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.
Sandoz Inc is recalling Enoxaparin Sodium Injection (batch SAH06821A) nationwide due to CGMP deviations: products were exposed to temperatures outside labeled storage conditions, potentially affecting drug stability.
Cardinal Healthcare is recalling Asmanex Twisthaler inhalers (batch U027458) because they were exposed to temperatures outside their labeled storage conditions. The FDA classified this as a Class II recall due to the manufacturing deviation.
Cardinal Healthcare is recalling Allopurinol 300 MG tablets (batch L100813) nationwide because products were exposed to temperatures outside their labeled storage conditions. Patients should consult their healthcare provider.
Cardinal Healthcare is recalling Citalopram 20mg tablets (batch 3131748) nationwide due to exposure to temperatures outside labeled storage conditions during manufacturing.
Jardiance 25 mg tablets distributed nationwide were recalled due to CGMP deviations where products were exposed to temperatures outside the labeled storage conditions. The recall affects batch D41919.
Cardinal Healthcare is recalling Meloxicam 15 mg tablets nationwide due to exposure to temperatures outside labeled storage conditions. No adverse events have been reported.
Certain Liberty Select Cycler hemodialysis machines may display an incorrect timestamp on treatment data reports sent to clinics. No injuries or illnesses have been reported.
Propranolol Hydrochloride tablets have been recalled nationwide. Products were exposed to temperatures outside labeled storage conditions during manufacturing, potentially affecting drug stability.
Cardinal Healthcare is recalling Fluticasone Propionate Nasal Spray (50MCG per spray) due to CGMP deviations where products were exposed to temperatures outside labeled storage conditions. Nationwide distribution affected.
Cardinal Healthcare is recalling Chlorthalidone Tablets, 25mg (Batch 2107329UM) distributed nationwide because products were exposed to temperatures outside the labeled storage conditions.
Cardinal Healthcare is recalling Dicyclomine Hydrochloride 20 mg tablets due to temperature exposure outside labeled storage conditions. No illnesses have been reported.
Cardinal Healthcare is recalling Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg, 18-tablet cartons) nationwide because products were exposed to temperatures outside the labeled storage conditions. Batch P125514 is affected.
CARDINAL HEALTHCARE is recalling Amoxicillin for Oral Suspension nationwide due to CGMP deviations. Products were exposed to temperatures outside their labeled storage conditions.
SPIRIVA (tiotropium bromide) inhalation powder batch 104440 is being recalled nationwide due to exposure to temperatures outside the product's labeled storage conditions during manufacturing.
Cardinal Healthcare recalls albuterol sulfate inhalation aerosol batch MY7E nationwide due to exposure to temperatures outside labeled storage conditions. The precautionary recall affects 2 cartons.
Colgate Total SF Toothpaste (Batch 1293US561C, 4.8 oz, Clean Mint) distributed nationwide is being recalled due to CGMP deviations where products were exposed to temperatures outside labeled storage conditions.
Cardinal Healthcare is recalling Terconazole Vaginal Suppositories (batch 1014228A) distributed nationwide because products were exposed to temperatures outside the labeled storage conditions.
Steris Corporation recalls Medivators Advantage endoscope hookup accessories because identification labels become illegible as ink degrades, potentially preventing proper hookup identification and delaying patient procedures.
Wakefern Foods Corp. is recalling Bowl & Basket Zero Calorie with Sucralose Sweetener due to undeclared aspartame and missing phenylalanine warning. The product poses a risk to consumers with phenylketonuria (PKU).
Rong Shing Dried Peach (6 oz) is recalled because it contains undeclared cyclamate, an artificial sweetener not approved for use in the United States. The product was distributed in New York and Texas.
Cardinal Healthcare is recalling Doxycycline 100 mg Capsules nationwide due to exposure to temperatures outside labeled storage conditions. No illnesses have been reported.
Lillow oral contraceptive tablets (batch A5921) have been recalled nationwide by Cardinal Healthcare due to exposure to temperatures outside labeled storage conditions.
Cardinal Healthcare is recalling Aripiprazole 5 mg tablets nationwide due to CGMP deviations. Products were exposed to temperatures outside labeled storage conditions. No illnesses have been reported.
Cardinal Healthcare recalls Folic Acid tablets (1mg, batch H08221) nationwide due to storage temperature deviations during manufacturing. No illnesses reported.
ARMOUR THYROID 120 mg tablets in batch W05543 are being recalled nationwide due to exposure to temperatures outside the labeled storage conditions. No illnesses or injuries have been reported.