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.
Fresenius Medical Care is recalling 0.9% Sodium Chloride Injection in flexible plastic containers nationwide due to lack of assurance of sterility. The FDA classified this as a Class II recall.
Advanced Pharmaceutical Technology, Inc. is recalling TESTO-200 (Testosterone Cypionate Injection USP, 200mg/ml) because it was marketed without an approved NDA or ANDA.
Thrive Health Solutions is recalling Tirzepatide Injections (10mg/mL, pre-filled syringes) distributed nationwide due to lack of assurance of sterility. Consumers should not use the affected product and contact their healthcare provider.
Hy-Vee is recalling Duo Spicy Calif Shrimp 10Pc due to potential contamination with Listeria monocytogenes. Affected product was distributed to retail locations throughout the Midwest.
Thrive Health Solutions is recalling Tirzepatide/Cyanocobalamin Injectable 15mg/1mg/mL pre-filled syringes (Lot C03065F) due to lack of assurance of sterility. The product was distributed nationwide in the USA.
Thrive Health Solutions is recalling NAD+ 100mg/mL pre-filled syringes (Lot GA37484) because the manufacturer cannot assure the product is sterile. The product was distributed nationwide.
Target Corporation is recalling Grilled Chicken Greek Style Salad with Balsamic Dressing because the cucumber may be contaminated with Salmonella. The recall affects 220 units distributed in Illinois, Indiana, Tennessee, and Virginia.
Thrive Health and Wellness, LLC is recalling LL Bioboost Injectable pre-filled syringes nationwide due to lack of assurance of sterility. The affected product is Lot #H277639 with expiration 6/25/2025.
Hy-Vee is recalling Duo Crunchy Veg Shrimp 10Pc due to potential contamination with Listeria monocytogenes. The affected product was distributed to retail locations throughout the Midwest.
Hy-Vee is recalling Crispy Shrimp Roll 10Pc due to potential Listeria monocytogenes contamination. Consumers should not consume the product.
TRI-UNION FROZEN PRODUCTS INC (Chicken of the Sea Frozen Food) is recalling frozen raw peeled and deveined tail-on shrimp because they contain undeclared sulfites, a potential allergen.
Isabelle's Kitchen, Inc. is recalling Mediterranean Pasta Salad due to Salmonella contamination. The affected product was distributed in Pennsylvania and Maryland.
Insulet Corporation is recalling the Omnipod 5 iOS App due to a software issue where decimal separators are not recognized in manual insulin entry, potentially causing insulin overdose and severe hypoglycemia.
Integra LifeSciences is recalling Extended Tip Applicators (15 CM, Box of 5) because they may contain out-of-specification levels of endotoxins and lack sterility assurance.
Thrive Health Solutions is recalling Semaglutide 2.5 mg/mL pre-filled syringes (Lot #H270221) because the manufacturer cannot assure sterility of the product.
Isabelle's Kitchen, Inc. is recalling Maple Avenue Foods Crunchy Wheatberry Salad due to Salmonella contamination. The 5 lb. containers were distributed to Pennsylvania and Maryland.
NatureMills US Incorporated is recalling Nature Mills Garlic Vadam (100g) distributed nationwide via its website because the product contains undeclared wheat allergens.
Barco N.V. is recalling certain NexxisOR system display encoder and decoder models due to duplicate MAC addresses that can cause system malfunction, audio/video interruptions, and delayed procedures when multiple units are deployed together.
NatureMills US Incorporated is recalling Nature Mills Tomato Vadam (100g) because the product contains undeclared wheat allergen. Consumers with wheat allergies risk allergic reaction if they consume the product.
GE Healthcare is recalling the LOGIQ F R3 ultrasound system because it may display previous obstetric patient data in fetal weight measurements, potentially leading to incorrect clinical decisions about fetal size and growth.
NatureMills US Incorporated is recalling Nature Mills Wonderberry Leaf Soup because it contains undeclared wheat allergen. Consumers with wheat allergies who purchased this product should not consume it.
NatureMills US Incorporated is recalling Nature Mills Rice Papad (200g) because the product contains undeclared wheat allergens. Consumers with wheat allergies should not consume the affected product.
Limacorporate is recalling PRIMA 2MM Eccentrical Adaptor With Screw sterile devices because the black laser marking used to identify position may be missing.
Becton Dickinson is recalling BD Insyte Autoguard Winged Shielded IV Catheters (Lot# 4282308) because the catheter needle may be slow to retract or fail to retract entirely following use.
NatureMills US Incorporated is recalling Nature Mills Horsegram Soup 100g packets because they contain undeclared wheat, a major allergen. The product was distributed nationally via the company's website.