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.
StuffbyNainax is recalling MR. 7 SUPER 700000 capsules because FDA analysis revealed the presence of undeclared sildenafil and tadalafil. The FDA has classified this recall as Class I.
Mojo Max Fusion XXX capsules are being recalled because FDA analysis revealed undeclared sildenafil at 13.1 mg per capsule and tadalafil at 13.8 mg per capsule. The FDA has classified this recall as Class I.
Perfect Pasta, Incorporated is recalling Lobster & Crab Ravioli due to undeclared shrimp, crab, lobster, pollock, whiting, and soy. The product was distributed to consignees in Utah only.
123Herbals is recalling Silintan 25-count pill bottles because FDA analysis revealed the presence of undeclared meloxicam. The FDA has classified this recall as Class I.
Juniper Granola is recalling Junebar Peanut Chocolate Chip All Natural Snack Bars because they contain undeclared milk and soy, which pose a risk to consumers with allergies to these ingredients.
Juniper Granola, LLC is recalling Junebar Chocolate Cherry All Natural Snack Bars because they contain undeclared milk and soy, posing a risk to consumers with allergies to these ingredients.
New Life Pharma is recalling one lot of Semaglutide Injection 2 mg sterile multi-dose vials for lack of assurance of sterility.
New Life Pharma is recalling one lot of Tirzepatide Injection 10 mg sterile multi-dose vials for lack of assurance of sterility.
Radnostix is recalling one batch of Sodium Iodide I-131 Therapeutic Oral Solution because of the presence of particulate matter caused by production issues.
Rising Pharma Holding is recalling one lot of Temozolomide Capsules 5 mg after an out-of-specification result was observed during nine-month long-term stability testing.
Olympus is recalling all lots of its Single Use Biopsy Valve, model MAJ-210, because of the potential for rubber fragment detachment during use.
Staar Surgical is recalling seven EVO+ Visian Toric Implantable Collamer Lenses that were labeled as 12.1 mm but are 12.6 mm, creating the potential for excessive vault.
Roche is recalling cobas pro sample supply units on software versions before 03-02 because a defect can make the analyzer repeat the last calculated result for all later measurements.
Olympus is recalling ShockPulse-SE Lithotripsy System reusable probes after further instances of the generator remaining in a blinking phase waiting to recognize the transducer.
Olympus is recalling ShockPulse-SE Lithotripsy System single use probes after further instances of the generator remaining in a blinking phase waiting to recognize the transducer.
B. Braun Medical is recalling 21GA Winged Infusion Sets, model 7M2802, because the needle tip may be dull or blunt, difficult to advance, or may break.
B. Braun Medical is recalling 21G x 4.4 cm Winged Infusion devices, model 7B3050, because the needle tip may be dull or blunt, difficult to advance, or may break.
GE Healthcare is recalling Centricity Universal Viewer Zero Footprint Client because under certain workflows the patient information shown may not match the images displayed.
New Life Pharma is recalling one lot of Tirzepatide Injection 15 mg x 4 sterile multi-dose vials for lack of assurance of sterility.
Teva Pharmaceuticals is recalling six lots of Metoprolol Succinate Extended-Release Tablets 50 mg after the product failed dissolution specifications.
New Life Pharma is recalling two lots of Semaglutide Injection 2 mg x 10 sterile multi-dose vials for lack of assurance of sterility.
Olympus is recalling the ShockPulse-SE Lithotripsy System Generator after further instances of the generator remaining in a blinking phase waiting to recognize the transducer.
Teva Pharmaceuticals is recalling six lots of Metoprolol Succinate Extended-Release Tablets 25 mg after the product failed dissolution specifications.
Teva Pharmaceuticals is recalling three lots of Metoprolol Succinate Extended-Release Tablets 200 mg after the product failed dissolution specifications.
Siemens Healthcare Diagnostics is recalling all lots of the Atellica CH Urine Albumin assay because falsely depressed patient results may occur above the measuring interval.