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 CB1101001 BARRA XXL bars distributed in Florida due to potential contamination with insect filth. Consumers with affected lot codes should discard the product.
McKesson Medical-Surgical is recalling Nitrostat (nitroglycerin sublingual tablets) 0.4 mg due to manufacturing deviations involving temperature abuse that may affect product quality. The affected product was distributed nationwide.
McKesson Medical-Surgical is recalling TOBRADEX ophthalmic ointment nationwide due to cGMP deviations involving temperature abuse. Product distributed between June 1 and September 30, 2021 may be affected.
Revonto (dantrolene sodium) injection is being recalled due to manufacturing deviations involving temperature abuse. Approximately 49 cartons were distributed nationwide; healthcare providers should contact their supplier for guidance.
McKesson is recalling 9 vials of Duraclon (clonidine HCl) injection nationwide due to temperature deviations that violated current Good Manufacturing Practice (cGMP) standards.
McKesson Medical-Surgical is recalling Azithromycin for Injection 500 mg vials nationwide due to temperature control deviations identified during manufacturing.
ROi CPS LLC has recalled the Regard GS0098C bronchoscopy kit because it contained Medline Endoscopy Bedside Cleaning products that were previously recalled.
Novartis is recalling Xiidra ophthalmic solution professional samples nationwide due to failed impurities and degradation specifications.
McKesson Medical-Surgical is recalling Naltrexone Hydrochloride 50 mg tablets distributed nationwide due to cGMP deviations related to temperature abuse during manufacturing.
McKesson Medical-Surgical is recalling 29 boxes of Aprepitant 40 mg capsules nationwide due to temperature abuse during manufacturing that violated current Good Manufacturing Practice standards.
McKesson Medical-Surgical is recalling DIPRIVAN (Propofol) injectables nationwide due to temperature abuse during distribution that may have affected product stability. The recall involves 46 cartons.
McKesson Medical-Surgical has recalled Ipratropium Bromide and Albuterol Sulfate inhalation solution due to temperature abuse during storage that resulted in cGMP deviations. The nationwide recall affects 56 pouches; no illnesses or injuries have been reported.
McKesson Medical-Surgical is recalling Depo-Medrol (methylprednisolone acetate) 80mg/mL injectable suspension due to manufacturing temperature control deviations. The recall affects 177 cartons distributed nationwide.
Mckesson Medical-Surgical is recalling Lidocaine Patch 5% due to temperature abuse during distribution that may affect product quality and efficacy. Affected patches were distributed nationwide.
Teva Pharmaceuticals USA Inc is recalling Alprostadil Injection USP due to out-of-specification results for impurities identified during routine stability testing. This FDA Class III recall affects 3,109 cartons distributed nationwide.
Novartis is recalling Xiidra (lifitegrast ophthalmic solution) 5% professional samples nationwide due to failed impurities and degradation quality specifications. The recall affects 279,179 vials across three lot numbers.
Walnut Creek Chocolate Co Inc is recalling Peanut Butter Caramel Corn due to potential Salmonella contamination. The recall affects 234 units distributed to multiple U.S. states.
JIF Natural Peanut Butter in 0.64 oz individual packs is being recalled due to potential Salmonella contamination. The recall affects 47,918 cases distributed nationwide.
The FDA recalled JIF 16 Ounce Creamy Omega 3 Peanut Butter due to potential Salmonella contamination. Approximately 33,516 cases distributed nationwide are affected.
The JM Smucker Company is recalling JIF Reduced Fat Creamy Peanut Butter in 16-ounce and 40-ounce containers due to potential Salmonella contamination. The recall affects approximately 454,971 cases distributed nationwide.
Mary's Harvest brand Apple Peanut Butter Cups are being recalled due to potential Salmonella contamination. The recall affects 450 cups distributed in Oregon and Washington with use-by dates between May 15 and May 30, 2022.
Walnut Creek Chocolate Co Inc is recalling Ritz Peanut Butter due to potential Salmonella contamination. The recall affects 682 units distributed across 29 states.
Walnut Creek Chocolate Co Inc is recalling Assorted Chocolate Heart Boxes due to potential Salmonella contamination. Consumers should not consume the recalled products.
JIF 1.5 oz Creamy Peanut Butter To Go products manufactured by The JM Smucker Company may contain Salmonella. The recall affects 330,528 cases distributed to all 50 states.
The JM Smucker Company is recalling JIF Creamy Peanut Butter in multiple sizes due to potential Salmonella contamination. The recall affects millions of cases distributed to all 50 states.