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.
GRUVIPA S.L. is recalling CB1101006 BARRA LARGA CON SALVADO cereal bars due to potential insect filth contamination. Affected lots were distributed in Florida.
McKesson Medical-Surgical is recalling an Epidural Nerve Block Tray (model #182207) distributed nationwide due to temperature abuse during manufacturing that violates cGMP standards. The exposure may compromise device sterility required for safe epidural procedures.
McKesson Medical-Surgical is recalling Promethazine HCl Tablets, 25 mg, due to temperature deviations during manufacturing that did not comply with current good manufacturing practices. The recall affects 16 cartons distributed nationwide.
Cook Incorporated is recalling Hilal Embolization Microcoils because their loading cartridges may contain an unintended stainless-steel cannula. The recall affects 106,033 units distributed nationwide and internationally.
McKesson is recalling Revonto (dantrolene sodium injection) due to temperature abuse during storage and distribution affecting 16 cartons distributed nationwide.
McKesson Medical-Surgical is recalling Sumatriptan Injection, USP, 6mg/0.5mL nationwide due to temperature abuse during distribution that may have affected medication stability and potency.
McKesson Medical-Surgical is recalling Tropicamide Ophthalmic Solution, 1% USP, due to temperature control deviations during manufacturing. The recall affects 31 bottles distributed nationwide.
McKesson Medical-Surgical recalls Smiths Medical spinal trays due to manufacturing temperature deviations. Approximately 8 cases were distributed nationwide.
McKesson Medical-Surgical is recalling Metronidazole 250 mg tablets manufactured by Major Pharma due to temperature deviations during manufacturing that could affect drug potency. Patients should consult their pharmacist or doctor.
Cook Incorporated is recalling certain Tornado Embolization Microcoils due to unintended stainless-steel cannulas in loading cartridges. The foreign objects may affect device function.
McKesson Medical-Surgical Inc. is recalling Pilocarpine HCL Ophthalmic Solution due to temperature abuse during manufacturing that may affect product stability. The product was distributed nationwide.
Geodon for injection (ziprasidone hydrochloride) 20 mg/mL vials are being recalled nationwide due to cGMP deviations involving temperature abuse. The FDA classified this as a Class II recall.
McKesson Medical-Surgical is recalling Ampicillin for Injection nationwide due to cGMP deviations involving temperature abuse during manufacturing that may have compromised drug quality.
Craftology and Busch's baked beans are being recalled due to metal contamination in the bacon component. Products were distributed in Michigan.
GE Healthcare's Centricity PACS RA1000 medical imaging software may display inaccurate distance and area measurements on magnified or scaled images, potentially affecting diagnostic accuracy.
Encore Medical is recalling DJO EMPOWR 3D Knee tibial inserts because packages may contain a mismatched left-size component instead of the correct right-size implant. If implanted, the wrong component could leave debris in the joint.
Celestone Soluspan injectable suspension is being recalled for manufacturing temperature control deviations that violated good manufacturing practices. McKesson distributed 51 vials nationwide.
McKesson Medical-Surgical is recalling Betadine 5% Sterile Ophthalmic Prep Solution nationwide due to manufacturing deviations involving temperature abuse during production.
McKesson Medical-Surgical is recalling Bupivacaine HCl Injection due to cGMP deviations caused by temperature abuse during manufacturing. The recall affects 32 cartons of 25-vial packages distributed nationwide.
McKesson Medical-Surgical is recalling 157 kits of Thrombin JMI nationwide due to temperature exposure during manufacturing that may have affected product quality and efficacy.
HP Hood LLC recalls PLANET OAT Chocolate Chip Cookie Dough frozen dessert due to possible undeclared peanuts. Consumers with peanut allergies should not consume this product.
Helena Laboratories is recalling the V8 Immunodisplacement Kit (51 units) due to microbial contamination that interferes with test interpretation. The FDA Class II recall affects kits distributed in the U.S. and internationally.
McKesson Medical-Surgical is recalling 25 kits of Firmagon (degarelix for injection) 80 mg nationwide due to temperature abuse during manufacturing. No illnesses have been reported.
McKesson Medical-Surgical is recalling DEPO-MEDROL (methylprednisolone acetate) injectable suspension nationwide due to temperature abuse during manufacturing that may have affected product quality. No illnesses have been reported.
McKesson Medical-Surgical is recalling 26 cases of Cefazolin Sodium injection due to manufacturing deviations involving temperature abuse. The product was distributed nationwide.