Agency
The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.
The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.
FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.
Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.
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.
Bell Pharmaceuticals is recalling Leader Carbamide Peroxide 6.5% Earwax Removal Kit due to subpotency—the active ingredient is significantly reduced (approximately 0.6% versus the expected 6–7%) and the pH is low.
Orthofix U.S. LLC is recalling Orthofix MINIRAIL external fixation devices (Model M101) because they may be labeled with incorrect model numbers, potentially leading to use of wrong device specifications.
Orthofix U.S. LLC is recalling Articulated Minirail Fixator external fixation devices due to incorrect model labeling. Three models were mislabeled: M101 labeled as M103, M103 labeled as M101, and M122 labeled as M111.
Orthofix MINIRAIL unilateral external fixation devices may be labeled with incorrect model numbers. Three model variants (M101, M103, M122) were mislabeled during manufacturing.
Amy's Kitchen is recalling Amy's Organic Soups Lentil Light in Sodium (14.5 oz cans) due to potential for spoilage. The recall affects approximately 15,350 cases distributed across multiple U.S. states and Canada.
Bell Pharmaceuticals is recalling Quality Choice Earwax Removal Kit (Carbamide Peroxide 6.5%) due to subpotent drug content, with assay levels significantly reduced (approximately 0.6% versus expected 6–7%) and low pH levels.
Papablic Inc is recalling Papablic Replacement Brush Heads (Model PAPA317AA) due to potential for brush heads to break. The recall affects approximately 13,400 packs distributed nationwide.
Bell Pharmaceuticals is recalling Good Neighbor Pharmacy Earwax Removal (Carbamide Peroxide 6.5%) due to subpotency—the active ingredient concentration is significantly reduced from expected levels, and the product has a low pH.
Daavlin Distributing Company is recalling Photera 600 3-D phototherapy devices because the UV sensor gain calculation is incorrect, causing inaccurate ultraviolet output measurement.
Bell Pharmaceuticals is recalling Meijer Earwax Removal Kit (Carbamide Peroxide 6.5%) due to subpotency: the product contains significantly reduced active ingredient (~0.6% vs. expected ~6–7%) and low pH, limiting effectiveness.
Medline is recalling 163 kits containing Zimmer Biomet mixing bowls and spatulas due to seal nonconformities that may compromise sterility. The defect could require extended surgery time to locate an alternative device.
Nutricia North America is recalling its NOURISH ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY because testing showed the product contains less vitamin A than the label states. A laboratory error led to inaccurate test results that overstated the actual vitamin A concentration in the product.
Daavlin Distributing Company is recalling the Photera 400 phototherapy device because the UV sensor calibration is calculating incorrectly, resulting in lower output levels than intended.
3B Medical, Inc. is recalling Rio II Nasal Pillows Interface devices due to packaging and labeling discrepancies involving product size identification and device identifiers. The affected models are RII1001 (Small), RII1002 (Medium), and RII1003 (Large).
Adams Extract & Spice LLC is recalling JB Chicken Sknls 35.73# due to undeclared sesame allergen. Consumers with sesame allergies who consume the product face a risk of allergic reaction.
Trafa Pharmaceuticals Inc. is recalling Organic Moringa Leaf Powder due to potential Salmonella contamination. Affected product is Batch #TRF-2025050801, distributed in New York.
Elekta is recalling the Geneva Brachytherapy Applicator due to a safety concern that the tip of the intrauterine tube may detach and remain inside a patient during cancer treatment.
Bortezomib for Injection 3.5mg/Vial manufactured by Reliance Life Sciences is being recalled nationwide due to lack of sterility assurance. Affected lots include RBIH0125A, RBIH0225A, RBIH0325A, and RBIH0525A distributed across the USA.
Adams Extract & Spice LLC is recalling Coopers BBQ 60 Gallon Bean Mix boxes due to undeclared sesame allergen. The product was distributed in Texas.
Reliance Life Sciences is recalling Azacitidine for Injection 100mg/Vial nationwide due to lack of sterility assurance. Patients using affected lots should contact their healthcare provider.
Fresh to You Burger Chicken Fillet Deluxe with Bacon (SKU 10303) is being recalled because raw breaded chicken patties were inadvertently used instead of cooked patties, posing a risk of Salmonella contamination.
Think Surgical is recalling TMINI Femur and Tibia Tracking Arrays used in knee replacement surgery because the knob on the tracking array may loosen, causing potential misalignment of the array.
Elekta's Fletcher CT/MR Shielded Applicator Set is recalled due to risk that the tip of the intrauterine tube may detach and remain inside a patient during gynecological brachytherapy treatment.