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.

14926–14950 of 27263

  • HighFDA (Drugs)·D-1159-2023·2023-09-27

    TRP Natural Eyes Floaters Relief Recalled for Lack of Sterility Assurance

    TRP Natural Eyes Floaters Relief sterile eye drops are being recalled because the manufacturer cannot assure the product meets sterility standards. It was distributed to two direct accounts in Rhode Island and Colorado.

    Product
    TRP Natural Eyes, Floaters Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-098-15.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-1154-2023·2023-09-27

    TRP Natural Eyes sterile eye drops recalled for lack of sterility assurance

    TRP Natural Eyes Blur Relief eye drops are being recalled due to lack of assurance of sterility. The product was distributed to accounts in Rhode Island and Colorado.

    Product
    TRP Natural Eyes, Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-002-11.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-1151-2023·2023-09-27

    FDA Recalls TRP Natural Eyes Eye Drops Due to Sterility Assurance Issue

    The FDA is recalling TRP Natural Eyes Aging Eye Relief eye drops due to lack of assurance of sterility. The affected lot DB001 (expiration 06/24) was distributed to accounts in Rhode Island and Colorado.

    Product
    TRP Natural Eyes, Aging Eye Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-027-15.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Food)·F-1536-2023·2023-09-27

    F-Bombs Cookies & Cream Truffles recalled for undeclared yellow food dyes

    Fox Confections LLC is recalling F-Bombs Cookies & Cream Truffles distributed in Illinois and Ohio due to undeclared FD&C Yellow #5 and Yellow #6 food colorants that may cause allergic reactions in sensitive individuals.

    Product
    F-Bombs Cookies & Cream Truffles: 12 ounce plastic packaging, plastic packaging is packed into 4x4x2 cardboard boxes. UPC 850036018025
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-1165-2023·2023-09-27

    TRP Natural Eyes Stye Relief sterile eye ointment recalled for lack of sterility assurance

    FDA is recalling TRP Natural Eyes Stye Relief sterile eye ointment due to lack of assurance of sterility. The product was distributed to two accounts in Rhode Island and Colorado.

    Product
    TRP Natural Eyes, Stye Relief, Sterile Eye Ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-014-13.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Food)·F-1519-2023·2023-09-27

    Trail Mix Products Recalled for Undeclared Soy and Wheat Allergens

    Mount Franklin Foods LLC is recalling Circle K Get Up Trail Mix and 7 Select Go! Smart Rise & Shine products nationwide because they may contain undeclared soy and/or wheat allergens due to mislabeling.

    Product
    1. Circle K Get Up Trail Mix, Net Wt 2 oz, UPC 194283102893 2. Circle K Get Up Trail Mix, Net Wt 6 oz, UPC 194283104262 3. 7 Select Go! Smart Rise & Shine, Net Wt 2.5 oz, UPC 00052548681500
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2620-2023·2023-09-27

    Copan Transfer Pipette Recalled Due to Plastic Defects

    Copan Diagnostics is recalling 2,592 units of 300µL transfer pipettes due to plastic defects that may affect aspiration capability. Affected units were distributed in California.

    Product
    COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2599-2023·2023-09-27

    Stryker ACM Cement Mixer Nozzle Risk of Disassembly During Surgery

    Stryker is recalling certain ACM (Advanced Cement Mixing) systems due to risk that the Break-Away Femoral Nozzle may disassemble or break during use, potentially causing loss of function and components entering the surgical site.

    Product
    Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid Blades-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-564-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2610-2023·2023-09-27

    TyTek Tension Pneumothorax Access Kit Recalled for Inadequate Placement Instructions

    Tytek Medical Inc is recalling the TyTek Tension Pneumothorax Access Kit (Model TM-303) because the instructions do not adequately identify the risks associated with needle decompression or clearly show proper placement site location.

    Product
    TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-303
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-1534-2023·2023-09-27

    Chocolate Truffles Recalled for Undeclared Yellow Food Dyes

    Fox Confections is recalling F-Bombs Original Truffles due to undeclared Yellow #5 and Yellow #6 food dyes not listed on the label. Consumers with sensitivities to these dyes may be affected.

    Product
    F-Bombs Original Truffles: 12 ounce plastic packaging, plastic packaging is packed into 4x4x2 cardboard boxes. UPC 850036018001
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2602-2023·2023-09-27

    Stryker ACM System nozzle may disassemble during bone cement mixing

    The break-away femoral nozzle in Stryker's ACM System may disassemble during use, potentially leaving fragments in the surgical site and causing device failure.

    Product
    Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Med. Press- Allows the user to mix bone cement with a constant high vacuum through the process. Catalog Number: 0306-705-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1542-2023·2023-09-27

    Sauce Product Recalled for Undeclared Soy Allergen in Texas

    Somebody's Mother's Island Sauce is recalled due to undeclared soy. Consumers with soy allergies may have an allergic reaction if exposed to this product.

    Product
    Somebody's Mother's Island Sauce, Net Wt 9.5 oz (270g), UPC 5803100115
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2607-2023·2023-09-27

    Orthopedic implant components recalled due to sterilization failure

    Encore Medical is recalling 15 orthopedic implants (DJO Surgical Altivate Reverse) due to sterilization failure. If implanted, unsterilized components may cause infection requiring treatment, monitoring, or revision surgery.

    Product
    DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2603-2023·2023-09-27

    Orthopedic knee implant component lacks final sterilization before shipment

    Encore Medical recalls 20 DJO Surgical Empowr Knee tibia baseplate components that were not sterilized before shipment. If implanted, these components may cause infection requiring treatment or revision surgery.

    Product
    DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Food)·F-1545-2023·2023-09-27

    Radish Turnip Cake Recalled for Undeclared Wheat Starch and Sulfites

    Southern Taiwan LLC is recalling Radish Turnip Cake distributed in Washington due to undeclared wheat starch and sulfites. The product poses a risk to consumers with wheat or sulfite allergies.

    Product
    Radish Turnip Cake (w/o shrimp): The product comes in a 900g ( 32 ounce), clear plastic package marked with UPC # 425404904110. Ingredients: White Radish, Mushrooms, Fried Dried shallot, White Rice Flour.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1518-2023·2023-09-27

    Circle K Sweet & Spicy Mix recalled for undeclared soy and wheat allergens

    Mount Franklin Foods is recalling Circle K Sweet & Spicy Mix nationwide due to potential undeclared soy and wheat allergens caused by mislabeling. Consumers with soy or wheat allergies should not consume the product.

    Product
    Circle K Sweet & Spicy Mix, Net Wt 7 oz; UPC 194283104613
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1530-2023·2023-09-27

    HEB Easy Melt Pasteurized Cheese Spread Recalled for Conflicting Refrigeration Labels

    Great Lakes Cheese is recalling HEB Easy Melt Original Pasteurized Process Cheese Spread because refrigeration instructions vary across product labels. No illnesses have been reported.

    Product
    Pasteurized Process Cheese Spread packaged under the following brands and sizes: 1. HEB Easy Melt Original, Net Wt 16 oz (1 lb) 453g. UPC 0 41220-73808 3. Refrigerate after Opening. Made with Pride and Care for H-E-B, San Antonio, Texas 78204 2. HEB Easy Melt Original, Net
    Category
    Food
    Distribution
    32 states
  • ModerateFDA (Devices)·Z-2592-2023·2023-09-27

    Sentec Membrane Changer components recalled for manufacturing defect

    SenTec AG recalls Membrane Changer components for the Sentec Digital Monitoring System due to a potential manufacturing defect that could affect measurement accuracy.

    Product
    Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1173-2023·2023-09-27

    Kroger Mint Burst Antiseptic Mouth Rinse recalled for undeclared excipients

    Vi-Jon, LLC is recalling 245,904 bottles of Kroger Mint Burst Antiseptic Mouth Rinse due to incorrect or undeclared excipients. The product was distributed through a single distributor with seven distribution centers.

    Product
    Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalyptol 0.092%, menthol 0.042%, Methyl salicylate 0.06%, thymol 0.064%), packaged in 16.9 FL OZ (500 mL) bottle, DISTRIBUTED BY THEKROGER CO. CINCINNATI, OHIO 45202, UPC 011110380807
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-1524-2023·2023-09-27

    Giant Eagle Cheese Spread Recalled Due to Inconsistent Refrigeration Labels

    Giant Eagle Easy Melt cheese spread products have inconsistent refrigeration instructions on their labels. The varying label requirements may cause improper storage, creating potential food safety concerns.

    Product
    giant eagle Easy Melt, Pasteurized Prepared Cheese Spread. Net Wt 32 oz (2lb)907g. UPC 0 30034-06289 7. Refrigerate after Opening. Distributed by Giant Eagle, Inc., Pittsburgh, PA 15328-2809.
    Category
    Food
    Distribution
    32 states
  • ModerateFDA (Food)·F-1525-2023·2023-09-27

    Pasteurized Process Cheese Spread Recalled for Conflicting Refrigeration Labels

    Great Lakes Cheese and related brands recalled 7.2 million pounds of pasteurized cheese spread due to conflicting refrigeration instructions on labels that may prevent proper storage.

    Product
    Pasteurized Process Cheese Spread packaged under the following brands and sizes: 1. Great Lakes Cheese Easy Cheesy, Net Wt 32 oz (2lb)907g. UPC 0 36514-19245 0. Refrigerate After Purchase. Distributed by Great Lakes Cheese Co., Inc. Hiram, OH 44234 2. HEB Easy Melt Queso B
    Category
    Food
    Distribution
    32 states
  • ModerateFDA (Devices)·Z-2611-2023·2023-09-27

    TyTek Tension Pneumothorax Access Kit Instructions Updated for Needle Decompression Safety

    Tytek Medical is updating instructions and visual guidance for its tension pneumothorax kit to clarify needle decompression risks and proper placement. The update affects 4,400 units distributed in the US and international locations.

    Product
    TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-310
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2613-2023·2023-09-27

    Prucka 3 Amplifier Power Supply May Fail and Cause Device Inoperability

    GE Medical Systems is recalling Prucka 3 Amplifiers and related field replaceable units used in CardioLab and ComboLab systems. A power supply diode may overheat and fail, causing the amplifier to stop working.

    Product
    Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2609-2023·2023-09-27

    Chemistry Quality Control Material Recalled for Transcription Error in Instructions

    Randox Laboratories recalled Liquid Assayed Chemistry Control Premium Plus Level 3 due to incorrect standard deviation values in the product instructions. The error could affect patient result reporting, but the correct operating values remain available.

    Product
    Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Food)·F-1527-2023·2023-09-27

    Great Value Cheese Recall Due to Inconsistent Refrigeration Label Requirements

    Great Value Melt'n Dip Easy Melt Cheese is being recalled due to inconsistent refrigeration labeling requirements that may result in improper storage. The product has a use-by date of 1/4/2024 or earlier.

    Product
    Great Value Melt'n Dip Easy Melt Cheese, Reduced Fat Pasteurized Prepared Cheese Product, Net Wt 32 oz (2 lbs) 907g. UPC 0 78742-01517 0. Refrigerate after Opening. Distributed By: Walmart Inc., Bentonville, AR 72716
    Category
    Food
    Distribution
    32 states