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.
Certain lots of Thermalon Back Wrap may have been exposed to excessive moisture, potentially resulting in mold and mildew growth. The product is distributed nationwide in the US and Canada.
SCA Pharmaceuticals recalled approximately 8,050 syringes of PHENYLephrine HCl injection nationwide due to lack of assured sterility. Affected lots have expiration dates from November 2023 to June 2024.
Bruder Healthcare Company is recalling 1,416 units of Thermalon Sinus Compress (Item Number 24332) due to potential mold and mildew growth from excessive moisture exposure. Affected lot numbers are M053160 and M053570.
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 recalls 1,023 syringes of Hydromorphone Injection nationwide due to lack of sterility assurance. No illnesses have been reported.
German Home Bakery Apple Coffee Cake is being recalled due to undeclared wheat and Yellow #5 food coloring. Consumers with wheat allergies or Yellow #5 sensitivity should not consume this product.
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.
Baxter Healthcare has added a contraindication to Peri-Guard Repair Patch instructions, restricting use in neurosurgery because endotoxin levels may exceed allowable limits for cerebrospinal fluid-contacting devices.
Boston Scientific recalls certain batches of OptiCross Coronary Imaging Catheters manufactured with an incorrect voltage setting that may cause decreased image brightness.
SCA Pharmaceuticals is recalling Midazolam HCl 100 mg/100 mL injectable nationwide because the manufacturer cannot assure sterility of the product. Users should consult their healthcare provider regarding affected lot numbers.
Medivance Inc. is recalling Neonatal ArcticGel Pads due to reduced water flow that may prevent proper heating or cooling performance in neonatal temperature management systems. No injuries have been reported.
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 1,122 syringes of neostigmine methylsulfate injection nationwide due to inability to assure product sterility. The affected lot is 1223048138 (expiration 1/31/24).
SCA Pharmaceuticals recalls 256 units of HYDROmorphone HCl injection in Grey CADD Cassettes nationwide due to lack of assured sterility. The affected lot is #1223049529 with expiration date 01/03/24.
SCA Pharmaceuticals recalls PHENYLephrine HCl injectable syringes nationwide due to lack of sterility assurance. The recall affects 1,118 syringes across two lot numbers distributed throughout the USA.
SCA Pharmaceuticals recalls fentanyl injection syringes due to concerns about sterility. No illnesses have been reported, but patients and healthcare providers should check if they have products from the affected lot numbers, which expired in December 2023.
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.
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 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 909 syringes of HYDROmorphone HCl 30 mg/30 mL injection nationwide due to lack of assurance of sterility. Patients should not use affected lots and consult their healthcare provider.
Baxter is recalling specific lot codes of Supple Peri-Guard Repair Patch because endotoxin levels may exceed limits for cerebrospinal fluid-contacting devices. The product should not be used in neurosurgery.
Bruder Healthcare Company is recalling Thermalon Eye Compress Item 2434 from certain lots due to potential mold and mildew growth from excessive moisture exposure. Affected products were distributed in the US and Canada.