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.
Alsultan Sweets Mixed Baklava is being recalled because the product contains undeclared milk and wheat allergens. Consumers with allergies should not consume this product.
Pharmacy Innovations is recalling NADH 10MG/ML injectable vials distributed nationwide due to lack of assurance of sterility. FDA inspection revealed insanitary conditions at the facility.
Pharmacy Innovations is recalling Cyclosporine ophthalmic solutions (0.1%, 0.2%, 1%, 2%, and corn-oil-based 1%) due to lack of sterility assurance. FDA inspection found insanitary facility conditions.
Pharmacy Innovations recalls a polyhexamethylene biguanide eye-drop solution nationwide due to insanitary manufacturing conditions. No illnesses have been reported.
Lidl US TRADING is recalling Chef Select 2 Garlic Baguettes (175 g) because they contain undeclared wheat and milk allergens. The product was distributed to stores in VA, MD, NC, GA, SC, PA, NJ, DE, NY, and Washington D.C.
Pharmacy Innovations is recalling Glycerin Sterile 99% Injectable (2ML and 5ML vials) nationwide. FDA inspection revealed insanitary facility conditions that compromise the product's sterility assurance.
Pharmacy Innovations is recalling Mitomycin ophthalmic solutions nationwide due to a lack of sterility assurance. An FDA inspection found insanitary conditions at the manufacturing facility.
The FDA has recalled Methotrexate intravitreal injectable from Pharmacy Innovations due to lack of assured sterility. An FDA inspection revealed insanitary conditions at the manufacturing facility.
Pharmacy Innovations is recalling Clindamycin/EDTA Calcium irrigation solution (30ML syringe) distributed nationwide due to lack of assurance of sterility caused by insanitary conditions found during FDA inspection.
Pharmacy Innovations is recalling 5-Fluorouracil 1% ophthalmic solution nationwide due to lack of sterility assurance. An FDA inspection found insanitary conditions at the manufacturing facility.
Pharmacy Innovations is recalling polidocanol injectable vials nationwide after FDA inspection revealed insanitary conditions at the manufacturing facility that compromised sterility assurance.
CooperVision is recalling MyDay Toric and Reveal 1 Day Toric contact lenses because some may have incorrect power, resulting in poor visual acuity. Consumers using affected lots should stop wearing the lenses and consult their eye care provider.
Pharmacy Innovations recalls multiple injectable estradiol and testosterone products due to insanitary facility conditions that compromise sterility assurance. The products were distributed nationwide.
Pharmacy Innovations recalls two concentrations of atropine sulfate eye drops due to insanitary facility conditions discovered by FDA inspection. The products were distributed nationwide.
An injectable phosphatidylcholine/deoxycholic acid product manufactured by Pharmacy Innovations is being recalled nationwide due to lack of sterility assurance. FDA inspection revealed insanitary conditions at the manufacturing facility.
Pharmacy Innovations recalls Cholecalciferol (Vitamin D3) 100,000U/ML Injectable nationwide due to insanitary conditions at the manufacturing facility that compromise product sterility assurance.
Pharmacy Innovations is recalling three injectable vitamin B-complex products nationwide due to insanitary conditions discovered during FDA inspection. The products lack assurance of sterility and may pose contamination risk.
Woodland Foods LLC is recalling D'allesandro and Woodland Foods brand Hickory Smoked Almonds because the packaging fails to declare milk, a major allergen. The recall affects approximately 2,535 lbs distributed nationwide.
Pharmacy Innovations is recalling Methylcobalamin injectable solutions (1MG/ML, 3MG/ML, 5MG/ML vials) distributed nationwide. FDA inspection revealed insanitary conditions at the facility affecting product sterility assurance.
Abbott Molecular is recalling 918 Alinity m nucleic acid testing systems due to three identified potential calibration and configuration errors.
Medline Industries is recalling 1,050 kits of Centurion Medical Products Silver Antimicrobial VAD Drive due to expired components. Affected kits were distributed across New York, Indiana, Florida, New Jersey, and Illinois.
Pharmacy Innovations is recalling multiple testosterone injectable and ophthalmic formulations nationwide due to insanitary facility conditions that prevent assurance of sterile manufacturing.
Agfa Healthcare has recalled XERO Viewer imaging software due to a software defect that can cause issues with images. The defect affects approximately 110 units distributed across the US and 19 other countries.
Pharmacy Innovations is recalling Edetate Disodium 1% ophthalmic solution nationwide due to insanitary facility conditions that compromised sterility assurance. No illnesses have been reported.
Nephron Pharmaceuticals recalls approximately 389,730 vials of sterile water for injection nationwide due to potential product carryover from manufacturing deviations. No illnesses have been reported.