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 recalls Pantoprazole Sodium oral suspension nationwide due to product discoloration. Lot MHC1317A with approximately 14,064 units was distributed in the USA.
Eye surgery convenience kits containing 3M surgical drapes that were separately recalled are being recalled. Affected units were distributed in LA, MO, NC, and FL.
ROi CPS LLC is recalling 20 surgical convenience kits distributed in LA, MO, NC, and FL because they contain 3M surgical drapes that were subsequently recalled.
ROi CPS LLC is recalling 258 surgical convenience kits containing 3M surgical drapes that were subject to a subsequent recall. The kits were distributed in Louisiana, Missouri, North Carolina, and Florida.
Endo-Therapeutics is recalling 28 eSuction Small Cavity Model ET2005 devices distributed in Florida and Pennsylvania due to improper regulatory classification.
ROi CPS LLC is recalling Regard hip arthroscopy surgical convenience kits containing 3M surgical drapes that were subsequently recalled. The kits were distributed in LA, MO, NC, and FL.
ROi CPS LLC is recalling 243 surgical convenience kits that contain recalled 3M surgical drapes. The kits were distributed in four states.
ROi CPS LLC is recalling 18 regard KYPHOPLASTY surgical convenience kits that contained recalled 3M surgical drapes. The kits were distributed to medical facilities in Louisiana, Missouri, North Carolina, and Florida.
ROi CPS LLC is recalling 228 gastric surgery convenience kits because they contained 3M surgical drapes that were subsequently recalled. The affected kits were distributed in LA, MO, NC, and FL.
ROi CPS LLC is recalling 738 regard CATARACT eye surgery convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida because they contain 3M surgical drapes that have been recalled.
Acella Pharmaceuticals is recalling Phenytoin Sodium Injection because the primary vial label is missing a barcode. The recall affects 637 cartons distributed nationwide.
Acella Pharmaceuticals is recalling Phenytoin Sodium Injection due to missing barcodes on vial labels. The recall affects 574 cartons distributed nationwide.
Adam's Polishes ALCOHOL BASED HAND SANITIZER (multiple sizes) is recalled nationwide because FDA analysis found methanol contamination. This Class I recall poses a serious chemical health risk.
Zingerman's Creamery is recalling Harvest Pumpkin Gelato due to undeclared egg allergen. The recall affects pints and quarts distributed in Michigan.
Zingerman's Creamery is recalling Paw Paw Gelato in pint (16 oz) and quart (32 oz) sizes due to undeclared egg. Consumers with egg allergies should not consume this product.
Insulet Corporation is recalling the Omnipod Dash PDM remote controller for insulin pumps due to battery defects causing overheating, swelling, and fire hazard. A fire incident has been reported.
Abbott Laboratories is recalling Pedialyte Unflavored Electrolyte Solution 2 fl oz bottles due to compromised seal integrity that could lead to spoilage. The recall affects 14,588,544 bottles distributed in the US and internationally.
Healthcare sterilization containers failed aerosol challenge testing, indicating potential inadequate sterilization of surgical instruments. 493 units affected across US and international markets.
Abbott Laboratories is recalling Similac 360 Total Care Sensitive infant formula due to compromised seal integrity that could lead to spoilage. Affected consumers should not use the product and contact Abbott for further instructions.
CareFusion Genesis sterilization containers failed to meet aerosol challenge testing requirements and may not properly sterilize medical instruments.
DeVilbiss is recalling 125 series iGO2 oxygen concentrators due to an unapproved adhesive in the accumulator tank, which is part of the oxygen delivery system. Affected units were distributed in eight U.S. states and Canada.
BD Phoenix PMIC/ID-107 diagnostic panels contain misformulated minocycline that may produce false antibiotic resistance results, potentially delaying appropriate patient treatment.
CareFusion's Genesis sterilization containers failed to meet FDA aerosol challenge testing requirements, affecting 895 units distributed in the US and internationally. Proper container function is essential to ensure medical instruments are adequately sterilized.
The Philips Laser System (REF: LAS-100) may experience system failures (Error 106 or 108) that prevent further treatment during cardiac procedures.
Par Pharmaceutical is recalling Phenoxybenzamine Hydrochloride Capsules 10mg nationwide due to failed impurity and degradation specifications. The recalled lot may not meet pharmaceutical quality standards.