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.
Trader Joe's is recalling Cilantro Salad Dressing (SKU 36420) due to possible Listeria monocytogenes contamination. Approximately 15,890 cases were distributed nationwide.
Trader Joe's Company is recalling approximately 7,348 cases of Trader Joe's Elote Chopped Salad Kit nationwide due to potential Listeria monocytogenes contamination. All products with "Used By" dates on or before February 18, 2024 are affected.
Micro Labs Limited is recalling 118,080 bottles of Telmisartan 40mg tablets due to failed blend uniformity specifications. The affected lots (SFBG024, SFBG025) were distributed in Puerto Rico, Tennessee, and Rhode Island.
Retractable Technologies is recalling EasyPoint Needles (25G x 5/8", REF: 82091) because the needle cannula may detach from the needle holder inside the patient.
TRP Blur Relief sterile eye drops (Lot #B905) are recalled due to inability to assure product sterility. Approximately 7,248 bottles were distributed nationwide.
Thea Pharma is recalling Betimol (timolol) ophthalmic solution nationwide for lack of sterility assurance and compromised container closure. The defects could allow contamination of the eye medication.
Optikem International is recalling TRP Natural Eyes Floaters Relief eye drops nationwide due to lack of assurance of sterility in manufacturing. Affected bottles have lot numbers F404, F405, or F406.
Optikem International is recalling TRP Natural Eyes Allergy Eyes Relief eye drops due to lack of assurance of sterility. The recall affects 30,240 bottles distributed nationwide.
Baxter Healthcare's Infuvite Adult Multiple Vitamins Injection is being recalled because 70 vials were stored outside their labeled specifications, potentially affecting product stability. The affected vials were distributed to three direct accounts in Arizona, New Mexico, and Utah.
TRP Natural Eyes Aging Eye Relief eye drops are being recalled because the manufacturer cannot assure the product meets sterility requirements. The recall affects 19,344 bottles distributed nationwide.
Optikem International recalls TRP Eye Strain Relief eye drops nationwide due to lack of assurance of sterility. Affected units are 10 mL bottles with Lot E206.
Shimadzu has recalled the Trinias Digital Angiography System due to a capacitor manufacturing issue that could cause abnormal display or system malfunction. No injuries have been reported.
House of Coffee Beans, Inc is recalling coffee products distributed in Texas, South Carolina, and North Carolina due to potential cross-contact with almonds, pecans, and coconut. Consumers with allergies to these ingredients should not consume affected products.
Mckesson is recalling Bicillin L-A prefilled syringes stored outside label specifications. The FDA Class II recall affects 70 vials distributed to direct accounts in NM, AZ, and UT.
Waldemar Link is recalling SPII Model Lubinus Long Stem Prosthesis XL Neck implants due to carton labeling that could be misinterpreted during surgery. Clearer guidance is being provided to prevent surgical misapplication.
Eugia US LLC is recalling 1,160 vials of Tobramycin for Injection due to failed water determination testing. Affected lot numbers are 3TB23001 and 3TB23002, expiring 04/30/2025.
Peter Lazic GmbH's D-Clip Standard/Mini Applier is being recalled after a customer complaint that the device failed to release the clip during surgery, with the applier remaining attached to the clip.
Biosense Webster is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths after inadvertently mixing unvalidated devices into production. The recall affects 853 units distributed nationwide.
B. Braun Medical is recalling 22,752 bags of Potassium Chloride for Injection Concentrate nationwide due to pinholes in container bags that compromise sterility assurance. Affected lots are J2S007 (expires 12/31/2024) and J3A115 (expires 01/31/2025).
The Perfect Bite Co. is recalling Mexican Street Corn Bites due to possible Listeria monocytogenes contamination. The product was distributed in California and Washington.
Siemens Healthcare's ADVIA Centaur EPO Assay (lots 53984040, 55443042) produces readings 35% lower than the WHO standard, failing to achieve its claimed reference interval. No illnesses reported, but diagnostic inaccuracy poses risk of wrong clinical decisions.
KALO Chocolate Cake packages contain carrot cake with undeclared soy not listed on the label. Consumers with soy allergies are at risk of allergic reaction.
A surgical clip applier from Peter Lazic Gmbh has been recalled after a reported failure to release the clip during surgery. The applier remained attached to the clip, potentially posing a safety risk during medical procedures.
Vitony Bakery is recalling Bizcocho de Queso y Guayaba cheese-guava cake for undeclared FD&C Yellow #5 and Yellow #6 dyes. About 6,706 units were distributed in Puerto Rico.
Medline Industries is recalling CVS Health Waterproof Wound Tracking Dressing (REF CVS690330) due to sterility failure. The non-sterile dressings may introduce infection risk when applied to wounds.