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.
DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors are being recalled because the procedure packs contained a recalled product. Approximately 1,306 kits were distributed in Ohio and Tennessee.
Akorn, Inc. is recalling Timolol Maleate Ophthalmic Solution due to identification of an unknown impurity during 12-month stability testing. No illnesses have been reported.
Luxury 70% Isopropyl Alcohol distributed in Virginia by TSM Brands LLC contains undeclared ethyl alcohol, creating a mislabeling hazard. Consumers should stop using the product.
Colgate Anticavity Fluoride Toothpaste OPTIC WHITE ADVANCED ICY FRESH is recalled due to improper temperature storage during manufacturing. Approximately 1,680 packages distributed across 11 U.S. states are affected.
CVS Pharmacy is recalling Nighttime Sleep-Aid tablets because the carton incorrectly identifies the active ingredient as doxylamine succinate HCl instead of doxylamine succinate. Approximately 257,064 cartons were distributed nationwide.
Yem Foods LLC is recalling Priyems Sambar Spicy Lentil Soup for containing undeclared wheat starch in an ingredient. Consumers with wheat allergies should not consume this product.
Yem Foods LLC is recalling Priyems Lemon Pickle due to undeclared wheat starch found in asafoetida, a spice ingredient. Consumers with wheat allergies or celiac disease should not consume affected products.
bioMerieux is recalling specific software versions of VITEK 2 and MYLA diagnostic systems due to seven reported software anomalies that may affect device use.
Padagis US LLC is recalling 57,816 tubes of Triamcinolone Acetonide Cream 0.1% nationwide due to manufacturing process deviations. Consumers reported gritty texture and reduced effectiveness.
Siemens is recalling certain X-ray imaging systems due to a potential hardware issue with the error detection mechanism. In rare cases, this could prevent X-ray emission until system shutdown.
Family Dollar Stores recalls 1,400 packages of Colgate Anticavity Fluoride Toothpaste due to improper temperature storage conditions during manufacturing. The product may not meet quality standards.
The FDA is recalling INTERA 3000 implantable hepatic infusion pumps due to a malfunction causing higher-than-expected medication flow rates. Patients should contact their healthcare provider.
Synapse Biomedical is recalling the NeuRx Diaphragm Pacing System External Pulse Generator due to a circuit board defect causing performance degradation, potentially leading to cardiac complications, breathing failure, or device shutdown.
Tovala is recalling its Gochujang-Glazed Salmon Bowl meal (No. 18-A) because it contains an undeclared peanut allergen. The affected products were distributed nationwide to consumers.
Tovala is recalling approximately 3,340 Gochujang-Glazed Pork Chop Bowl meals distributed nationwide because they contain undeclared peanuts, which pose an allergy risk to consumers with peanut allergies.
Hamilton's HAMILTON-C6 intensive care ventilator status indicator board may become loose, allowing water or disinfectants to enter the device and cause technical faults that could force the ventilator into unsafe modes where patients breathe unassisted room air.
Getinge Servo ventilators may fail to deliver ventilation and stop functioning, potentially causing oxygen deprivation and serious harm to critical care patients.
McKesson Medical-Surgical is recalling MMS - IMMUNOSTICS INC colorectal cancer screening test kits due to facility temperature excursions that may have reduced product effectiveness. The recall affects lots distributed between June and September 2021.
Family Dollar Stores is recalling AD PREV OINT ORIG 4 OZ due to improper storage conditions that may affect product quality. Products distributed nationwide from April 30 through June 10, 2022 are affected.
Family Dollar Stores is recalling multiple eye drop products that were held outside appropriate storage temperature conditions. These products were distributed nationwide between April 30 and June 10, 2022.
Family Dollar Stores is recalling BC Powder and Goody's Powder products due to improper storage temperature conditions. The affected products were distributed nationwide from April 30 through June 10, 2022.
Family Dollar Stores is recalling multiple toothpaste and dental care products that were stored outside appropriate temperature conditions, distributed April 30–June 10, 2022.
Family Dollar Stores is recalling Good Sense Esomeprazole Acid Reducer 20mg bottles due to storage temperature deviations. Affected bottles were distributed between April 30 and June 10, 2022.
GC Milk of Magnesia products (Cherry and Mint, 12 fl oz) distributed to Family Dollar Stores have been recalled due to improper storage temperature. The products may not meet quality and performance standards.
Family Dollar's FS Clotrimazole Anti Fungal Cream is being recalled due to improper storage temperature conditions. The product was distributed nationwide between April 30 and June 10, 2022.