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.
Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 60 mg after an out-of-specification dissolution result at the 12-month stability station.
Daye is recalling 3,074 packs of 18 Coated Regular Tampons because the product lacks 510(k) clearance.
Daye is recalling 3,074 packs of Initiation 36 Coated Super Tampons because the product lacks 510(k) clearance.
Daye is recalling 3,074 packs of its Heavy Flow Bundle because the product lacks 510(k) clearance.
Endo USA is recalling 2,035 cartons of Everolimus tablets 2.5 mg after results came back out of specification for impurity IP-C.
Acme United Corporation is recalling 2,338 boxes of First Aid Only Sting Relief Swabs from one lot over a product mix-up.
Daye is recalling 3,074 packs of Refill 36 Coated Regular Tampons because the product lacks 510(k) clearance.
Daye is recalling 3,074 packs of its Refill 3 Month Trial Tampon Box because the product lacks 510(k) clearance.
Kenvue Brands is recalling 3,816 bottles of Extra Strength TYLENOL 500mg caplets, 24-count, from one lot because of a defective container.
Daye is recalling 3,074 packs of its Initiation 3 Month All in One Bundle because the product lacks 510(k) clearance.
Daye is recalling 3,074 packs of Initiation 18 Coated Regular and 18 Coated Super Tampons because the product lacks 510(k) clearance.
Daye is recalling 3,074 packs of Refill 18 Coated Regular and 18 Coated Super Tampons because the product lacks 510(k) clearance.
Daye is recalling 3,074 packs of the Initiation 3 Month Trial Tampon Box because the product lacks 510(k) clearance.
Daye is recalling 3,074 packs of its Regular Flow Bundle because the product lacks 510(k) clearance.
Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 40 mg after an out-of-specification dissolution result at the 12-month stability station.
Daye is recalling 3,074 packs of its Initiation 3 Month Regular Flow Bundle because the product lacks 510(k) clearance.
Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 20 mg after an out-of-specification dissolution result at the 12-month stability station.
Demers Food Group is recalling 12,962 cases of Scott & Jon's Shrimp Scampi with Linguine because it contains linguine recalled for Listeria monocytogenes and implicated in an ongoing outbreak.
B. Braun is recalling Streamline Bloodline Sets for Dialog because damaged arterial and venous patient connectors may cause micro-air bubbles in the bloodline and air-in-line alarms.
Wegmans Food Markets is recalling its Large Ultimate Plain Cheesecake, 50 oz, because the product contains undeclared pecans.
Reser's Fine Foods is recalling 795 cases of Fresh Creative Foods Basil Pesto Bowtie Pasta Kit for potential contamination with Listeria monocytogenes.
Wegmans Food Markets is recalling its Large Ultimate Strawberry Topped Cheesecake, 58 oz, because the product contains undeclared pecans.
Twin Marquis is recalling 5,080 packages of Thick Shanghai Style Plain Noodle because the product contains undeclared egg, FD&C Yellow 5 and FD&C Yellow 6.
Reser's Fine Foods is recalling 4,770 cases of Fresh Creative Foods Smoked Mozzarella Penne Salad Kit for potential contamination with Listeria monocytogenes.
Sprouts Farmers Market is recalling Smoked Mozzarella Pasta Salad sold at deli counters and in grab-and-go containers because the product may contain Listeria monocytogenes.