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.

17426–17450 of 27263

  • ModerateFDA (Drugs)·D-0561-2023·2023-05-10

    Simvastatin 40 mg recalled nationwide for manufacturing quality deviations

    PD-Rx Pharmaceuticals voluntarily recalled Simvastatin 40 mg due to manufacturing quality issues. The recall affects 393 bottles distributed nationwide, with affected lot expiration dates ranging from May 2023 to April 2024.

    Product
    Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0726-30) b) 90 count-bottle (NDC 43063-0726-90)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0563-2023·2023-05-10

    Advil Ibuprofen Tablets Recalled for Storage Temperature Deviation

    Family Dollar Stores is recalling Advil Ibuprofen 200 mg tablets due to a storage temperature deviation during manufacturing and distribution. No illnesses have been reported.

    Product
    Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottles, and c) 3 (2 count) packets.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1557-2023·2023-05-10

    VITROS 5600 Integrated System MicroTip Pack Opener Assembly Defect

    Refurbished VITROS 5600 diagnostic systems may have a defective MicroTip Pack Opener Assembly that fails to properly remove or replace pack caps, potentially causing delayed test results. Ortho-Clinical Diagnostics is recalling 1,148 units distributed nationwide and internationally.

    Product
    VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0778-2023·2023-05-10

    Sofrito Marinating Sauce recalled for improper storage conditions

    20-100 Delicious Seasoning LLC recalls Sofrito Marinating Sauce because the product was not stored refrigerated as required. Consumers should not consume the product.

    Product
    Sofrito Marinating Sauce, 100% All Natural Ingredients (Caribbean Seasoning), Net Wt 16 oz. (460g), 8 oz. (230g) and 32(920g) oz. Glass Jar. Manufactured and Distributed by 20100 Seasoning LLC. Keep Refrigerated.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1482-2023·2023-05-10

    Hill-Rom Pro+ Hospital Mattress Covers Recalled for Delamination Risk

    Baxter is recalling Hill-Rom pro+ mattress covers that may delaminate, allowing fluid to seep into the mattress. No injuries have been reported.

    Product
    Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 21649301S, g) 21649401S, h) 21649402S, i) P006800A01, j) P006800A02, k) P3255A01, l) P3255A02, m) P3255A03, n) P3255ARENT01, o) P7923A01, p) P7923A02, q) P7923A0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1558-2023·2023-05-10

    DeVilbiss Healthcare 1025 Series Oxygen Concentrator Instruction Manual Update

    DeVilbiss Healthcare is updating the instruction manual for its 1025 Series Oxygen Concentrator to comply with IEC-60101-1 standard labeling requirements. This recall affects 143,397 units distributed nationwide and worldwide.

    Product
    DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1545-2023·2023-05-10

    LINK SLED Knee Implant Surgical Technique Update Required

    The LINK SLED Knee System requires updated surgical technique training due to risks of aseptic loosening and implant wear when improperly positioned or cemented. The manufacturer is issuing reinforced surgical guidelines and training to prevent unsatisfactory outcomes.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2230/04
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1537-2023·2023-05-10

    LINK SLED Knee System Tibial Implant Aseptic Loosening Risk

    The LINK SLED Knee System tibial implant may experience early aseptic loosening if not positioned or cemented properly during surgery. Linkbio recommends updated surgical technique training for optimal implant placement.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2030/14
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-0813-2023·2023-05-10

    Signature Select Oat & Nuts Bread Recalled for Potential Tree Nut Cross-Contamination

    Albertsons Companies LLC is recalling Signature Select Oat & Nuts Bread (20 oz) due to potential undeclared tree nut allergens from cross-contamination. Consumers with tree nut allergies should not consume affected products.

    Product
    Signature Select Oat & Nuts Bread NET WT 20 OZ (1 LB 8 OZ) 680 g Ingredients: Unbleached enriched wheat flour (wheat flour, malted barley flour, reduced iron, niacin, thiamine, mononitrate, riboflavin, folic acid), water, whole grain, oats, liquid sugar, yeast, hazelnuts, molasse
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-0814-2023·2023-05-10

    Nuts & Grain Bread Recalled for Undeclared Tree Nut Cross Contamination

    Signature Select Nuts & Grain Bread may contain undeclared tree nuts from potential cross contamination. The product is distributed in Western U.S. states and poses a risk to consumers with tree nut allergies.

    Product
    Signature Select Nuts & Grain Bread NET WT 20 OZ (1 LB 8 OZ) 680 g Ingredients: Unbleached enriched wheat flour (wheat flour, malted barley flour, reduced iron, niacin, thiamine, mononitrate, riboflavin, folic acid), water, walnuts, whole grain bulgur wheat, whole grain oats, sun
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0565-2023·2023-05-10

    Advil Dual Action Pain Reliever Recalled for Storage Temperature Deviation

    Family Dollar Stores is recalling Advil Dual Action pain reliever tablets (36-caplet bottles, SKU 0902867) nationwide because the product was stored outside labeled temperature requirements.

    Product
    Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0808-2023·2023-05-10

    Atkins Milk Chocolate Delight Protein Shakes Recalled for Spoilage Risk

    Simply Good Foods is recalling Atkins Milk Chocolate Delight Protein Shakes nationwide due to post-processing contamination that may cause spoilage. Affected products have lot numbers SA2208P3F6 (exp. 07/27/23) or SA2210P3F6 (exp. 07/29/23).

    Product
    Atkins Milk Chocolate Delight Protein Rich Shakes, NET WT. 44 oz (4 / 11oz), 4 Tetra Packs per carton, UPC 637480065016, Distributed exclusively by Simply Good Foods USA, Inc. Denver, CO 80202, 1-800-6-ATKINS
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1556-2023·2023-05-10

    VITROS 5600 system pack opener assembly may not function properly

    The MicroTip Pack Opener Assembly on VITROS 5600 systems may fail to remove or replace pack caps properly, making packs unusable and delaying clinical test results. Approximately 4,895 units were distributed.

    Product
    VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnosti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0559-2023·2023-05-10

    Drug Recall: Glimepiride 4 mg for Manufacturing Practice Deviations

    PD-Rx Pharmaceuticals is recalling 186 bottles of Glimepiride USP 4 mg due to manufacturing deviations. Patients using this medication should contact their healthcare provider to verify if their supply is affected.

    Product
    Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0587-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0802-2023·2023-05-03

    Savor Imports IQF Raspberries recalled for potential Hepatitis A contamination

    Savor Imports IQF Whole Raspberries (Lot 20220210) are recalled nationwide due to potential Hepatitis A contamination. Consumers should not eat the product and should return or discard it.

    Product
    Savor Imports IQF Whole Raspberries; Net Wt 2-5lb; MFG# 341798; UPC: 10684476003771
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0754-2023·2023-05-03

    Fresh Express Chopped Kit Recalled for Listeria monocytogenes

    Fresh Express Chopped Kit Chipotle Cheddar salad has been recalled because it tested positive for Listeria monocytogenes. The product was distributed to Florida, Georgia, North Carolina, South Carolina, and Virginia.

    Product
    Fresh Express Chopped Kit Chipotle Cheddar TOTAL NET WT. 11.3 oz (320G) SALAD TOPPINGS NET WT 9.1 oz (258Gg) DRESSING 2.3 fl. oz. (68 mL)/NET WT 2.2oz (62g) FRESH EXPRESS INCORPORATED P.O. BOX 80599, SALINAS, CA 93912 UPC 0 71279 30604 9
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0753-2023·2023-05-03

    Fresh EXPRESS Lettuce Salad Kit Recalled for Listeria

    Fresh EXPRESS Chopped Kit Caesar Romaine Lettuce has been recalled due to testing positive for Listeria monocytogenes. The affected product was distributed to Florida, Georgia, North Carolina, South Carolina, and Virginia.

    Product
    Fresh EXPRESS Chopped Kit Caesar Romaine Lettuce TOTAL NET WT. 9.4 OZ (266g) SALAD & TOPPINGS: NET WT. 6.9 OZ (196g) DRESSING 2.5 fl. oz. (74 mL)/NET WT 2.5 oz. (71g) fresh express incorporated P.O. BOX 80599, SALINAS, CA 93912 UPC 0 71279 30919 4
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0755-2023·2023-05-03

    Premium Makoto Honey Ginger Salad Kit Recalled for Listeria Contamination

    Fresh Express is recalling Premium Makoto Honey Ginger Salad Kits distributed in five states because the product tested positive for Listeria monocytogenes. Consumers should not consume this product.

    Product
    PREMIUM MAKOTO HONEY GINGER SALAD KIT TOTAL NET WT 8.75 OZ (248g) DRESSING 2.03 FL OZ (60 mL) SALAD & TOPPING 6.5 OZ (184g) DISTRIBUTED BY PUBLIX SUPER MARKETS, INC., LAKELAND, FL 33802 UPC 0 41415 18386 5
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0760-2023·2023-05-03

    Patagonia Foods Blackberries Recalled for Possible Hepatitis A

    Patagonia Foods is recalling frozen blackberries (Lot 20422) distributed in six U.S. states due to possible Hepatitis A contamination. Consumers should not consume the product.

    Product
    Patagonia Foods 3610100 Blackberry IQF Product of Mexico Net Wt. 30 LBS. (13.61 kg) Production/Lot Code 20422 Distributed By: Patagonia Foods, LLC. San Luis Obispo, CA 93401 patagoniafoods.com
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0749-2023·2023-05-03

    Lamb Weston Frozen Hash Brown Patties Recalled for Undeclared Wheat

    Lamb Weston Sales is recalling frozen hash brown patties due to undeclared wheat allergen. The recall affects approximately 1605 cases distributed to foodservice customers across multiple states and international locations.

    Product
    G5300 Lamb's Supreme Hash Brown Patties, Frozen, 24 patties packed in blank unlabeled tray, 12 trays packaged in one case. Net Wt. 33.75LB (15.30kg). UPC 1 00 44979 75300 7. The ingredients statement read: POTATOES, VEGETABLE OIL (CONTAINS OR OR MORE OF THE FOLLOWING: CANOLA, PA
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-1468-2023·2023-05-03

    Mani Trocar Kits Recalled for Packaging Defect Compromising Sterility

    Mani Trocar Kits (Models MTK23S and MTK25S) are being recalled due to a packaging defect that may compromise the sterile barrier. The recall affects 45 kits distributed to one consignee in Missouri.

    Product
    Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0543-2023·2023-05-03

    Peritoneal dialysis solution recalled due to sterility assurance concerns

    Baxter Healthcare Corporation is recalling 9,788 bags of Dianeal Low Calcium with Dextrose peritoneal dialysis solution due to potential leaks in the Luer component. The recall affects Lot Y405201 distributed nationwide in the United States.

    Product
    DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1467-2023·2023-05-03

    Stryker ORTHOLOC 3Di Fusion Plate Recalled for Incorrect Marked Descriptions

    Wright Medical Technology is recalling Stryker ORTHOLOC 3Di Fusion Plate MTP Right surgical implants due to incorrect dorsiflexion descriptions laser marked on 50 units distributed nationwide.

    Product
    stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1421-2023·2023-05-03

    Carefusion Vaginal Specula Recalled for Incorrect Labeling and Packaging

    Carefusion recalled 726 units of two vaginal specula models with labels and laser etchings switched during packaging. This mislabeling could result in use of an unintended product.

    Product
    (1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3.5cm); and (2) Carefusion V. Mueller Pederson Vaginal Specula, Catalog #GL31, Medium, 4 x 7/8" (10.2 x 2.2cm).
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1436-2023·2023-05-03

    Sterile surgical C-section kit light handle covers recalled for separation risk

    ROi CPS LLC recalls sterile surgical C-section kits due to light handle covers that may separate and fall during use. The recall affects 1,312 kits distributed in Florida and Missouri.

    Product
    Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
    Category
    Medical Device
    Distribution
    Distributed nationwide