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.
New Spirit Naturals is recalling 37 containers of Ultra Whey Protein Powder because the product contains undeclared milk.
Egress Capital Partners is recalling 3,547 cases of Taproom Gourmet 15 lb bulk Broadway Mix because the product has no ingredient label and contains undeclared peanuts, sesame, wheat and soy.
GenoGenix is recalling Low Solubility Peptide Reconstitution Solution for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
Major Pharmaceuticals is recalling 866 blister packs of Chlorpromazine Hydrochloride Tablets USP 100 mg because N-Nitroso Desmethyl Chlorpromazine was present above the recommended intake limit.
GenoGenix is recalling Calcium Chloride for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
Demers Food Group is recalling 966 cases of Scott & Jon's Honey Sesame Salmon Rice Bowl because the product contains undeclared wheat.
Applied Medical Technology is recalling 840 NutraGlide 5 F - 8 F x 55 nasal feeding tubes whose distal tips may detach at lower than expected forces.
Toto Foods is recalling 120,180 Toto S'Mores Ooey Gooey Cookies because the label contains conflicting statements about whether the product contains soy.
GenoGenix is recalling Pentosan for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
Major Pharmaceuticals is recalling 2,064 fifty-tablet blister packs of Chlorpromazine Hydrochloride Tablets USP 25 mg because a nitrosamine impurity exceeded the recommended intake limit.
Major Pharmaceuticals is recalling 506 blister packs of Chlorpromazine Hydrochloride Tablets USP 50 mg because N-Nitroso Desmethyl Chlorpromazine was present above the recommended intake limit.
GenoGenix is recalling Glycine for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Epithalon for Injection, 20mg, in all presentations from a single lot for lack of assurance of sterility.
GenoGenix is recalling L-Arginine for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
Major Pharmaceuticals is recalling 1,256 blister packs of Chlorpromazine Hydrochloride Tablets USP 25 mg because N-Nitroso Desmethyl Chlorpromazine was present above the recommended intake limit.
Organicare Nature's Science is recalling 15,075 bottles of FemiClear Daily Bladder Strength for microbial contamination with Escherichia coli O7:K1 and E. coli 1303.
GenoGenix is recalling Retatrutide for Injection, 60mg/10mL vial, from a single lot for lack of assurance of sterility.
GenoGenix is recalling Sterile Saline Reconstitution Solution for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling NAD+ injection at 50 mg/mL and 100 mg/mL in 10 mL multi-dose vials, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling preserved Ascorbic Acid (Vitamin C) for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
Gansu Zhaofeng Agricultural Development is recalling 42,552 bags of G&L Food Dried Bean Curd distributed in California because of undeclared wheat.
GenoGenix is recalling Elite Stack Reconstitution Solution for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
New Spirit Naturals is recalling 178 containers of Super Muscle Support Powder because the product contains undeclared milk.
GenoGenix is recalling Methylene Blue for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
Acuity Specialty Products is recalling Wyandotte Sanifect E3 ethanol-based hand sanitizer because required receipt testing of incoming alcohol was not performed, so methanol risk could not be excluded.