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.

7326–7350 of 26961

  • HighFDA (Devices)·Z-1105-2025·2025-02-12

    NeiMed NasoGel nasal spray recalled due to stability failure

    Neilmed Pharmaceuticals is recalling NasoGel for Dry Noses due to stability failure that may allow microbial growth. The product was distributed across 30 U.S. states and to five countries.

    Product
    NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL GSP30-SWE-INTL GSP30-ENG-INT GSP30-MAL-INTL GSP30-SPA-INT NasoGel Spray is a saline-based gel formula that can be sprayed to moisturize and lubricate dry and i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0460-2025·2025-02-12

    Monkey Spit BBQ Sauce recalled for undeclared milk allergen

    Monkey Spit Monkey Mop BBQ Sauce is recalled because it contains undeclared milk from butter, a common allergen. Consumers with milk allergies should not consume this product.

    Product
    Monkey Spit "Monkey Mop" BBQ Sauce, 12 fl oz (355ml) glass bottle, 12 bottles/case; Refrigerate after opening; Manufactured by Smith House MFG. 146-A S. Thompson Ave. Nipomo, CA 93444 (805)619-7959 Monkey Spit, LLC, UPC#8 54540 00206 8
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1090-2025·2025-02-12

    Philips Azurion 5 M20 Patient Tables Recalled for Finger Entrapment Hazard

    Philips Azurion 5 M20 x-ray system patient tables can trap fingers between the tabletop and guiding rails during repositioning. The hazard may cause finger injury to operators and service personnel.

    Product
    Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0465-2025·2025-02-12

    FDA Recalls Greenwise Organic Pecan Halves for Undeclared Walnuts

    The FDA has recalled Greenwise Organic Pecan Halves (8-ounce bags) due to undeclared walnuts, a major allergen. The affected product was distributed in eight southeastern states.

    Product
    Greenwise Organic Pecan Halves 8 ounce, plastic printed package marked with lot # 18228 and with a best by date of April.23.2025 stamped on front UPC: 041415212336
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1045-2025·2025-02-12

    GE Discovery XR656 HD X-ray system AEC control malfunctions during imaging

    GE Medical Systems is recalling the Discovery XR656 HD X-ray imaging system due to a malfunction in the Automatic Exposure Control (AEC) feature. The defect allows continued X-ray exposure beyond intended limits without requiring operator acknowledgment.

    Product
    Discovery XR656 HD. X-Ray imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1103-2025·2025-02-12

    Nitrous Oxide Cartridges Recalled Due to Premature Valve Opening

    Integra Miltex CryoSolutions N2O cartridges are recalled because the valve may open prematurely, causing partial or complete cartridge emptying before use. Affected units were distributed nationwide and to Canada.

    Product
    Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1104-2025·2025-02-12

    Integra Miltex Cryosolutions Cartridges Recalled for Premature Valve Opening

    The Integra Miltex Cryosolutions Cartridges (Model C-CA-23) are being recalled because the valve may open prematurely during assembly, causing the cartridge to empty before use. Approximately 3,352 units were distributed nationwide in the US and Canada.

    Product
    Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0214-2025·2025-02-12

    Timolol Maleate eye drops recalled for defective dropper cap

    FDC Limited is recalling Timolol Maleate ophthalmic solution because the dropper cap spike may become lodged in the bottle nozzle, preventing access to the medication. The recall affects one lot distributed to a single U.S. distributor in New Jersey.

    Product
    TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1112-2025·2025-02-12

    Beckman Coulter Access PCT Reagent Pack Recalled for Calibration Failures

    Beckman Coulter Inc. is recalling specific lots of Access PCT Reagent Pack due to high rates of calibration failures that delay test result reporting on immunoassay systems used in healthcare and laboratory settings.

    Product
    Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0222-2025·2025-02-12

    Guaifenesin and Codeine Cough Syrup Recalled for Superpotent Strength

    PAI Pharmaceutical Associates is recalling Guaifenesin and Codeine Phosphate Oral Solution because the product contains higher-than-labeled active ingredient concentrations. The affected product was distributed in Ohio.

    Product
    GUAIFENESIN AND CODEINE PHOSPHATE — GUAIFENESIN AND CODEINE PHOSPHATE (GUAIFENESIN AND CODEINE PHOSPHATE)
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0211-2025·2025-02-05

    Prograf Tacrolimus Capsules Recall: Empty Capsules in Bottles

    Astellas Pharma recalls Prograf (tacrolimus) 0.5 mg capsules distributed nationwide due to empty capsules in bottles. Affected lot 0E3353D expires March 31, 2026.

    Product
    PROGRAF — PROGRAF (TACROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0454-2025·2025-02-05

    Sushi Rolls Recalled Due to Possible Salmonella Contamination

    GBC Food Services (Yummi Sushi) has recalled multiple sushi roll products due to possible Salmonella contamination. The affected products were distributed in Texas and have best-by dates of 11/30/2024.

    Product
    Vegetarian Roll UPC: 85375900869 Qty: 1 Tray, Net Wt: 6.1oz (174g) 11/22 to 11/29/2024 Vegetarian Roll (Brown Rice) UPC: 85694200824 Qty: 1 Tray, Net Wt: 6.1oz (174g) 11/22 to 11/29/2024 Mixed Vegetable Roll (Brown Rice) UPC: 85694200880 Net Wt: 7.1oz (202g) 11/22 to 11/29/2024 V
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0428-2025·2025-02-05

    Lay's Classic Potato Chips recalled for undeclared milk allergen

    Frito Lay Inc. is recalling 6,344 bags of 13 oz. Lay's Classic Potato Chips distributed in Washington and Oregon due to an undeclared milk allergen that could cause allergic reactions.

    Product
    13 oz. Lay's Classic Potato Chips.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0210-2025·2025-02-05

    FDA Class I Recall: Astagraf XL Immunosuppressant Capsules May Be Empty

    Astellas Pharma is recalling Astagraf XL (tacrolimus) due to manufacturing defects; bottles shipped nationwide may contain empty capsules instead of medication.

    Product
    ASTAGRAF XL — ASTAGRAF XL (TACROLIMUS EXTENDED-RELEASE CAPSULES)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0435-2025·2025-02-05

    Food Recall: Large Vegetable Tray Due to Potential Salmonella

    GBC Food Services recalls a Large Vegetable Tray due to potential Salmonella contamination. Consumers who purchased this product between November 22-29, 2024, should not consume it.

    Product
    Large Vegetable Tray 850054894571 42 oz (1190g)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0437-2025·2025-02-05

    Cucumber slices with Tajin recalled for potential Salmonella contamination

    GBC Food Services is recalling 6,088 units of Cucumber Slices W/Tajin (10 oz, UPC 850053685699) due to potential Salmonella contamination. Products purchased November 22-29, 2024, distributed in Colorado are affected.

    Product
    Cucumber Slices W/Tajin 850053685699 10 oz (284g)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0444-2025·2025-02-05

    Family Cobb Salad Recalled for Potential Salmonella Contamination

    GBC Food Services, LLC (dba Yummi Sushi) is recalling Family Cobb Salad due to potential Salmonella contamination. The affected product was distributed in Colorado.

    Product
    Family Cobb Salad 850054894625 22 oz (623g)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0453-2025·2025-02-05

    Yummi Sushi Bao Buns and Gyoza Recalled for Possible Salmonella Contamination

    Yummi Sushi is recalling Karaage Chicken Bao Buns and Gyoza Combo products due to possible Salmonella contamination. The affected products were distributed in Texas with a best-by date of 11/30/2024.

    Product
    Karaage Chicken Bao Buns UPC: 85006499045 Net Wt: 8.8 oz (251g) 11/22 to 11/29/2024 Gyoza Combo UPC: 85001442018 Qty: 11 pcs, Net Wt: 13.3 OZ (377g) 11/22 to 11/29/2024
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0450-2025·2025-02-05

    Sushi Products Recalled for Possible Salmonella Contamination

    GBC Food Services dba Yummi Sushi is recalling multiple prepared sushi products distributed in Texas due to possible Salmonella contamination. Products with code dates 11/22–11/29/2024 should not be consumed.

    Product
    Spicy Tuna with Spicy Mayo Roll UPC: 85375900839 Qty: 1 Tray, Net Wt: 7.8oz (223g) 11/22 to 11/29/2024 Spicy Tuna with Spicy Mayo Roll UPC: 85006061926 Qty: 1 Tray, Net Wt: 7.8oz (223g) 11/22 to 11/29/2024. Tuna Tataki Poke Bowl UPC: 85004566863 Net Wt: 14.5oz (412g) 11/22 to 11/
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0449-2025·2025-02-05

    Sushi rolls recalled for possible Salmonella contamination in Texas

    GBC Food Services has recalled multiple sushi products due to possible Salmonella contamination. The affected products were distributed in Texas with best-by dates through 11/30/2024.

    Product
    California Roll (Crab Salad) UPC: 85375900857 Qty: 1 Tray, Net Wt: 7.6oz (216g) 11/22 to 11/29/2024. California Roll (Crab Stick) UPC: 85375900858 Qty: 1 Tray, Net Wt: 7.6oz (216g) 11/22 to 11/29/2024 Volcano Roll UPC: 85375900886 Qty: 1 Tray, Net Wt: 10.8oz (305g) 11/22 to 11/29
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0431-2025·2025-02-05

    Frozen peach mango sorbet recalled for undeclared egg allergen

    The Mochi Ice Cream Company is recalling My Mochi Sorbet Peach Mango Sorbet nationwide due to undeclared egg allergen. Consumers with egg allergies should not consume this product.

    Product
    My Mochi Sorbet Peach Mango Sorbet; Keep Frozen; 6 pieces per container; 6-1.25 OZ (35g) PIECES NET WT 7.5 OZ (210g)*** Nutritional Panel: 6 servings per container; JOYFULLY CHILL!; Made in a nut-free facility; Made by My/Mochi, 5563 Alcoa Ave., Los Angeles, CA 90058; www.mymochi
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0439-2025·2025-02-05

    Salad Recall: Southwest Salad from Yummi Sushi Due to Salmonella Risk

    GBC Food Services is recalling Southwest Salad products (6,088 units) distributed in Colorado due to potential Salmonella contamination. Products purchased between November 22-29, 2024 may be affected.

    Product
    Southwest Salad 850065403069 Net Wt: 4oz (113g)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0451-2025·2025-02-05

    Multiple Sushi Rolls Recalled for Possible Salmonella Contamination

    Yummi Sushi has recalled multiple shrimp-based sushi roll products distributed in Texas due to possible Salmonella contamination. Consumers should not consume these products and should return them to the point of purchase.

    Product
    Tempura Shrimp Roll UPC: 85375900884 Qty: 1 Tray, Net Wt: 10oz (284g) 11/22 to 11/29/2024 Spicy Cajun Shrimp Roll UPC: 85006499076 Net Wt: 10.8 oz (305g) 11/22 to 11/29/2024 Shrimp Combo UPC: 85001442019 Qty: 7 pcs, Net Wt: 12.2 OZ (347g) 11/22 to 11/29/2024 Shrimp Avocado Roll
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0991-2025·2025-02-05

    Medline Arterial Line Insertion Kits Recalled for Catheter Hub Defect

    Medline Industries is recalling 942 arterial line insertion kits due to excess material on the catheter hub of the catheter subassembly. The manufacturing defect prompted a FDA Class I recall of products distributed nationwide.

    Product
    Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B; 2) ARTERIAL LINE BUNDLE, Item Number ART255; 3) ARTERIAL LINE TRAY, Item Number ART350; 4) ARTERIAL LINE BUNDLE, Item Number ART355; 5) ARTERIAL LINE BUNDLE, Item Number ART355 ; 6)
    Category
    Medical Device
    Distribution
    Distributed nationwide