringes nationwide due to lack of assurance of sterility. The affected product is Lot #H277639 with expiration 6/25/2025.
Bornstein Seafoods Inc. is recalling frozen shrimp meat products after Listeria monocytogenes was detected during the firm's routine testing. The products were distributed nationwide and in Canada.
Isabelle's Kitchen, Inc. is recalling Greek Pasta Salad in 4.5 lb. containers due to Salmonella contamination. The recalled products were distributed to Pennsylvania and Maryland.
Hy-Vee is recalling Spicy Shrimp Poke Bowl products due to potential contamination with Listeria monocytogenes. The product has been distributed to retail locations throughout the Midwest.
Hy-Vee is recalling Duo Crispy Calif Shrimp 10Pc due to potential contamination with Listeria monocytogenes. Affected cases were distributed to retail locations throughout the Midwest.
Isabelle's Kitchen, Inc. is recalling Mediterranean Pasta Salad due to Salmonella contamination. The affected product was distributed in Pennsylvania and Maryland.
Integra LifeSciences Corp. is recalling the MicroMyst Applicator Box of 5 due to lack of sterility assurance. The product is used with the Integra Flow Source for controlled application of two liquids.
Hy-Vee is recalling Crunchy Shrimp Roll due to potential contamination with Listeria monocytogenes. The affected product was distributed to retail locations throughout the Midwest.
Thrive Health Solutions is recalling CJC-1295 Injectable 6mg/15mg pre-filled syringes due to lack of assurance of sterility. The affected product was distributed nationwide.
B Braun Medical Inc. is recalling 187,656 containers of 0.9% Sodium Chloride Injection USP due to potential sterility failures caused by pinholes in finger boxes during manufacturing. The defect may allow leaks and compromise the sterile nature of the intravenous medication.
Thrive Health Solutions is recalling Semaglutide 5 mg/mL pre-filled syringes distributed nationwide because the manufacturer cannot assure the product's sterility.
Thrive Health Solutions is recalling one lot of Tirzepatide/Cyanocobalamin Injectable pre-filled syringes due to lack of assurance of sterility. The affected product is Lot C03125A distributed nationwide.
Thrive Health Solutions is recalling Semaglutide 2.5 mg/mL pre-filled syringes (Lot #H270221) because the manufacturer cannot assure sterility of the product.
Homegrown Family Foods LLC is recalling Shore Lunch Breading & Batter Mix Oven Style because it contains undeclared milk, a common allergen. The product was distributed across multiple Midwestern and East Coast states.
Hy-Vee is recalling Crispy Shrimp Roll 10Pc due to potential Listeria monocytogenes contamination. Consumers should not consume the product.
Hy-Vee is recalling Red Dragon Roll products due to potential contamination with Listeria monocytogenes. The recall affects 122.5 cases distributed to retail locations throughout the Midwest.
Mightylicious Inc. is recalling MIGHTYLICIOUS Vegan Oatmeal Coconut Cookies because they contain undeclared milk, a common allergen not listed on the label. The product was distributed to Rhode Island, Illinois, and New York.
Integra LifeSciences is recalling Extended Tip Applicator 8CM devices nationwide and internationally because they may contain potentially out-of-specification endotoxin levels and lack sterility assurance.