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.
Accord Healthcare is recalling Simvastatin 80 mg tablets due to manufacturing practice deviations discovered during an FDA inspection. Approximately 205,631 bottles are affected across the US, Puerto Rico, and Canada.
Safe + Fair Food Company's Key Lime Pie Drizzled Popcorn is being recalled due to the potential presence of undeclared peanut residue. Consumers with peanut allergies should not consume this product.
Accord Healthcare recalls Tadalafil 20 mg tablets due to CGMP deviations identified during FDA inspection. Approximately 613,553 bottles distributed in the US, Puerto Rico, and Canada are affected.
Nephron Sterile Compounding Center is recalling Norepinephrine Bitartrate injection nationwide due to lack of sterility assurance. The recall affects 305,895 bottles across 13 lots.
Snack Innovations Inc. is recalling Safe & Fair 7.5 oz drizzled popcorn Honey Crisp Apple Pie due to potential undeclared peanut residue. The product was distributed across multiple U.S. states.
Corim Industries is recalling Agglomerated Peanut Butter Hot Chocolate and Peanut Butter Cappuccino products due to undeclared peanut allergen. People with peanut allergies who consume these products may experience allergic reactions.
Covidien is recalling Monosof nylon sutures due to sterile barrier breach in the breather pouch, which may cause infection or vision loss in ophthalmic procedures. The recall affects 54,288 units distributed nationwide and globally.
Covidien is recalling Surgilon Braided Nylon sutures due to a sterile barrier breach in the breather pouch that could allow bacterial contamination, potentially causing infection or vision loss in ophthalmic procedures.
Beaver Visitec International recalls Ultracell Wick with 80cc Collection Bag due to packaging with potentially open seals that may compromise product sterility. The recall affects 4,640 units distributed across the United States and internationally.
Accord Healthcare is recalling Glimepiride 1 mg tablets distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice deviations discovered during an FDA inspection. The recall affects 469,944 bottles.
Carestream Health is recalling certain DRX-Compass/DR-FIT X-ray systems because the overhead tube crane may unexpectedly continue moving after Z-axis motorized buttons are pressed and released, potentially causing injury.
Accord Healthcare recalls Glycopyrrolate Injection USP following FDA inspection identifying manufacturing deviations. Approximately 23,814 vials distributed to the US, Puerto Rico, and Canada are affected.
Nephron Sterile Compounding Center is recalling Diltiazem HCl injectable due to lack of sterility assurance. The FDA Class II recall affects 4,743 bottles distributed nationwide.
Accord Healthcare is recalling Pravastatin Sodium 20 mg tablets following an FDA inspection that identified manufacturing practice deviations. Approximately 32,688 bottles were distributed in the United States, Puerto Rico, and Canada.
FDA recalls norepinephrine bitartrate injection (270,291 bottles nationwide) due to lack of sterility assurance. The injectable medication from Nephron Sterile Compounding Center poses infection risk if used.
Accord Healthcare is recalling Tadalafil 2.5 mg tablets following discovery of manufacturing deviations during an FDA inspection. Approximately 36,773 bottles were distributed in the United States, Puerto Rico, and Canada.
Accord Healthcare is recalling Pravastatin Sodium 10 mg tablets for CGMP deviations found during FDA inspection. About 9,600 bottles were distributed across the United States, Puerto Rico, and Canada. No illnesses reported.
Accord Healthcare is recalling Aripiprazole 15 mg tablets distributed in the United States, Puerto Rico, and Canada due to Current Good Manufacturing Practice (CGMP) deviations found during an FDA inspection.
Accord Healthcare is recalling Daptomycin for Injection due to manufacturing practice deviations discovered during FDA inspection. No illnesses or injuries have been reported.
Accord Healthcare is recalling 25,344 bottles of Ropinirole 2 mg tablets due to manufacturing deviations discovered during an FDA inspection. The recall affects medications distributed in the United States, Puerto Rico, and Canada.
SCA Pharmaceuticals is recalling 2,125 fentanyl injection syringes nationwide due to subpotency—the product contains less active ingredient than labeled. The firm voluntarily initiated this Class III recall in February 2023.
Accord Healthcare is recalling Dofetilide antiarrhythmic capsules due to manufacturing deviations found during an FDA inspection. The recall involves 37,790 bottles distributed across the United States, Puerto Rico, and Canada.
Accord Healthcare is recalling Rosuvastatin tablets 5mg due to manufacturing practice deviations found during an FDA inspection. The recall involves 63,247 bottles distributed across the U.S., Puerto Rico, and Canada.
Accord Healthcare is recalling Ropinirole 5mg tablets due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection. The recall affects 5,112 bottles distributed in the United States, Puerto Rico, and Canada.
Snack Innovations Inc. is recalling Drizzilicious Mini Rice Cake bites for possible undeclared peanut residue. Consumers with peanut allergies should not consume the product.