Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
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.
Novis PR, LLC is recalling PreProtein Liquid Predigested Protein dietary supplement because certain bottles are bloated. The recall affects approximately 4,106 units from lot 230118.
Berkshire Innovations is recalling about 990 Sahara Folding Food Dehydrators because the heater fan can fail and cause the unit to overheat, posing a fire hazard. No injuries or property damage have been reported.
ODL Inc. is recalling Severe Weather Doorglass Inserts sold at Home Depot and Lowe's because the adhesive bond can separate during hurricanes, creating a risk of injury and property damage from windborne debris.
Methapharm Inc is recalling Pantoprazole Sodium 40 mg injection vials due to a manufacturing procedure deviation. Affected products were inadvertently placed into distribution without proper compliance with approved procedures.
Aesculap Implant Systems recalls Caspar Cervical Retractor (CCR) Basket lids with incorrect GTIN labeling. The product bears GTIN #04046955299592 instead of the correct #04046955299607.
DuPont Nutrition USA is recalling Avicel DG, a pharmaceutical ingredient, due to failed quality specifications. The product did not meet conductivity standards during manufacturing testing.
DuPont is recalling Avicel PH-200 NF microcrystalline cellulose, a pharmaceutical ingredient, for failing conductivity specifications. The bulk ingredient was distributed to drug manufacturers in the USA and internationally.
Wellness BioSciences is recalling its CBD Metered Dose Inhaler nationwide because it was marketed without an approved NDA/ANDA.
Northwind Pharmaceuticals recalls specific lots of Glimepiride 4mg tablets due to manufacturing practice deviations. Affected tablets were distributed nationwide.
SCA Pharmaceuticals is recalling Oxytocin 30 units in 0.9% Sodium Chloride solution (73,312 containers) nationwide due to subpotency—product contains insufficient active ingredient.
Northwind Pharmaceuticals is voluntarily recalling Glimepiride 2mg tablets distributed nationwide due to Good Manufacturing Practice (CGMP) deviations identified during manufacturing.
DuPont Nutrition USA is recalling specific batches of Avicel PH-101 NF microcrystalline cellulose due to failed conductivity specifications. The pharmaceutical excipient was distributed in bulk to manufacturers in the USA and multiple international locations.
Datascope Corp. is recalling 54 units of the Cardiosave Hybrid Intra-Aortic Balloon Pump distributed to Brazil. The Type J power cord plug is incompatible with Brazilian Type N electrical receptacles.
Northwind Pharmaceuticals voluntarily recalls Tadalafil 20 mg tablets nationwide due to manufacturing practice deviations. No illnesses have been reported.
Northwind Pharmaceuticals is recalling 99 bottles of Atorvastatin Calcium 10 mg tablets nationally due to manufacturing process deviations identified in March 2023.
Northwind Pharmaceuticals is recalling Buspirone Hydrochloride 7.5 mg tablets due to manufacturing process deviations. The FDA Class II recall affects bottles distributed nationwide.
Diamond Visions is recalling about 6,000 Screaming Plush Monkey Toys because the eyes can detach, creating a choking hazard for children. No injuries have been reported.
Medtronic recalled approximately 1414 SenSight Extension Tunneler Kits due to a manufacturing defect where dual carriers were machined on only one side, preventing use for passing two extensions simultaneously.
Nissan is recalling 2013-2017 Leaf vehicles because incorrect owner's manual instructions may reduce defroster performance, limiting windshield visibility.
Ortho-Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 Total N Antibody Calibrators used in COVID-19 testing due to incorrect calibrator levels in Assay Data Disks, which can delay patient test results.
Natural Pak brand Coffee Chili Rub packages contain undeclared Bacon Glaze ingredients including demerara sugar, honey granules, maple sugar, cinnamon, allspice, clove, and parsley. The affected product was distributed in Ohio.
Compass Health Brands is recalling the REX Pressure Therapy System because the user manual incorrectly claims the device can prevent deep vein thrombosis, an indication for which the device was not FDA-cleared.
CVS-distributed earwax removal drops containing carbamide peroxide are being recalled because the active ingredient may degrade and become subpotent before the labeled expiration date, potentially leaving the product ineffective.
Pro-Dex Inc is recalling 199 KLS E-Coupling Adapter devices due to incorrect Unique Device Identifier (UDI) and GTIN codes. The devices were distributed nationwide.
Avanos Medical is recalling Ballard Oral Care Swabs (codes 12241, 12243, 12251) due to incorrect expiration date labeling. The recall affects 5,475 cases distributed worldwide.