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.

4251–4275 of 88106

  • HighFDA (Devices)·Z-1084-2026·2026-01-21

    Lucky Ice mouthwash recalled over insanitary conditions at a distribution center

    Gold Star Distribution is recalling Lucky Ice Cool Mouthwash over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.

    Product
    Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0277-2026·2026-01-21

    Tylenol products recalled over insanitary conditions at a distribution center

    Gold Star Distribution is recalling Tylenol over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.

    Product
    TYLENOL a) 500 MG., 2'S DISPLAY, 50CT; b) COLD & FLU, 25CT/2S; c) COLD & FLU SEVERE, 2PK, 50CT; d) PM, 50CT; e) SINUS SEVERE, 2PK, 50CT
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1024-2026·2026-01-21

    Pepto Bismol recalled over insanitary conditions at a distribution center

    Gold Star Distribution is recalling Pepto Bismol over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.

    Product
    MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0282-2026·2026-01-21

    Carmex lip balm recalled over insanitary conditions at a distribution center

    Gold Star Distribution is recalling Carmex over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.

    Product
    Carmex a) jar, 12 count, UPC: 083078123154, 083078113155; b) Tube, PEG, 12 count, UPC: 083078123147, 083078113148
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0395-2026·2026-01-21

    Pound cakes recalled over undeclared soy missing from the label

    Ukrop's Homestyle Foods is recalling 61 pound cakes because the label did not include soy, which was used in the product.

    Product
    Ukrop's 6" Pound Cake with Buttercream Icing/Confetti NET WT 30 OZ (1.88lb/851g) CONTAINS: Egg, Milk, Wheat Made in a production area that also uses soy and tree nuts. UPC 7 22515 91849 5 Ukrop's Homestyle Foods, LLC Richmond, VA 23
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·H-0390-2026·2026-01-21

    Vaporizing chest rub recalled over insanitary conditions at a distribution center

    Gold Star Distribution is recalling Personal Care Vaporizing Chest Rub over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.

    Product
    DPA161 Shrimp Paste (Klong Kone) 'L' , 32 oz, 12 count , PLastic Jar, 12 packages / cases
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0281-2026·2026-01-21

    Ice gel recalled over insanitary conditions at a distribution center

    Gold Star Distribution is recalling Personal Care Ice Gel over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.

    Product
    Personal Care, Ice Gel, 8oz, 12 count, UPC 048155903463
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0286-2026·2026-01-21

    Deodorant products recalled over insanitary conditions at a distribution center

    Gold Star Distribution is recalling Deodorant products over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.

    Product
    Deodorant: a) Axe, Body Spray, Wild Spice, 6CT, 150ML, UPC: 600108736469; b) LUCKY MENS STICK DEODORANT, SPRING FRESH, 24CT, 2.5 OZ, UPC: 808829111668; c) LUCKY MENS STICK DEODORANT, FRESH COMFORT, 24CT, 1.6 OZ, UPC: 808829089103; d) LADY DEODORANT, CHERRY BLOSSOSM, 24CT…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1045-2026·2026-01-21

    SMV DSI nuclear medicine systems recalled over a potential detector fall

    GE HealthCare is recalling 3 units of the SMV DSI nuclear medicine system, because systems moved without adequate detector support may suffer a detector fall.

    Product
    SMV DSI, System, Tomography, Computed, Emission
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0284-2026·2026-01-21

    Heparin antibody test kits recalled over a defect producing negative results

    Diagnostica Stago is recalling 438 Asserachrom HPIA kits from one lot because a potential defect can affect every well in an impacted strip and produce negative results.

    Product
    LUCKY ICE, Cool Mouthwash, Alcohol Free, 16.9oz, 12CT, UPC: 808829108989
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0285-2026·2026-01-21

    Petroleum jelly recalled over insanitary conditions at a distribution center

    Gold Star Distribution is recalling Petroleum jelly over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.

    Product
    Petroleum jelly: a) Vaseline Petroleum Jelly, 1.75, 12CT, UPC: 6001085120946; b) Vaseline Men Cooling Petroleum Jelly, 100ML, 12CT, UPC: 60022141; c) Vaseline Vitamin E, Petroleum Jelly, 100ML, 12CT, UPC: 6001085121028; MEN FRESH PETROLEUM JELLY, 100ML, 12CT, UPC: 60022127; d)…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0385-2026·2026-01-21

    Rice and pigeon peas recalled over undeclared soy in 2,078 units

    ASK Foods is recalling 2,078 units of Publix Rice & Pigeon Peas over an undeclared soy allergen.

    Product
    Publix Rice & Pigeon Peas, Net Wt 32 oz (2lb), Plastic tray with clear lid, black film, and a pre-printed label. 6 (2lb) containers per case .
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0279-2026·2026-01-21

    TUMS antacid tablets recalled over insanitary conditions at a distribution center

    Gold Star Distribution is recalling TUMS antacid tablets over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.

    Product
    TUMS a) Assorted, 12 Ct.; b) Extra Strength (EX) Assorted Berries, 12-count #1194A *05/27; c)Extra Strength (EX) Assorted Fruit, 12-count, #1194C *03/27
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1079-2026·2026-01-21

    Azurion interventional systems recalled over nine identified software issues

    Philips Medical Systems Nederland is recalling 990 Azurion R3.0 systems over nine identified software issues, including loss of X-ray after a pedal tap and continuous restart.

    Product
    Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1101-2026·2026-01-21

    Spinal tray syringes recalled over a crack on the syringe collar

    ICU Medical is recalling 64,290 Portex Spinal Trays because syringes may have a crack on the collar, which may lead to delayed or repeated blood draws and blood leakage.

    Product
    Portex Spinal Tray, Item No. A3729-24 A3595
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0401-2026·2026-01-21

    SMV BodyTrack nuclear medicine systems recalled over a potential detector fall

    GE HealthCare is recalling 12 units of the SMV BodyTrack nuclear medicine system, because systems moved without adequate detector support may suffer a detector fall.

    Product
    Jumbo RAW SHRIMP, All Natural, Chemical Free, No artificial ingredients, NET WT. 32 OZ (2 LB) 907g UPC: 1 93968 00697 6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0396-2026·2026-01-21

    Pink rose pound cakes recalled because soy was not on the label

    Ukrop's Homestyle Foods is recalling 61 pound cakes with buttercream icing and pink roses because the label did not include soy, which was used in the product.

    Product
    Ukrop's 6" Pound Cake with Buttercream Icing/Pink Roses NET WT 44 OZ (2.75lb/1.25kg) CONTAINS: Egg, Milk, Wheat Made in a production area that also uses soy and tree nuts. UPC 7 22515 91452 7 Ukrop's Homestyle Foods, LLC Richmond, VA 23230
    Category
    Food
    Distribution
    2 states