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.
The JM Smucker Company is recalling JIF 16 Ounce Natural Creamy Peanut Butter with Honey due to potential Salmonella contamination. The affected product was distributed across all U.S. states.
Walnut Creek Chocolate Co Inc is recalling Peanut Butter Fudge packaged in 8-ounce tubs, 5-pound loaves, and 4-pound trays due to potential Salmonella contamination. The recalled products were distributed to 29 states.
Walnut Creek Chocolate Co Inc is recalling Milk Peanut Butter Cups due to potential Salmonella contamination. The FDA Class I recall affects 3,276 units distributed across 30 US states.
Walnut Creek Chocolate Co Inc is recalling Jason & Mary Peanut Butter Pretzel Cluster due to potential Salmonella contamination. The recalled product was distributed across 29 states.
Walnut Creek Chocolate Co Inc is recalling Seasonal Peanut Butter Cup Gift Boxes due to potential Salmonella contamination. The 4oz boxes with Lot Code 1362 have been distributed across multiple states.
The JM Smucker Company is recalling 20,021 cases of JIF 340-gram Creamy Peanut Butter due to potential Salmonella contamination. Affected products distributed nationwide should not be consumed; consumers should discard or return them.
Walnut Creek Chocolate Co Inc is recalling 8,139 units of Assorted Chocolate Gift Boxes due to potential Salmonella contamination. The recall affects 30 states.
The JM Smucker Company is recalling JIF Light Creamy Peanut Butter due to potential Salmonella contamination. Affected products were distributed nationwide; consumers should verify lot codes and best-by dates and refrain from consuming the product.
The JM Smucker Company is recalling JIF Natural Creamy Peanut Butter in multiple package sizes due to potential Salmonella contamination. The recall affects 553,007 cases distributed nationwide.
The JM Smucker Company is recalling JIF 40 Ounce Natural Honey due to potential Salmonella contamination. Affected products have lot codes 1274425 or 2140425 with best-by dates from October 2022 to May 2023.
The JM Smucker Company is recalling JIF 1.5 oz and 31.25 gram Creamy Peanut Butter To Go packages due to potential Salmonella contamination. These products were distributed to all 50 states.
Tornier's Ratcheting Screwdriver Handle in the Aequalis Perform Reversed kit cannot meet sterilization requirements when sterilized per instructions in an Aesculap container. The company is recalling 1066 units distributed nationwide.
Becton Dickinson is recalling 199 units of BD Anti-Kappa PE flow cytometry reagent because samples may exhibit uncharacteristic flow profiles that could affect test accuracy.
Busse Hospital Disposables is recalling CVC Dressing Change Kits nationwide due to uncertainty about test method validation during manufacturing. Affected swab products may not have been adequately validated for sterility and efficacy.
Direct Rx is recalling 81 bottles of Losartan Potassium and Hydrochlorothiazide 100/12.5 mg due to AZIDO impurity exceeding acceptable manufacturing standards. Affected bottles were distributed in Alabama, Georgia, Florida, and Louisiana.
Nephron Sterile Compounding Center is recalling Phenylephrine HCl Injection syringes nationwide due to lack of assurance of sterility affecting 76,860 units.
Busse Hospital Disposables recalls approximately 425 units of its Single Shot Epidural Tray nationwide due to inadequate validation of manufacturing test methods for swab components.
Intuitive Surgical recalls da Vinci Energy SynchroSeal surgical instruments due to potential seal failure. Excessive tissue in the instrument jaws can result in insufficient sealing.
Nephron Sterile Compounding Center is recalling 134,415 pre-filled syringes of Epinephrine Injection due to lack of assurance of sterility. Affected lots were distributed nationwide; patients and providers should contact their healthcare provider.
Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International are being recalled due to uncertainty about manufacturing test method validation.
Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International (PDI) have been recalled due to uncertainty regarding the adequacy of manufacturing test method validation.
Nephron Sterile Compounding Center has recalled 115,640 units of Labetalol HCl Injection due to lack of assurance of sterility. The affected product was distributed nationwide.
The Proteus235 Proton Therapy System may deliver radiation to initial treatment fields with incorrect scanning magnet settings. The radiation field may be smaller than expected and may deliver higher dose than prescribed.
Nephron Sterile Compounding Center recalled Lidocaine HCl Injection due to lack of sterility assurance. The recalled lot affects 65,590 pre-filled syringes distributed nationwide.
Nephron Sterile Compounding Center is recalling 35,850 pre-filled syringes of EPINEPHrine Injection due to lack of sterility assurance. The affected syringes were distributed nationwide.