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.
Northwind Pharmaceuticals recalls specific lots of Glimepiride 4mg tablets due to manufacturing practice deviations. Affected tablets were distributed nationwide.
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 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.
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.
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.
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.
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.
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.
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.
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.
Rollerblade USA is recalling about 13,400 Fury Inline Skates because the rear brake support can fracture or separate, reducing stability and increasing the risk of falls. No injuries have been reported to date.
Hiland Dairy Foods Company is recalling Hiland Fat Free Chocolate Milk Vitamin A&D sold in Texas. A small number of cartons may contain food grade sanitizer residue.
Pine Pharmaceuticals is recalling 932 syringes of Bevacizumab 2.5 mg/0.1 mL due to incorrect lot number labeling on the primary packaging. The affected lot (#66377, expiration 06/28/2023) was distributed nationwide.
Solta Medical is recalling one Thermage CPT System unit that was potentially improperly tested and calibrated during manufacturing. The company is contacting the affected customer regarding corrective action.
Hetero USA Inc. is recalling 2,352 bottles of Pantoprazole Sodium 40mg tablets due to manufacturing deviations that caused discoloration. The affected lot (PAN22542, exp. 9/2024) was distributed nationwide.
Coloplast Manufacturing recalls 20 units of Titan 0-Deg Scrotal inflatable penile prosthesis (Lot Numbers 8849601, 8849600, 8849621) with worldwide distribution. The specific reason for the recall is not specified in FDA records.
Jost Chemical Co is recalling Magnesium Citrate Tribasic Hydrate powder due to elevated microbial counts above the manufacturer's specification. Lot 25350037 (3,300 pounds) was distributed to Florida.
Pfizer recalls 1,926 bottles of MEKTOVI (binimetinib) due to incorrect expiration dates on labels. Bottles labeled March 2026 actually expire February 2025.
Coloplast Manufacturing is recalling the Titan 0-Deg Scrotal 18 Cm inflatable penile prosthesis (25 units) due to decreased wall thickness that may cause premature pump failure. Patients with affected lot numbers should contact their healthcare provider.
Angiodynamics recalls NanoKnife 5-Probe Procedure Packs due to a programming error affecting RFID function. The probes may not be recognized by the NanoKnife generator, potentially delaying surgical procedures.
TIPPCON LLC is recalling Perrona Hot Sauce Original with Chiltepin Peppers due to mold growth on the outside of the bottle. The affected product was distributed nationwide.
FKC LLC is recalling Frisch's Tuna Salad in 4-pound tubs distributed in Ohio, Kentucky, and Indiana due to condensation observed falling into the food.