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.
Deskins Candies Peanut Butter Fudge is being recalled due to Salmonella contamination in the peanut butter ingredient. The recall affects products distributed to West Virginia, Virginia, and North Carolina.
Garden Cut Celery Bites w/ Peanut Butter may contain Salmonella in the peanut butter component. Affected 6oz packages were distributed in seven states with Best By dates between May 25 and June 3, 2022.
Morski Brands is recalling Marketside Gouda Bacon Green Chile Dip distributed nationwide by Walmart due to potential metal fragments in the product. Consumers should not consume affected units.
GE Healthcare is recalling CARESCAPE Central Station V2 patient monitoring devices due to potential power supply failure that can cause device shutdown and loss of patient monitoring.
Olympus URETERO-RENO FIBERSCOPE Model URF-P6R recalled due to incorrect adhesive securing the diopter ring, which may cause loss of focus and in rare cases urinary tract perforation.
Sun Pharmaceutical is recalling 26,892 vials of medroxyprogesterone acetate injectable suspension (150 mg/mL) distributed nationwide due to lack of assurance of sterility. The affected lots expire between January and June 2023.
Sun Pharmaceutical is recalling 4,625 syringes of Medroxyprogesterone Acetate Injectable Suspension (Lot HAC1951A) due to lack of assurance of sterility. The affected medication was distributed nationwide.
Tandem t:slim X2 insulin pumps may display inaccurate battery levels, risking insulin delivery failure if the battery depletes unexpectedly. Users should maintain battery above 25% to prevent unintended insulin cessation.
Cedar Crest Specialties, Inc. is recalling Cedar Crest WI Campfire S'Mores Ice Cream due to foreign plastic material in the product. Consumers should not consume the affected product.
Afaxys Pharma is recalling 79,339 prefilled syringes of medroxyprogesterone acetate because the manufacturer could not assure sterility. The syringes were distributed nationwide.
Illumina is recalling approximately 1,014 MiSeq Dx sequencing instruments due to a cybersecurity vulnerability. The devices are distributed worldwide and throughout the United States.
Cedar Crest Caramel Collision Ice Cream is being recalled due to the presence of plastic foreign material in the product. The affected product was distributed across IL, MI, MN, TX, and WI.
Washington Homeopathic Products recalled Bacillinum Pulmo homeopathic drug due to manufacturing practice deviations. The Class II recall, initiated in May 2022 and terminated in May 2023, affected nationwide distribution.
A.P. Nonweiler is recalling its 80% alcohol antiseptic hand sanitizer because FDA testing found acetaldehyde and acetal above safe specification limits. The product was distributed in Wisconsin and Virginia.
Soul Cedar Farm's Zesty Sweet Peppers are being recalled due to potential contamination with Clostridium botulinum. Testing found a pH level of 5.57, which can support dangerous pathogen growth in shelf-stable foods.
Medtronic is recalling Cobalt and Crome ICDs and CRT-Ds due to a software telemetry error in the CareLink SmartSync Device Manager. The error may affect device communication and remote monitoring.
Volcano Corp is recalling 11 Philips OmniWire Pressure guide wires distributed in Washington, Wisconsin, and Canada due to a potential failed sterilization process.
Morski Brands recalls 1,312 units of Dawn's Campfire BBQ Beans nationwide due to metal foreign objects. Consumers should not consume the product.
Sun Pharmaceutical is recalling medroxyprogesterone acetate injectable suspension (150 mg/mL) nationwide due to lack of assurance of sterility. Affected lots contain vials with expiration dates from December 2022 through September 2023.
Abbott Laboratories recalls one lot of Pedialyte Strawberry Lemonade powder because dextrose derived from wheat was not declared on the label. Lot code 287112S00.
Morski Brands recalls Ranch BLT Pasta Salad nationwide due to possible metal fragments. The product was sold under Finest Traditions and Dawn's brands with a best-before date of 6-13-22.
Olympus endoscopes with defective diopter ring adhesive may cause vision loss and, in rare cases, urinary tract perforation.
Washington Homeopathic Products is recalling Proteus homeopathic remedy in multiple potencies due to manufacturing process deviations. The firm initiated this voluntary recall in May 2022.
Morski Brands is recalling Steakhouse Potato Salad products nationwide due to metal contamination. Affected brands include Finest Traditions and Dawn's.
Thistle Health Inc. recalls 1,003 bottles of Thistle Tropical Limeade due to strawberries potentially contaminated with Hepatitis A. Affected product was distributed in California, Nevada, Oregon, and Washington.