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.
GenoGenix is recalling Oxytocin for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Sermorelin lyophilized powder for reconstitution, 10mg in a 10 mL multi-dose vial, from a single lot for lack of assurance of sterility.
GenoGenix is recalling Semaglutide for Injection, 20 mg in 10 mL multi-dose vials, from two lots for lack of assurance of sterility.
Egress Capital Partners is recalling 3,547 cases of Taproom Gourmet 20 lb bulk Park Mix because the product has no ingredient label and contains six undeclared allergens.
ImaCor is recalling 45 ClariTEE miniaturized TEE probes after a production assembly error left articulation reversed, so moving the lever forward anteflexed the tip instead of retroflexing it.
GenoGenix is recalling B12 Hydroxocobalamin for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
FUJIFILM is recalling 16 FDR Visionary Suite systems because the shaft mounting the X-ray tube unit on the support may break, with protective parts possibly not working.
Major Pharmaceuticals is recalling 1,394 blister packs of Chlorpromazine Hydrochloride Tablets USP 200 mg because N-Nitroso Desmethyl Chlorpromazine was present above the recommended intake limit.
GenoGenix is recalling GAC for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Biotin for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Alpha Lipoic Acid for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
Canon Medical Systems is recalling eight radiography/fluoroscopy systems because changing the acquisition program returns the collimator to a default ROI, leaving the X-ray area partially covered by a static image.
GenoGenix is recalling L-Glutamine for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
Applied Medical Technology is recalling 390 NutraGlide nasal feeding tubes whose distal tips may detach at lower than expected forces.
Egress Capital Partners is recalling 3,547 cases of Taproom Gourmet bulk Fifth Avenue Mix because the product has no ingredient label and contains undeclared peanuts, almonds, cashew and soy.
GenoGenix is recalling Lipo MIC + B12 Methylcobalamin for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Amino Blend for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling N-Acetyl-L-Cysteine for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling BPC-157 for Injection, 15mg/10mL vial, from a single lot for lack of assurance of sterility.
GenoGenix is recalling Magnesium Chloride for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Tri-Immune for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
RC Outsourcing is recalling 2,669 prefilled Bevacizumab 1.75 mg/0.07 mL intravitreal syringes for lack of assurance of sterility.
GenoGenix is recalling CoQ10 for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Lipo MIC + L-Carnitine for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
Applied Medical Technology is recalling 1,780 NutraGlide 5 F - 6 F x 55 nasal feeding tubes whose distal tips may detach at lower than expected forces.