The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

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.

1401–1425 of 88106

  • HighFDA (Drugs)·D-0717-2026·2026-07-29

    ROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns

    Rohto-Mentholatum is recalling ROHTO Cooling Eye Drops due to lack of assurance of sterility. The recall affects 499,673 cartons distributed nationwide in the U.S.

    Product
    Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-1177-2026·2026-07-29

    Vintage Roots Root Beer Syrup Recalled Due to Unapproved Sassafras Bark

    Vintage Roots LLC is recalling Vintage Roots Root Beer Syrup because it contains sassafras bark, which is an unapproved food additive.

    Product
    Vintage Roots Root Beer Syrup, packaged in glass bottle. Net Wt. 8oz. (236.6 mL). Distributed by Vintage Roots, PO Box 12, Brady, MT 59416. The product label declares: Ingredients: Filtered Water, Pure Cane Sugar, Sassafras Bark, Burdock Roots, Wild Cherry Bark, Molasses, Fresh…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2790-2026·2026-07-29

    Medline Medical Convenience Kits Recalled Due to Potential Bacillus Contamination

    Medline Industries, LP is recalling specific Medline NEURO PACK convenience kits because they may contain low levels of Bacillus species contamination.

    Product
    Medline medical convenience kits labeled as: NEURO PACK, Medline Kit SKU DYNJ59397P
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Drugs)·D-0735-2026·2026-07-29

    Dabigatran Etexilate Capsules Recalled Over Impurity Test Failure

    Ascend Laboratories is recalling 1,753 cartons of dabigatran etexilate capsules (lot 25141707) due to out-of-specification results in impurity testing during 12-month stability studies.

    Product
    DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0724-2026·2026-07-29

    Cyproheptadine Hydrochloride Syrup Recall Due to Precipitate

    Rising Pharma is recalling cyproheptadine hydrochloride syrup due to the presence of precipitate, including crystallization and floating particles in the bottle.

    Product
    CYPROHEPTADINE HYDROCHLORIDE — CYPROHEPTADINE HYDROCHLORIDE (CYPROHEPTADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2761-2026·2026-07-29

    Olympus 4K UHD LCD Monitors Recalled Due to Potential Connector Faults

    Olympus Corporation of the Americas is recalling 10 Olympus 4K UHD LCD Monitors (Model OEV321UH) because the HDMI and DisplayPort connectors may become faulty.

    Product
    Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical information in color.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2773-2026·2026-07-29

    Pipeline Flex Embolization Devices Recalled Due to Incorrect Labeling of Implant Length

    Micro Therapeutics, Inc. is recalling Pipeline Flex Embolization Devices because the labeled implant length does not match the actual device length.

    Product
    Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm flow diverter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2752-2026·2026-07-29

    FARASTAR PFA Generator and Cardiac Ablation Catheter Recalled Due to Labeling Discrepancy

    Boston Scientific Corporation is recalling 11 units of FARASTAR PFA Generators and Percutaneous Cardiac Ablation Catheters because the Instructions For Use did not include FARAPOINT PFA catheter information.

    Product
    FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2763-2026·2026-07-29

    Halyard EYE PACK Convenience Kits Recalled Due to Incorrect Betadine Concentration

    AVID Medical, Inc. is recalling certain Halyard EYE PACK convenience kits because the Betadine solution contained within them has an incorrect concentration.

    Product
    Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2758-2026·2026-07-29

    Phantom Hindfoot Guide Rods Recalled Due to Sterile Barrier Breaches

    Paragon 28 is recalling specific Phantom Hindfoot TTC/TC Ball Tipped Guide Rods because of complaints regarding breaches in the sterile pouch packaging.

    Product
    P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0729-2026·2026-07-29

    FDA Recalls Xylocaine Injections Due to Hair Contamination

    FDA is recalling Xylocaine (lidocaine HCl) injections due to the presence of particulate matter, specifically hair found in the product.

    Product
    XYLOCAINE — XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2675-2026·2026-07-29

    BOSS Xe Family Aiming Devices Recalled for Software Safety Enhancement

    Wilcox Industries Corp. is recalling BOSS Xe family aiming devices to implement a software enhancement designed to increase safety.

    Product
    The intended use is to be paired with a weapon for aiming purposes.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2750-2026·2026-07-29

    FARASTAR Ablation Generator EU Medical Device Recall for Labeling Discrepancy

    Boston Scientific is recalling 18 FARASTAR Ablation Generator EU devices due to missing FARAPOINT PFA catheter information in the Instructions For Use.

    Product
    FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0712-2026·2026-07-29

    FDA Recalls Amlodipine and Olmesartan Tablets Over Failed Dissolution Test

    Ascend Laboratories is recalling 6,192 bottles of Amlodipine and Olmesartan Medoxomil tablets nationwide due to failed dissolution specifications and Olmesartan content below specifications.

    Product
    AMLODIPINE AND OLMESARTAN MEDOXOMIL — AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2769-2026·2026-07-29

    Silent Nite Sleep Appliance Recalled Due to Lack of FDA Clearance

    Prismatik Dentalcraft, Inc. is recalling Silent Nite Sleep Appliances because the device does not have FDA clearance.

    Product
    Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description: Silent Nite Sleep Appliance is a mandibular advancement device (MAD) intended to treat snoring and mild to moderate obstructive sleep apnea (OSA).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0725-2026·2026-07-29

    Glycopyrrolate Injection Recall Due to Hair Contamination

    Fresenius Kabi is recalling Glycopyrrolate Injection due to the presence of particulate matter, specifically hair found in the product.

    Product
    GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2775-2026·2026-07-29

    SnapshotGLO Wound Imaging Device Recalled Due to Battery Charging Software Issue

    Kent Imaging, Inc. is recalling SnapshotGLO Wound Imaging Devices (Models KB100 and KB100AA) because software issues may prevent the device from recharging.

    Product
    SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0736-2026·2026-07-29

    Drug Recall: Dabigatran Etexilate Capsules 150 mg by Ascend Laboratories

    Ascend Laboratories is recalling 2,717 cartons of Dabigatran Etexilate Capsules, 150 mg, because stability testing found impurities above specification.

    Product
    DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2774-2026·2026-07-29

    Embolization devices recalled due to incorrect labeling of implant dimensions

    Micro Therapeutics, Inc. is recalling Pipeline Flex Embolization Devices because the labels may incorrectly state the implant length.

    Product
    Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0758-2026·2026-07-29

    Supernus Recalls Trokendi XR Capsules for Failed Dissolution Specifications

    Supernus Pharmaceuticals is recalling Trokendi XR (topiramate) capsules because they failed dissolution specifications. The recall covers 15,853 bottles distributed nationwide.

    Product
    TROKENDI XR — TROKENDI XR (TOPIRAMATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·H-1184-2026·2026-07-29

    Island Pacific Imitation Crab Flakes Recalled Due to Undeclared Sodium Tripolyphosphate

    Shandong Ling Xian Food Co., LTD is recalling Island Pacific Imitation Crab Flakes because they contain undeclared sodium tripolyphosphate.

    Product
    Island Pacific IMITATION CRAB FLAKES NET WT: 1.0 LB (454g) UPC: 0000000175012 PRECOOKED SERVE HOT OR COLD INGREDIENTS: POLLOCK AND/OR THREADFIN BREAM, WATER, POTATO STARCH, TAPIOCA STARCH, CORN STARCH, SALT, SUGAR, MIRIN (RICE WINE), SOYBEAN OIL, SOYBEAN PROTEIN, CRAB EXTRACT…
    Category
    Food
    Distribution
    1 state
  • LowFDA (Devices)·Z-2751-2026·2026-07-29

    FARASTAR Cardiac Ablation Generator Recall for Missing Catheter Information

    Boston Scientific recalls cardiac ablation generators due to incomplete Instructions For Use that omit information about a compatible catheter.

    Product
    FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Food)·H-1182-2026·2026-07-29

    Island Pacific Imitation Crab Sticks Recalled Due to Undeclared Sodium Tripolyphosphate

    Island Pacific imitation crab sticks are being recalled because they contain undeclared sodium tripolyphosphate.

    Product
    Island Pacific IMITATION CRAB STICKS NET WT: 1.0 LB (454g) UPC: 0000000175029 PRECOOKED SERVE HOT OR COLD INGREDIENTS: POLLOCK AND/OR THREADFIN BREAM, WATER, POTATO STARCH, TAPIOCA STARCH, CORN STARCH, SALT, SUGAR, MIRIN (RICE WINE), SOYBEAN OIL, SOYBEAN PROTEIN, CRAB EXTRACT…
    Category
    Food
    Distribution
    1 state