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.
Zydus Pharmaceuticals USA Inc. is recalling 13,320 bottles of Venlafaxine Hydrochloride 75 mg tablets due to a complaint of excessive broken or chipped tablets.
Biomerieux Inc is recalling VITEK 2 AST-ST01 Streptococcus Susceptibility Cards because the package insert did not list the correct limitations of use and performance requirements.
Cardinal Health is recalling sterile needle counters with blade disarmers because small holes in the packaging may compromise sterility.
CareFusion 213, LLC is recalling 698,000 SEPP 70% Isopropanol applicators because the product is not sterile, making the labeling misleading regarding sterility claims.
Servatii Inc is recalling 90 one-pound packages of Banana Nut Bread because the ingredient list incorrectly identifies walnuts instead of pecans.
Hill Dermaceuticals is recalling 8,592 bottles of Derma-Smoothe/FS topical oil because the product was found to be subpotent at a 22-month stability timepoint.
Synthes USA HQ, Inc. is recalling 148 Dens Instrument Sets because there are no screws specifically indicated for the procedure.
Physicians Total Care is recalling Tetracycline 500 mg capsules due to a potential for foreign particulate matter in the active pharmaceutical ingredient.
Becton Dickinson & Co. is recalling BD MAX PCR Cartridges because they may not seal properly, potentially causing false or invalid test results.
Toshiba is recalling 95 Infinix-i X-Ray systems because a software error may display incorrect images or cause image loss during fluoroscopy.
Biosense Webster is recalling 54 units of the 20-Pole Eco Cable because incorrect calibration prevents the connected catheter from being recognized by the system.
Orthohelix Surgical Designs Inc is recalling specific lots of Intraosseous Fixation System drill bits because a burr prevents them from fitting over the guide wire.
West-ward Pharmaceutical Corp. is recalling Ciprofloxacin 500 mg tablets due to a complaint of rubber-like material found in a tablet.
Genetic Testing Institute is recalling 386 lots of LIFECODES PF4 Enhanced assay kits because inconsistent values can lead to invalid test results.
CareFusion is recalling Blood Culture Prep Kit II units because the product is not sterile, making the labeling misleading regarding sterility claims.
Physicians Total Care is recalling Tetracycline 250 mg capsules due to a potential for foreign particulate matter in the active pharmaceutical ingredient.
CareFusion is recalling SEPP 10% Povidone Iodine Solution applicators because the product is not sterile, making the sterility claims on the label misleading.
CareFusion 213, LLC is recalling 46,500 Donor Prep Kits because the labeling is misleading regarding sterility claims. The product is not sterile.
CareFusion 213, LLC is recalling SEPP 2% Iodine Tincture applicators because the product is not sterile, making the labeling misleading regarding sterility claims.
Cardinal Health is recalling specific lots of sterile needle counters because small holes in the packaging may compromise sterility.
Kettle Foods is recalling 1,943 cases of Honey Roast Harvest trail mix because it was made with dried pineapple containing sulfur dioxide instead of untreated pineapple.
Cardinal Health is recalling sterile needle counters with blade disarmers because small holes in the packaging may compromise sterility.
Cardinal Health is recalling sterile needle counters because small holes in the packaging may compromise sterility. The recall affects units distributed in the US, Australia, Canada, and Japan.
Abbott is recalling ARCHITECT HBsAg assay files because they were mistakenly made available on its website and via AbbottLink notifications.
Cooper Surgical is recalling 80 Omniflex Diaphragms because the incorrect size was printed on the outer packaging.