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.

12201–12225 of 27206

  • HighFDA (Drugs)·D-0384-2024·2024-03-20

    FDA Recalls HylaTears Lubricant Eye Drops for Sterility Assurance Issue

    Optikem International is recalling 46,621 bottles of hyalogic For Dry Eyes, HylaTears Lubricant Eye Drops due to lack of assurance of sterility. The product is distributed nationwide.

    Product
    hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Platte Valley Dr., Riverside, MO 64150
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1283-2024·2024-03-20

    Ivenix Infusion System Software Defect May Delay or Cause Incorrect Infusions

    Fresenius Kabi recalls Ivenix Infusion System software versions 5.2.1 and 5.2.2 due to two defects that may delay therapy or cause over-infusion. The software fix was deployed to affected units between May and August 2023.

    Product
    LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0369-2024·2024-03-20

    Febuxostat tablets recalled due to microbial contamination in manufacturing

    Sun Pharmaceutical is recalling 7,488 bottles of Febuxostat 80mg tablets nationwide due to microbial contamination found in manufacturing equipment. No illnesses have been reported.

    Product
    FEBUXOSTAT — FEBUXOSTAT (FEBUXOSTAT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1298-2024·2024-03-20

    Hip prosthesis labeling clarification needed to prevent surgical confusion

    Waldemar Link is clarifying labeling on 153 hip prosthesis units after complaints about ambiguous Size and Type information. The guidance aims to prevent potential misinterpretation during surgery.

    Product
    SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1063-2024·2024-03-20

    Banana Pepper Rings 16 FL OZ recalled for punctured jar lids

    Lidl US TRADING is recalling Banana Pepper Rings due to punctured lids on glass jars, which may compromise product integrity. Affected jars were distributed across multiple states in the Mid-Atlantic and Southeast regions.

    Product
    Banana Pepper Rings 16 FL OZ (1PT) 473ml UPC:4056489223863. Packaged in a glass jar with metal lid.
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1287-2024·2024-03-20

    Aneurysm clips recalled due to incorrect blue coloring

    Peter Lazic Gmbh is recalling 170 L-Aneurysm Clip TITANIUM Paddle-Clips distributed in Maine due to incorrect blue coloring instead of blank.

    Product
    L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0387-2024·2024-03-20

    FDA Recalls Broncochem Cold & Tea Nationwide for Stability Failures

    Global Corporation is recalling Broncochem Cold & Tea nationwide due to stability testing failures in the active ingredients. No illnesses or injuries have been reported.

    Product
    BRONCOCHEM — BRONCOCHEM (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0386-2024·2024-03-20

    Broncochem Cold & Flu Syrup Kids Recalled Due to Stability Testing Failures

    Global Corporation is recalling Broncochem Cold & Flu Syrup Kids (120 mL bottles) nationwide due to stability testing failures in active pharmaceutical ingredients.

    Product
    Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packaged in 120 mL bottles, Made in Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-098-44
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1282-2024·2024-03-20

    Infusion Pump Software Defect Causes Incorrect Alarm and Therapy Delay

    Fresenius Kabi is recalling software versions 5.0.1 and earlier of the Ivenix Infusion System due to a software defect that may cause an incorrect pump alarm, potentially delaying therapy. The defect was resolved in software version 5.2.1, released in September 2022.

    Product
    LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1064-2024·2024-03-20

    Electric City Sweets Chocolate Bars Recalled for Undeclared Milk

    Electric City Sweets 1.75oz Red Velvet Milk Chocolate Bars are being recalled because milk is not properly declared on the packaging. The recall affects 1,644 bars distributed in California, Florida, Pennsylvania, and North Carolina.

    Product
    Electric City Sweets 1.75oz Red Velvet Milk Chocolate Bar. Individually wrapped in paper/foil packaging.
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-1061-2024·2024-03-20

    Vitony Bakery Cheesecake Recalled for Undeclared Food Dyes

    Vitony Bakery cheesecake products are being recalled due to undeclared FD&C Yellow #5 and Yellow #6 dyes. The recall affects 6,916 units distributed to Puerto Rico and may pose risks to consumers with sensitivities to these colorants.

    Product
    Vitony Bakery, Bizcocho de Queso (cheesecake), PESO NETO 14oz (397g) (12 (14 oz) packages per case)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1294-2024·2024-03-20

    BVI Visitec Irrigation Handle lacks manufacturing and expiration dates

    Beaver Visitec International is recalling 3,000 BVI Visitec Irrigation Handles because the pack and pouch labels are missing manufacturing and expiration date information.

    Product
    BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number: 581012
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1288-2024·2024-03-20

    Aneurysm clips recalled due to incorrect paddle coloring

    Peter Lazic Gmbh is recalling 51 titanium aneurysm clip paddle clips because the clips are colored blue when they should be blank.

    Product
    L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Non-Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1035-2024·2024-03-13

    Frios Gourmet Pops Frozen Popsicles Recalled for Undeclared Egg Allergen

    Frios Gourmet Pops frozen popsicles are being recalled because they contain undeclared egg, an allergen. Consumers with egg allergies may face allergic reactions if they consume these products.

    Product
    Frios Gourmet Pops - Banana Pudding Popsicle 3oz frozen popsicle packaged individually in clear plastic sleeve. 48 popsicles per box. *Sold directly to end consumer via food truck
    Category
    Food
    Distribution
    17 states
  • CriticalFDA (Food)·F-1044-2024·2024-03-13

    Vegetarian Pia Cake Taro Durian Recalled for Undeclared Egg Allergen

    LQNN Inc. is recalling Vegetarian Pia Cake Taro Durian (14 oz bags) due to undeclared egg allergen. The recall affects approximately 222,320 bags distributed across 31 U.S. states and Canada.

    Product
    Vegetarian Pia Cake Taro Durian, 14 oz (400g)
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1050-2024·2024-03-13

    Vegetarian Pia Cake Recalled for Undeclared Egg Allergen

    LQNN Inc. is recalling 222,320 bags of Vegetarian Pia Cake Mung Bean Pineapple for containing undeclared egg. The product was distributed across 31 U.S. states and Canada.

    Product
    Vegetarian Pia Cake Mung Bean Pineapple, 14oz (400g)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1052-2024·2024-03-13

    Vegetarian Pia Cake Recalled for Undeclared Egg Allergen

    LQNN Inc. is recalling Vegetarian Pia Cake Red Bean Durian products due to undeclared egg allergen. The recall affects 222,320 bags distributed across 31 U.S. states and Canada.

    Product
    Vegetarian Pia Cake Red Bean Durian, 14oz (400g)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1030-2024·2024-03-13

    Chicken Enchilada Recall: Listeria Risk from Queso Fresno Cheese

    The Fierro Group Inc. (Rico Brands) is recalling Chicken Enchilada with Mole Rice & Beans due to potential Listeria monocytogenes contamination in the Queso Fresno cheese. Affected products were distributed to supermarkets in Utah.

    Product
    Chicken Enchilada with Mole Rice & Beans 14 oz. packaged in a in a Deep Meal tray with Plant Fiber - Film 800.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1048-2024·2024-03-13

    BANH PIA Hopia Cake Recalled for Undeclared Egg Allergen

    LQNN Inc. is recalling BANH PIA Hopia Cake Mungbean Durian due to undeclared egg allergen. The product was distributed to customers in 31 U.S. states and Canada.

    Product
    BANH PIA Hopia Cake Mungbean Durian, 9.7oz (275g)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1027-2024·2024-03-13

    Cheese Enchiladas Recalled for Potential Listeria Monocytogenes Contamination

    The Fierro Group Inc. is recalling Cheese Enchiladas with Red sauce due to potential contamination with Listeria monocytogenes. Products were distributed to supermarkets in Utah.

    Product
    Cheese Enchiladas with Red sauce 4/pkg 14.5oz packaged in a in a Deep Meal tray Plant Fiber - Film 800.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1051-2024·2024-03-13

    Vegetarian Pia Cake Pandan Durian Recalled for Undeclared Egg Allergen

    LQNN Inc. is recalling 222,320 bags of Vegetarian Pia Cake Pandan Durian due to undeclared egg allergen. Consumers with egg allergies should not consume this product.

    Product
    Vegetarian Pia Cake Pandan Durian, 14oz (400g)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1026-2024·2024-03-13

    Taylor Fresh Foods Roasted Street Corn Salad Recalled for Listeria Contamination Risk

    Taylor Fresh Foods recalls COLD CASE roasted street corn salad due to potential Listeria monocytogenes contamination. Affected: 60 cases across 28 states.

    Product
    COLD CASE, ROASTED STREET CORN SALAD 1/4.78# (KR) Separate Kit Items packed in sealed bag and placed in a plastic RPC container
    Category
    Food
    Distribution
    27 states
  • SevereFDA (Food)·F-1046-2024·2024-03-13

    Vegetarian Pia Cake Recalled for Undeclared Egg Allergen

    LQNN Inc. is recalling approximately 222,320 bags of Vegetarian Pia Cake Black Sesame Durian due to undeclared egg. Consumers with egg allergies should not consume this product.

    Product
    Vegetarian Pia Cake Black Sesame Durian, 14oz (400g)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1024-2024·2024-03-13

    Golden Owl Dried Mango Recall for Undeclared Sulfites

    Golden Owl Dried Mango (7 oz) is recalled due to undeclared sulfites. Consumers with sulfite sensitivity should not consume this product.

    Product
    Golden Owl Dried Mango 7 oz (200g) UPC 816710-024461. Packaged in clear non-flex plastic jars. 24 jars per case.
    Category
    Food
    Distribution
    17 states