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.
Able Groupe Inc is recalling HiPP UK Stage 1 Combiotic First Infant Milk Formula because required pre-market FDA notifications were not submitted. Some products contain insufficient iron and lack mandatory labeling.
Teva Pharmaceuticals USA is recalling Methylprednisolone Acetate Injectable Suspension USP 40 mg/mL in single-dose and multi-dose vials nationwide due to lack of assurance of sterility.
Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection (350 mg/vial) distributed nationwide because the manufacturer cannot assure the product is sterile. Patients using recalled lot should consult their healthcare provider.
Teva Pharmaceuticals USA is recalling Epoprostenol Sodium for Injection (1.5 mg/vial, 10 mL vials) due to lack of assurance of sterility. The affected lot was distributed nationwide.
Able Groupe Inc is recalling Lebenswert Folgemilch Stage 2 Organic Follow-On Infant Milk Formula (76,000 units) sold directly through littlebundle.com. The formula was not submitted for required FDA pre-market notification and lacks mandatory English-language labeling.
Able Groupe Inc is recalling HiPP UK Stage 2 Combiotic Follow-On Infant Milk Formula because required pre-market FDA notifications were not submitted and products lack mandatory English-language labeling as required by federal regulations.
Able Groupe Inc is recalling Holle Bio Stage 2 Organic Follow-On Infant Milk Formula because required FDA pre-market notifications were not submitted and the product lacks mandatory labeling in English required by federal regulations.
Teva Pharmaceuticals USA is recalling Norepinephrine Bitartrate Injection, USP 4 mg/4 mL vials due to lack of assurance of sterility. The product was distributed nationwide.
Daimler Trucks North America is recalling 2016-2021 Thomas Built Buses Saf-T-Liner HDX school buses because a power steering hose may be routed with inadequate clearance, increasing the risk of a fire.
Teva Pharmaceuticals is recalling Octreotide Acetate Injection 100 mcg/mL (Lot #31327466B, expiring 08/2021) nationwide due to lack of assurance of sterility. The affected product was distributed nationwide, including Puerto Rico.
Teva Pharmaceuticals USA is recalling Idarubicin Hydrochloride Injection 20 mg/20 mL vials nationwide due to lack of assurance of sterility. The recall affects 2,091 vials distributed across the United States and Puerto Rico.
Zydus Pharmaceuticals is recalling Carvedilol 25 mg tablets nationwide after Paroxetine tablets were found mixed into bottles. Patients should not take affected bottles and contact their pharmacy or doctor.
Able Groupe Inc is recalling Holle Bio Stage 1 Organic Infant Milk Formula because the product may contain insufficient iron for some infants and lacks required FDA labeling statements. The recall affects approximately 76,000 units sold directly through littlebundle.com.
Mane Inc is recalling Flavored Bacon Ranch Seasoning packaged in 25lb kraft paper bags due to Salmonella detected in an ingredient used during manufacturing. The affected product was distributed to manufacturers in Ohio, Indiana, Minnesota, and Oregon.
Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection (350 mg/vial) distributed nationwide because the manufacturer cannot assure the product meets sterility standards.
Able Groupe Inc is recalling HiPP German Stage 1 Combiotic Infant Milk Formula because required FDA pre-market notifications were not submitted. Some units contain inadequate iron levels and lack required English labeling.
Willow Tree Poultry Farm is recalling approximately 52,022 pounds of chicken salads and dips that may contain hard white plastic. The products were distributed to nine northeastern states.
PL Custom is recalling 2019 Dodge RAM 5500 emergency vehicles because rear brake lines may wear, risking brake loss and crashes.
Crane Carrier is recalling 94 LET2 vehicles from 2020-2021 because a fuel hose may leak, increasing the risk of fire if exposed to an ignition source.
Reitnouer is recalling 2017-2019 Steer Axle trailers because the steering arm may detach, potentially causing loss of control or road hazards.
PACCAR is recalling certain 2021-2022 Peterbilt commercial trucks due to insufficient clearance in the Hill Start Assist valve assembly, which may damage the rear brake hose and disable rear braking. Dealers will inspect and repair the assembly free of charge.
Med Shop Total Care Inc. is recalling Hydromorphone HCL-Bupivacaine HCL PF Injectable in 21 and 22 mL syringes in various strengths distributed in Texas and Puerto Rico due to non-sterility concerns.
Ravin Crossbows is recalling white arrow nocks that can fail to engage properly with the bowstring, allowing the crossbow to discharge unexpectedly during re-nocking and causing finger injuries. About 220,000 units are affected.
Medtronic is recalling the HeartWare HVAD left ventricular assist pump after observational data showed higher rates of neurological adverse events and mortality compared to alternative devices, plus reports of pump restart failure.
Med Shop Total Care is recalling injectable drug syringes containing hydromorphone, bupivacaine, and baclofen due to non-sterility. The affected products were distributed in Texas and Puerto Rico.