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.

1651–1675 of 26545

  • HighFDA (Drugs)·D-0326-2026·2026-02-18

    Testosterone and Anastrozole Sterile Pellets Recalled for Potential Metal Contamination

    Asteria Health is recalling Testosterone 100mg/Anastrozole 4mg sterile pellets (NDC 79559-4104-01, Lot 254000104) nationwide due to potential metal particulate matter contamination.

    Product
    Testosterone 100mg, Anastrozole 4mg (4.5), 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0340-2026·2026-02-18

    Cetrorelix Acetate injection kit recall for defective delivery system

    Meitheal Pharmaceuticals is recalling 16,477 Cetrorelix Acetate injection kits due to missing or duplicated needles in the delivery system. Patients may be unable to properly administer the medication.

    Product
    CETRORELIX ACETATE — CETRORELIX ACETATE (CETRORELIX ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0337-2026·2026-02-18

    Vancomycin injectable solution recalled due to sterility assurance issues

    Fresenius Kabi is recalling vancomycin HCl injections distributed nationwide due to inability to assure product sterility. Two specific lots are affected.

    Product
    vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1315-2026·2026-02-18

    CT Scanner Rotor Fasteners May Become Loose During Operation

    Philips Brilliance iCT CT scanners are recalled because fasteners securing the rotor may not be properly tightened. If multiple fasteners are loose, rotor parts could become unsecured or displaced.

    Product
    Brilliance iCT; Product Code (REF): 728306;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0313-2026·2026-02-18

    Estradiol Sterile Pellets Recalled for Potential Metal Contamination

    F.H. Investments (Asteria Health) is recalling Estradiol 22 mg sterile pellets nationwide due to potential metal particulate matter contamination. Affected lot (253000126) expires 06/09/2026.

    Product
    ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3022-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0327-2026·2026-02-18

    Testosterone and Anastrozole Pellets Recalled for Potential Metal Contamination

    Asteria Health recalled Testosterone-Anastrozole injectable pellets due to potential metal particulate contamination. Affected lots 254000107 and 254000111 were distributed nationwide.

    Product
    Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4079-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0319-2026·2026-02-18

    Testosterone Pellets Recalled Due to Potential Metal Contamination

    F.H. INVESTMENTS, Inc. (dba Asteria Health) is recalling testosterone pellets nationwide due to potential metal particulate matter contamination. Approximately 60,868 pellets across five lot numbers are affected.

    Product
    Testosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1037-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0306-2026·2026-02-18

    Tablets of Doxazosin Mesylate 4 mg Recalled for Incorrect Imprinting

    Unichem Pharmaceuticals is recalling 60,000 Doxazosin Mesylate 4 mg tablets due to incorrect imprinting. Patients should check their medication bottles and contact their pharmacy if they have Lot #GDSH25006.

    Product
    DOXAZOSIN MESYLATE — DOXAZOSIN MESYLATE (DOXAZOSIN MESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1360-2026·2026-02-18

    Surepulse VS Cap Extra Large Recalled for Incorrect Sizing Guide

    The Surepulse VS Cap Extra Large component of newborn heart rate monitors has been recalled because the product labeling contains an incorrect sizing guide.

    Product
    Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1357-2026·2026-02-18

    Newborn Heart Rate Monitor Cap Has Incorrect Sizing Labeling

    Surepulse Medical recalls VS Cap Small components of newborn heart rate monitors due to incorrect sizing guidance in the labeling. The labeling error could affect proper device fit.

    Product
    Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1332-2026·2026-02-18

    Medline Suture Removal Trays Recalled Due to Potentially Open Packaging Seals

    Medline Industries is recalling 2,448 suture removal kits due to potentially open packaging seals on BD ChloraPrep Triple Swabsticks applicators, which could compromise sterility.

    Product
    Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU DYNDR1277A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1359-2026·2026-02-18

    Surepulse VS Cap Large Medical Device Recalled for Incorrect Sizing Guide

    Surepulse Medical is recalling the VS Cap Large, a component of the VS Newborn Heart Rate Monitor, due to incorrect sizing information in the labeling.

    Product
    Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0497-2026·2026-02-18

    Sugar substitute packets recalled due to undeclared aspartame ingredient

    Domino Foods is recalling Sodexo Stars Saccharin packets because the product contains undeclared aspartame. The recall affects 2,023 cases distributed across multiple states.

    Product
    Sodexo Stars Saccharin (Pink) Packets, Sugar Substitute, Net Wt 0.035 oz. (1g), Manufactured by Domino Foods, Inc., West Palm Beach, FL 33041
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Drugs)·D-0338-2026·2026-02-18

    Oxycodone Hydrochloride Tablets Recalled for Defective Blister Seals

    Amerisource Health Services is recalling Oxycodone Hydrochloride Tablets, 5 mg, nationwide due to defective blister card seals. Weak or non-existent seals may allow tablets to fall out of their cavities.

    Product
    OXYCODONE HYDROCHLORIDE — OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0302-2026·2026-02-18

    Pro Numb Tattoo Numbing Spray Recalled for Manufacturing Deviations

    Pro Numb Tattoo Numbing Spray (5% Lidocaine) is being recalled nationwide due to manufacturing process violations (cGMP deviations). Affected lots are J01-J14 and J55-J69 in 1 oz and 4 oz bottles.

    Product
    PRO NUMB — PRO NUMB (TATTOO NUMBING SPRAY)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0303-2026·2026-02-18

    Pro Numb tattoo numbing spray recalled for manufacturing standard violations

    Pro Numb Tattoo Numbing Spray (lot J15) is recalled nationwide due to manufacturing process deviations. The voluntary recall was initiated February 2, 2026.

    Product
    PRO NUMB SENSITIVE SKIN — PRO NUMB SENSITIVE SKIN (NUMBING SPRAY)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1329-2026·2026-02-18

    Medline medical convenience kits recalled for open seals on applicators

    Medline Industries is recalling 7,570 medical convenience kits containing BD ChloraPrep Triple Swabsticks due to potentially open seals on applicator packaging. The kits are distributed nationwide to hospital and clinical settings.

    Product
    Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, Kit SKU DT22710; 2) LINE KIT, Kit SKU DYNDA1857A; 3) PICC REMOVAL KIT, Kit SKU DYNDC1978A; 4) PORT ACCESS TRAY, Kit SKU DYNDC2367; 5) NICU CENTRAL LINE TRAY, Kit SKU DYNDC2407B; 6) CVC DRESSING
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1356-2026·2026-02-18

    Surepulse Newborn Heart Rate Monitor Cap Recalled for Incorrect Sizing Label

    Surepulse Medical recalled the VS Cap Extra Small component of its newborn heart rate monitor due to an incorrect sizing guide in the product labeling.

    Product
    Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1337-2026·2026-02-18

    Straumann Impression Post Closed Tray Recalled for Color Mismatch in Packaging

    Straumann USA is recalling 561 units of WB Impression Post Closed Tray due to incorrect impression caps in packaging. The caps are magenta instead of the intended brown color.

    Product
    WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1358-2026·2026-02-18

    FDA Recalls Surepulse Newborn Heart Rate Monitor Cap for Labeling Error

    Surepulse Medical is recalling certain newborn heart rate monitor caps due to incorrect sizing information in the labeling. The issue affects specific lot numbers distributed in the US and internationally.

    Product
    Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0304-2026·2026-02-11

    Green Lumber Natural Fuel For Men Capsules Recalled as Unapproved Drug

    Green Lumber Natural Fuel For Men capsules are recalled because FDA determined the product was marketed without required approval and contains the active ingredient tadalafil.

    Product
    Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0454-2026·2026-02-11

    Everpress Juice Spicy Lemonade Recalled for Potential Bacterial Contamination

    Everpress Juice is recalling JUICE from the Raw spicy lemonade products due to potential pathogenic bacteria from under-processing. The product was distributed in multiple states across the United States.

    Product
    JUICE from the Raw, spicy lemonade
    Category
    Food
    Distribution
    24 states
  • CriticalFDA (Food)·H-0501-2026·2026-02-11

    Swiss Chocolate Cake Mix Recalled for Undeclared Milk Allergen

    B.C. Williams Bakery Service is recalling Swiss Chocolate Cake Mix for containing undeclared milk allergen. Consumers with milk allergies should not consume this product.

    Product
    Swiss Chocolate Cake Mix; 50 lb. multi-wall, kraft, poly-lined moisture proof bags
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0460-2026·2026-02-11

    Organic Chia Seeds from Paraguay Recalled for Potential Salmonella

    Tradin Organics USA, LLC is recalling Organic Chia Seed Black from Paraguay due to potential Salmonella contamination. Product was distributed in California, Colorado, New York, and Canada.

    Product
    Organic Chia Seed Black Origin: PARAGUAY Net weight: 55.12 LBS Produced for: Tradin Organics USA, LLC, Aptos
    Category
    Food
    Distribution
    3 states