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.
Otis McAllister recalls Emerald River Premium Thai Jasmine Rice due to glass contamination. The product was distributed in Utah, Oregon, Texas, and Washington.
SCA Pharmaceuticals is recalling Diltiazem HCl 125 mg Injectable (381 bags) due to lack of sterility assurance. Patients and healthcare providers should not use affected units from lot #1223049625.
Bruder Healthcare Company is recalling Thermalon Stye Compress (Item Number 24352) in certain lots due to potential mold and mildew growth from excessive moisture exposure. No illnesses have been reported.
WS Global Inc is recalling Himalayan Pain Relief Tea nationwide due to undeclared pharmaceutical drugs—Diclofenac and Dexamethasone Acetate—that were not listed on the product label.
Bruder Healthcare Company is recalling 430 units of MediBeads Neck Wrap (Item 34320) because the product may have been exposed to excessive moisture, creating potential for mold and mildew growth. Lot Number M053300, distributed in the US and Canada.
Medical Action Industries is recalling 206,200 IV Start Kits due to saline syringes recalled by the supplier. The affected kits were distributed in Minnesota and North Dakota.
Alcon is recalling bulb irrigation syringes due to potential sterile barrier compromise in surgical procedure packs. Non-sterile syringes may increase infection risk.
Bruder Healthcare is recalling MediBeads King Pad moist heat compresses (item numbers 34120, 34120PM, 34125R) from certain lots due to potential mold and mildew growth from excessive moisture exposure.
Olympus recalled 3,172 UHI-4 insufflation units due to the front panel LED turning off, which causes loss of air supply. All serial numbers nationwide are affected.
SCA Pharmaceuticals is recalling phenylephrine HCl injection syringes nationwide due to inability to assure sterility. Patients using recalled lots should contact their healthcare provider.
SCA Pharmaceuticals is recalling labetalol HCl injection due to lack of sterility assurance. The recall affects 2,458 syringes distributed nationwide.
SCA Pharmaceuticals is recalling fentaNYL 1,250 mcg/25 mL injection syringes due to lack of sterility assurance. The nationwide recall affects 1,259 syringes; patients should contact their healthcare provider.
SCA Pharmaceuticals is recalling 1,425 syringes of HYDROmorphone HCl 6 mg/30 mL due to lack of assurance of product sterility. The affected lots were distributed nationwide.
Puritan Medical Products distributed HydroFlock Sterile Flocked Collection Devices labeled as Part Number 25-3317-H, Lot S1014 that actually contain product code 25-3317-U. Approximately 232,500 units were affected.
Olympus recalls the SOLTIVE Premium SuperPulsed Laser due to non-compliant power cords incompatible with regional electrical outlets. Approximately 203 units were distributed to Australia, Chile, Germany, Hong Kong, Japan, New Zealand, and Singapore.
SCA Pharmaceuticals is recalling HYDROmorphone HCl injectable syringes nationwide due to lack of sterility assurance. The FDA issued this Class II recall affecting multiple lot numbers.
Amneal Pharmaceuticals is recalling Divalproex Sodium Extended-release Tablets 250 mg nationwide due to failed dissolution specifications. The tablets may not dissolve properly, affecting medication effectiveness.
SCA Pharmaceuticals is recalling 368 bags of vancomycin 1.25 g injectable nationwide because the company cannot assure sterility was maintained. The affected lot was distributed across the USA.
SCA Pharmaceuticals is recalling 130 cassettes of a fentanyl-bupivacaine epidural injection distributed nationwide due to lack of assurance of sterility.
Hologic is recalling 684 kits of the Aptima CMV Quant Assay diagnostic test; when used with plasma specimens, the assay may generate error codes that invalidate test results. Lot number 402941 is affected.
SCA Pharmaceuticals is recalling Phenylephrine HCl Injectable (400 mcg/10 mL) distributed nationwide due to lack of sterility assurance. Affected lot numbers have expiration dates through May 2024.
SCA Pharmaceuticals is recalling Phenylephrine HCl injections nationwide affecting approximately 33,000 units due to lack of assurance of sterility.
Nordic Naturals has recalled its Baby's Vitamin D3 dietary supplement liquid due to elevated vitamin D3 levels. The recall affects approximately 5,564 bottles with lot number 234909.
Bio-Rad Laboratories is recalling a diagnostic test kit due to incorrect calibrations and controls that may produce inaccurate test results. Patients and healthcare providers should contact the manufacturer.
Olympus Corporation recalls the SOLTIVE Pro SuperPulsed Laser (TFL-SLS) due to a non-compliant power cord with incompatible plug configurations for the regions where affected units were distributed.