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.
FDA is recalling Xylocaine (lidocaine HCl) injections due to the presence of particulate matter, specifically hair found in the product.
Bionpharma Inc. is recalling Divalproex Sodium Delayed-Release Tablets, 500 mg, because some bottles may contain foreign tablets or capsules.
Wilcox Industries Corp. is recalling BOSS Xe family aiming devices to implement a software enhancement designed to increase safety.
Boston Scientific is recalling 18 FARASTAR Ablation Generator EU devices due to missing FARAPOINT PFA catheter information in the Instructions For Use.
Ascend Laboratories is recalling 6,192 bottles of Amlodipine and Olmesartan Medoxomil tablets nationwide due to failed dissolution specifications and Olmesartan content below specifications.
Prismatik Dentalcraft, Inc. is recalling Silent Nite Sleep Appliances because the device does not have FDA clearance.
Fresenius Kabi is recalling Glycopyrrolate Injection due to the presence of particulate matter, specifically hair found in the product.
Kent Imaging, Inc. is recalling SnapshotGLO Wound Imaging Devices (Models KB100 and KB100AA) because software issues may prevent the device from recharging.
Ascend Laboratories is recalling 2,717 cartons of Dabigatran Etexilate Capsules, 150 mg, because stability testing found impurities above specification.
Micro Therapeutics, Inc. is recalling Pipeline Flex Embolization Devices because the labels may incorrectly state the implant length.
Jayco is recalling 2026 Entegra Anthem motorhomes because the vehicle certification label may list the wrong tire size, which could lead to installing incorrect replacement tires.
Bell Pharmaceuticals is recalling Audiologist's Choice Carbamide Peroxide earwax removal product due to subpotency: the active ingredient concentration is approximately 0.6% instead of the expected 6–7%, and the product has low pH.
Bell Pharmaceuticals recalls Foster & Thrive Carbamide Peroxide 6.5% due to subpotent drug substance with low pH and significantly reduced assay levels. Approximately 31,094 units distributed nationwide are affected.
Bell Pharmaceuticals is recalling Clinere Ear Wax Remover nationwide because the product contains significantly reduced active ingredient and low pH. The affected lots were distributed throughout the United States.
Nutricia North America is recalling Liquid Hope Organic Whole Foods Meal Replacement Peptide Formula Berry Medley because the product contains less vitamin A than labeled. A testing laboratory used an incorrect method that overstated the vitamin A concentration.
Medline Industries is recalling 163 kits containing Zimmer Biomet mixing bowls and spatulas due to seal defects that risk sterility breach during surgical procedures.
Bell Pharmaceuticals is recalling TopCare Earwax Removal Kit (Carbamide Peroxide 6.5%) because the drug is subpotent with significantly reduced active ingredient (~0.6% vs. expected 6–7%) and low pH. The affected product was distributed nationwide.
Papablic Inc is recalling certain Papablic18B replacement brush head packs because the brush heads may break during use.
Intuitive Surgical is recalling da Vinci SP Instrument Arm Drapes because the drape rings may detach, exposing the instrument arm and potentially delaying procedures. The recall affects 11,113 units distributed worldwide.
CVS Health Earwax Removal Drops are being recalled because the product contains significantly reduced active ingredient (approximately 0.6% instead of the expected 6–7%) and has low pH. The recalled product may not work as intended.
Family Wellness Carbamide Peroxide 6.5% earwax removal kits are being recalled because they are subpotent with low pH and significantly reduced active ingredient content (approximately 0.6% versus the expected 6–7%). Consumers should stop using affected lots and consult their pharmacist.
Padagis US LLC is recalling Nystatin Cream USP (100,000 USP units) because long-term stability testing found assay results below specification, meaning the product may contain less active ingredient than labeled.
CAREone Earwax Removal Drops (Carbamide Peroxide 6.5%) are recalled because the product contains significantly reduced active ingredient (~0.6% vs. expected ~6–7%) and low pH, making it ineffective.
Daavlin Distributing Company is recalling 26 Photera 600 phototherapy devices nationwide because the UV sensor gain calibration is incorrect, causing inaccurate ultraviolet output readings.
Tosoh Bioscience is recalling ST AIA-Pack Testosterone test kits due to low-quality control results that could produce falsely elevated or falsely low testosterone measurements, potentially leading to unnecessary testing or delayed diagnosis.