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.

4226–4250 of 88106

  • HighFDA (Food)·H-0397-2026·2026-01-21

    Pound cakes with buttercream icing recalled over undeclared soy

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

    Product
    Ukrop's 6" Pound Cake with Buttercream Icing/Red Roses NET WT 30 OZ (2.06lb/936g) UPC 7 22515 91452 7 and Ukrop's 8" Pound Cake with Buttercream Icing/Red Roses NET WT 44 OZ (2.75lb/1.25kg) UPC 7 22515 91456 5 CONTAINS: Egg, Milk, Wheat Made in a production area that also uses…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0278-2026·2026-01-21

    Halls cough drops recalled over insanitary conditions at a distribution center

    Gold Star Distribution is recalling Halls Cough Drops across multiple flavours over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.

    Product
    Halls Cough Drops a) BAGS, MENTHOL, 12CT; b) BAGS, HONEY LEM, 12CT; c) BAGS, DEFENSE CITRUS, 12CT; d) BAGS, CHERRY, 12CT; e) M. CHERRY, 20 STK; f) BRAZIL, Cherry, 21CT/27.5G; f) LEMON. HONEY, 20CT #1180E; g) LIME FRESH, 20CT, #1182; h) MENTHOL BLUE, 20CT, #1180A; i) BRAZIL…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1093-2026·2026-01-21

    Cell wash solution recalled over fungal contamination of an affected lot

    Hologic is recalling 3,728 units of ThinPrep CytoLyt Solution over fungal contamination of the affected lot with Parengyodontium album.

    Product
    ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0263-2026·2026-01-21

    Alka Seltzer recalled over insanitary conditions at a distribution center

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

    Product
    Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 815556020033, 016500514473, b) Plus Cold & Flu, 2 tablets per packet in 36 count box, UPC: 016500594932
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0258-2026·2026-01-21

    Testosterone pellets recalled over a lack of assurance of sterility

    Advanced Pharmaceutical Technology is recalling 22,843 TESTO-100 testosterone pellets over a lack of assurance of sterility and potential microbial contamination.

    Product
    TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-1046-2026·2026-01-21

    Advil products recalled over insanitary conditions at a distribution center

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

    Product
    SMV BodyTrack, System, Tomography, Computed, Emission
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0272-2026·2026-01-21

    Liquid NyQuil recalled over insanitary conditions at a distribution center

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

    Product
    LIQUID NYQUIL a) regular, 12/8oz; b) cherry, 12/8oz
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1042-2026·2026-01-21

    Angioplasty balloon catheters recalled over inflation and deflation difficulty

    Boston Scientific is recalling 21 Coyote over-the-wire PTA balloon dilatation catheters over the potential for inflation and deflation difficulty during use in the peripheral vasculature.

    Product
    Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210; Catheter, Angioplasty, Peripheral, Transluminal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0283-2026·2026-01-21

    Shrimp paste recalled after the product tested high for lead

    Gusto Group is recalling 7 cases of Klong Kone shrimp paste after the product tested high for lead.

    Product
    Personal Care, Vaporizing Chest Rub, 4 oz, 12 count, UPC 048155903319
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1098-2026·2026-01-21

    Venous stents recalled over a nitinol anomaly that reduces deployed diameter

    Medtronic is recalling 442 Abre Venous Self-Expanding Stent Systems because a nitinol anomaly causes a reduced stent diameter and radial force when deployed, which may result in migration.

    Product
    Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1096-2026·2026-01-21

    Surgical access port kits recalled over trays that may crack

    Intuitive Surgical is recalling 41,526 da Vinci SP Access Port Kits because the Access Port System tray may develop cracks, potentially resulting in a sterility breach.

    Product
    da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0389-2026·2026-01-21

    Medium shrimp paste recalled after the product tested high for lead

    Gusto Group is recalling 7 cases of Klong Kone shrimp paste in the 16 oz medium size after the product tested high for lead.

    Product
    Shrimp Paste (Klong Kone) 'M' , 16 oz, 24 count , PLastic Jar, 24 packages/ case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0287-2026·2026-01-21

    Ground cinnamon recalled over elevated levels of lead

    Eureka Inc is recalling 32 cases of ground cinnamon in 100g clear plastic containers over elevated levels of lead.

    Product
    Toothpaste: a) COLGATE, TOOTHPASTE, WHITENING, 2.5oz, 24ct; UPC: 035000511065; b) COLGATE, TOOTHPASTE, Regular, 2.5oz, 24ct, UPC: 035000511058; c) COLGATE, TOOTHPASTE, TRIPLE, 2.5oz, 24ct, UPC: 035000512109; d) COLGATE, TOOTHPASTE, MINT ZING, 24CT, 2.5oz, UPC: 035000744609…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1082-2026·2026-01-21

    Swan rubbing alcohol recalled over insanitary conditions at a distribution center

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

    Product
    Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system…
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-1094-2026·2026-01-21

    Infusion pumps recalled over speakers that may not produce audible alarms

    ICU Medical is recalling 423 Plum Duo Infusion Systems after one lot of defective primary speakers may fail to produce sound, so the pump may not produce audible alarms or alerts.

    Product
    Plum Duo Infusion System, List Number 40002-04-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0388-2026·2026-01-21

    Colgate toothpaste recalled over insanitary conditions at a distribution center

    Gold Star Distribution is recalling Colgate toothpaste in 2.5oz 24-count packs over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.

    Product
    Cinnamon, Clear Plastic Container, 100G, UPC 6251136 034139
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-1078-2026·2026-01-21

    Oncology information system recalled over a potential for overtreatment

    Elekta is recalling a MOSAIQ Oncology Information System with Particle Therapy License because a specific sequence can result in a partial treatment being delivered twice.

    Product
    MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0262-2026·2026-01-21

    Aleve recalled over insanitary conditions at a distribution center

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

    Product
    Aleve 1's, 60 CT
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1092-2026·2026-01-21

    Patient positioning systems recalled over stereotactic radiosurgery tolerance errors

    C-RAD Positioning is recalling 189 Catalyst and Catalyst+ systems because the system may indicate a patient as correctly positioned at the isocenter when it is outside tolerance.

    Product
    Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version: cSRS module in combination with cMotion module Product Description: GMDN: 40893 Patient positioning device, diagnostic imaging/radiotherapy, laser…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1058-2026·2026-01-21

    Children's NyQuil recalled over insanitary conditions at a distribution center

    Gold Star Distribution is recalling Children's NyQuil Cold & Flu over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.

    Product
    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medline kit SKU DYKS1339B; 2) ADMIN KIT, Medline kit SKU DYKS1339C; 3) QCASC WELCOME KIT, Medline kit SKU DYKS1359B; 4) ADMISSION KIT, Medline kit SKU…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1057-2026·2026-01-21

    Levothyroxine tablets recalled after a bottle held the wrong strength

    Alvogen is recalling a lot of Levothyroxine Sodium Tablets, 150mcg, after a pharmacy reported a single bottle containing 88 mcg tablets instead of 150 mcg tablets.

    Product
    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) PRE OP KIT, Medline kit SKU DYKS1093B; 2) PRE OP KIT, Medline kit SKU DYKS1124C; 3) PRE OP KIT, Medline kit SKU DYKS1128C; 4) PREOP KIT, Medline kit SKU DYKS1130B; 5)…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0398-2026·2026-01-21

    Non-dairy frozen dessert recalled over foreign material in millions of units

    WhiteWave is recalling 4,665,608 US units of So Delicious Dairy Free Salted Caramel Cluster Cashewmilk non-dairy frozen dessert over foreign material.

    Product
    So Delicious Dairy Free Salted Caramel Cluster Cashewmilk, Non-Dairy Frozen Dessert, One Pint (473 mL). UPC 744473 476138. Manufactured By/For So Delicious Dairy Free Eugene, OR 97402 So Delicious Dairy Free Salted Caramel Cluster Cashewmilk, Non-Dairy Frozen Dessert. Net wt.…
    Category
    Food
    Distribution
    Distributed nationwide