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 is recalling approximately 1220 bottles of Zolpidem Tartrate Extended-Release 6.25 mg tablets distributed nationwide due to microbial contamination detected in manufacturing equipment.
Philips Achieva 3.0T MRI systems have an incorrect electrical warning label on the liquid cooling cabinet, missing the high voltage symbol and proper yellow background. This presents a risk of electrical shock to service personnel.
Herold Salads, Inc. is recalling potato salad products in 1lb, 2lb, 5lb, and 10lb tubs due to potential Listeria monocytogenes contamination. The recall affects products distributed in Ohio, Pennsylvania, and Michigan.
Herold Salads, Inc. is recalling Herold's Salad Shell Macaroni Salad in 1lb, 2lb, and 5lb containers due to potential Listeria monocytogenes contamination. The affected product was distributed in Ohio, Pennsylvania, and Michigan.
Herold Salads, Inc. is recalling Black Bean and Corn Salsa due to potential contamination with Listeria monocytogenes. Affected products were distributed in Ohio, Pennsylvania, and Michigan.
ROi CPS LLC is recalling 345 units of regard Operative LAP surgical convenience kits distributed in Louisiana because they were manufactured with a component that was subsequently recalled by Nurse Assist.
Herold Salads is recalling Rainbow Rotini salad packages in 1lb, 2lb, and 5lb sizes due to potential contamination with Listeria monocytogenes. The affected products were distributed in Ohio, Pennsylvania, and Michigan.
Herold Salads, Inc. is recalling Greek Gemelli Pasta Salad due to potential Listeria monocytogenes contamination. The recall affects products distributed in Ohio, Pennsylvania, and Michigan.
Herold Salads, Inc. recalls Amish Wedding Southern Potato Salad with egg due to potential Listeria monocytogenes contamination. Affected products were distributed in Ohio, Pennsylvania, and Michigan.
Herold Salads recalls Amish Wedding - Southern Macaroni Salad for potential Listeria monocytogenes contamination. Distributed in Ohio, Pennsylvania, and Michigan.
Herold Salads is recalling macaroni salad in multiple sizes due to potential Listeria monocytogenes contamination. Affected products were distributed in Ohio, Pennsylvania, and Michigan.
Cleveland's Own Macaroni Salad sold in 5-pound and 10-pound containers is being recalled due to potential Listeria monocytogenes contamination. The recall affects products distributed in Ohio, Pennsylvania, and Michigan.
NBRBDR Inc. is recalling Zucchini Mushroom Pie (5 oz) due to undeclared allergens: egg, milk, and wheat. Consumers with allergies to these ingredients should not consume the product.
Pfizer is recalling 34,000 cartons of 4.2% Sodium Bicarbonate Injection nationwide due to glass particles in the solution. Patients should immediately stop use and contact their supplier.
Herold Salads, Inc. is recalling Health Salad products distributed in Ohio, Pennsylvania, and Michigan due to potential contamination with Listeria monocytogenes.
Maquet Cardiovascular is recalling Express chest drain units with defective sterile water syringes. If not kept upright, patients risk exposure to infectious material that may cause infection, abscess, sepsis, or death.
Herold's Salads Southern Potato Salad with egg is being recalled due to potential Listeria monocytogenes contamination. The recall affects products distributed in Ohio, Pennsylvania, and Michigan.
Herold Salads, Inc. is recalling Cleveland's Own - Original Potato Salad due to potential Listeria monocytogenes contamination. The affected product was distributed in Ohio, Pennsylvania, and Michigan.
Herold Salads is recalling Southern Potato Salad in multiple sizes sold in Ohio, Pennsylvania, and Michigan due to potential Listeria monocytogenes contamination. Consumers should not consume affected products.
Mead Johnson is recalling Enfamil Nutramigen Hypoallergenic Infant Formula Powder due to potential Cronobacter sakazakii contamination. Approximately 1.4 million cans with specific UPC codes (300871239418 or 300871239456) and January 1, 2025 use-by date are affected.
Americaine benzocaine 20% topical anesthetic spray is being recalled nationwide due to benzene chemical contamination. The recall affects 34,704 cans with lot number 1A16420 and expiration date 01/31/2025.
Old Spice Sweat Defense Ultimate Captain anti-perspirant spray is being recalled due to benzene contamination. The FDA Class I recall affects products distributed nationwide and internationally.
The FDA is recalling Secret Dry Spray antiperspirant (Lot #12001458SF) due to benzene contamination. Consumers should stop using the product immediately.
CF Dallas LLC is recalling fresh-cut fruit products because they were made from cantaloupe potentially contaminated with Salmonella. The 27,998 units affected were distributed to retailers in ten states.
Herold Salads is recalling Rotini Garden Medley packaged salad due to potential Listeria monocytogenes contamination. Affected products were distributed in Ohio, Pennsylvania, and Michigan.