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.
Rapidol Triple Antibiotic First Aid Ointment (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate) distributed in Delaware and North Carolina is being recalled for CGMP deviations. The manufacturer initiated a voluntary recall of 9,336 tubes.
Frobright Salsary, LLC is recalling San Juan Traditional Salsa due to potential contamination with wood particles. The 14 oz refrigerated salsa products were distributed in Alaska, Idaho, Oregon, and Washington.
Maximum Security Anticavity Gel Toothpaste (Sodium Fluoride 0.22%, Fresh Mint) distributed in Delaware and North Carolina is being recalled due to CGMP deviations identified by the manufacturer.
Kenil Healthcare is recalling 10,000 tubes of Rapidol Maximum Strength Hydrocortisone 1% Anti-Itch Cream (2 oz, Lot SP26A, Expiration 09/30/2026) distributed in Delaware and North Carolina due to manufacturing quality issues.
KVK Tech, Inc. is recalling 9,680 bottles of Phentermine Hydrochloride Capsules 30mg nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall is voluntary and firm-initiated.
KVK Tech, Inc. is recalling Indomethacin Extended-Release Capsules USP, 75 mg (Lot #18400A) nationwide due to cGMP deviations. The recall affects approximately 9,107 bottles distributed nationwide.
KENIL HEALTHCARE PRIVATE LIMITED is voluntarily recalling Nature Mint Anticavity Fluoride Toothpaste due to Current Good Manufacturing Practice (CGMP) deviations. The affected toothpaste was distributed in Delaware and North Carolina.
KENIL HEALTHCARE PRIVATE LIMITED is recalling Nature Mint Anticavity Fluoride Toothpaste due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 19,500 tubes distributed in Delaware and North Carolina.
Philips is recalling SmartPath to dStream for XR and 3.0T medical imaging software due to potential alignment errors in cross reference line functionality when reviewing images with the MobiView application.
Philips is recalling certain Ingenia Ambition S MRI devices due to potential alignment errors in the cross reference line functionality when reviewing images with the MobiView application.
Philips is recalling MR 5300 medical devices (Model Numbers 782110 and 782152) due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Frobright Salsary, LLC is recalling San Juan Salsa Hot Salsa (14 oz, UPC 1 18738 54634) distributed in Alaska, Idaho, Oregon, and Washington due to potential contamination with wood particles.
Cook Incorporated is recalling Check-Flo Performer Introducer devices (10.0Fr) because affected units may contain an incorrectly sized introducer sheath, which could compromise proper device function.
Frobright Salsary, LLC is recalling Mens Room Roasted Red Salsa (13 oz containers) due to potential contamination with wood particles. The product was distributed in AK, ID, OR, and WA.
Pharmadel LLC is recalling CURA HONGOS 1% Clotrimazole topical lotion due to Current Good Manufacturing Practice (CGMP) deviations identified during production. The voluntary recall affects approximately 10,128 bottles distributed in Delaware and North Carolina.
Philips is recalling certain SmartPath to dStream 1.5T medical imaging devices due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Philips is recalling Ingenia 1.5T MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images with the MobiView application.
Philips has recalled specific Ingenia Elition X MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
KENIL HEALTHCARE PRIVATE LIMITED is recalling KOFAL Original Penetrating Pain Relieving Ointment (methyl salicylate 12%) due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 16,248 jars distributed in Delaware and North Carolina.
Optim V Anti-Itch Cream (Benzocaine 20% & Resorcinol 3%) is being recalled because the manufacturer did not follow current good manufacturing practice (CGMP) standards. The voluntary recall affects 6,372 tubes distributed in Delaware and North Carolina.
Philips is recalling the Ingenia 1.5T S magnetic resonance imaging (MRI) system due to potential alignment errors in cross reference line functionality when reviewing images generated with the MobiView application.
KENIL HEALTHCARE PRIVATE LIMITED is recalling Maximum Security Anticavity Gel Toothpaste sachets distributed in Delaware and North Carolina due to Current Good Manufacturing Practice (CGMP) deviations identified by the FDA.
Nature Mint Anticavity Fluoride Toothpaste (0.76% sodium monofluorophosphate, 2.75 OZ tube) is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The affected lots were distributed in Delaware and North Carolina.
KENIL HEALTHCARE PRIVATE LIMITED is recalling Nature Mint Anticavity Fluoride Toothpaste (0.85 oz tubes) distributed in Delaware and North Carolina due to Current Good Manufacturing Practice (CGMP) deviations.
Philips is recalling the Ingenia 3.0T CX MRI system due to potential alignment errors in the cross reference line when using the MobiView application to review images. The alignment error could affect image accuracy during review.