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.
Levothyroxine Sodium Tablets, USP 175 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 2,344 bottles affected.
YoCrunch Low Fat Yogurt with Toppers, Vanilla with Chocolate Chip Cookie Dough pieces multipacks, is being recalled because of foreign material in the form of plastic pieces.
YoCrunch Lowfat Yogurt with Toppers two-product packages containing vanilla yogurt with M&Ms and with Oreo pieces are being recalled because of foreign material in the form of plastic pieces.
Levothyroxine Sodium Tablets, USP 25 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 82,159 bottles affected.
Lisinopril and Hydrochlorothiazide Tablets 20 mg/12.5 mg are being recalled after a complaint that a sealed bottle contained a foreign tablet identified as atazanavir and ritonavir. 58,968 bottles affected.
Levothyroxine Sodium Tablets, USP 25 mcg in 1000-count bottles from Accord Healthcare are being recalled because the product is subpotent. 2,352 bottles are affected.
Chocolate Crunch Cake Bar frozen stick novelties are being recalled because of potential Listeria monocytogenes contamination. The action covers 110,292 cases across all affected products.
Levothyroxine Sodium Tablets, USP 112 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 4,896 bottles affected.
A YoCrunch Lowfat Yogurt with Toppers two-product package containing strawberry and raspberry yogurt with granola is being recalled because of foreign material in the form of plastic pieces.
Omeprazole Delayed-release Capsules USP 20 mg are being recalled because a foreign Divalproex Sodium Extended-Release 250 mg tablet was found in a bottle. 1,476 bottles affected.
Fudge Frenzy Bar frozen stick novelties are being recalled because of potential Listeria monocytogenes contamination. The action covers 110,292 cases across all affected products.
YoCrunch Low Fat Yogurt with Toppers, Vanilla with Twix bar pieces, is being recalled because of foreign material in the form of plastic pieces.
Rizatriptan Benzoate Tablets USP 10 mg are being recalled after detection of N-nitroso-dimethyl-rizatriptan above the FDA recommended acceptable intake limit.
Orange Cream Bar frozen stick novelties are being recalled because of potential Listeria monocytogenes contamination. The action covers 110,292 cases across all affected products.
The NIO Intraosseous Device Adult is being recalled because a manufacturing error means the built-in stabilizer may not be released properly after deployment and insertion. 516 US units affected.
BLS laser light show projectors, models DIODE 1000, 2000 and 3000, are being recalled because the remote interlock connector required by federal regulation was not installed or was not wired. 10 units affected.
Cotton Candy Twirl Bar frozen stick novelties are being recalled because of potential Listeria monocytogenes contamination. The action covers 110,292 cases across all affected products.
Little Remedies Honey Cough 4 fl oz is being recalled because it is contaminated with Bacillus cereus and may be spoiled. 10,223 cases, or 245,352 units, are affected.
Strawberry Shortcake Bar frozen stick novelties are being recalled because of potential Listeria monocytogenes contamination. The action covers 110,292 cases across all affected products.
Wei-Chuan branded Black Fungus Slice in 2.5 oz bags is being recalled because the wood-ear mushroom tested positive for Salmonella. 100 cases are affected.
EMPOWR 3D Knee Tibial Insert E-PLUS units, catalog number 341-10-711, are being recalled because of a packaging discrepancy in which incorrect tibial inserts were packaged. 20 units affected.
BLS laser light show projectors, models CLUB 1000, 2000 and 4000, are being recalled because the remote interlock connector required by federal regulation was not installed or was not wired. 12 units affected.
YoCrunch Lowfat Yogurt with Toppers two-product packages containing strawberry yogurt with M&Ms and with Oreo pieces are being recalled because of foreign material in the form of plastic pieces.
Access Vitamin B12 Reagent lot 439850 is being recalled after complaints of erroneous results, which may lead to a delayed or improper diagnosis or repeat testing. 10,000 units are affected.
YoCrunch Low Fat Yogurt with Toppers, Strawberry with milk chocolate M&Ms minis, is being recalled because of foreign material in the form of plastic pieces.