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.

14526–14550 of 27263

  • HighFDA (Drugs)·D-0065-2024·2023-10-25

    Foscarnet Sodium Injectable Recalled Due to Lack of Sterility Assurance

    Pine Pharmaceuticals is recalling Foscarnet Sodium 2.4mg/0.1 mL injectable syringes nationwide due to lack of assurance of sterility. No illnesses or injuries have been reported.

    Product
    Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0064-2024·2023-10-25

    Compounded Intranasal Lidocaine-Oxymetazoline Solution Recalled Due to Sterility Assurance

    Pine Pharmaceuticals is recalling 860 syringes of intranasal lidocaine-oxymetazoline solution distributed nationwide due to lack of sterility assurance. Lot 67808 expired 10/23/2023.

    Product
    Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0044-2024·2023-10-25

    Sun Pharmaceutical Bupropion Extended-Release Tablets Recalled for Failed Dissolution

    Sun Pharmaceutical is recalling Bupropion Hydrochloride Extended-Release Tablets (150 mg), lot HAD0360A, due to failed dissolution specifications. The 144 bottles were distributed nationwide and may not dissolve at the intended rate.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0119-2024·2023-10-25

    MEDLINE Electrosurgical Instruments Recalled for Incomplete Packaging Seals

    MEDLINE INDUSTRIES is recalling ReNewal Ligasure Sealer/Divider electrosurgical instruments due to incomplete seals on packaging trays. The recall affects 268 units distributed in the United States.

    Product
    MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF4418CR. electrosurgical instrument
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0121-2024·2023-10-25

    SenSight Connector Plug Recalled for Use By Date Label Discrepancy

    Medtronic Neuromodulation is recalling 65 units of the SenSight Connector Plug, Model B31061, due to a discrepancy in the Use By Date printed on the device label. The company is requesting return of affected units.

    Product
    SenSight Connector Plug, Model Number B31061.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0118-2024·2023-10-25

    Medline ReNewal Ligasure Maryland Jaw Sealer devices recalled for incomplete packaging seals

    Medline is recalling 58 units of ReNewal Ligasure Maryland Jaw Sealer electrosurgical instruments due to incomplete seals on packaging trays that may allow contamination during reprocessing.

    Product
    MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible with FT10 Generator, REF LF1944CR. electrosurgical instrument
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0045-2024·2023-10-25

    Over-the-counter drugs from Family Dollar recalled for improper storage

    Dollar Tree Distribution recalled approximately 4.3 million over-the-counter drug products sold by Family Dollar stores nationwide after discovering they were stored outside of labeled temperature requirements.

    Product
    Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0043-2024·2023-10-25

    Ophthalmic Solution Recalled Due to Subpotent Ketorolac Levels

    MYDRIATIC-4 ophthalmic solution is being recalled because ketorolac levels fell below the required 90-110% specification. The product was distributed to physician offices nationwide.

    Product
    MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0117-2024·2023-10-25

    Electrosurgical Devices Recalled for Incomplete Packaging Tray Seal

    Medline is recalling 11 reprocessed Covidien LigaSure and Ethicon Harmonic electrosurgical devices due to incomplete seals on their packaging trays.

    Product
    MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF1844CR. electrosurgical instrument
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Food)·F-0287-2024·2023-10-18

    Quaker Pancakes with Whole Grain Oats Recalled for Undeclared Soy Allergen

    Comercializadora Pepsico Mexico recalls Quaker Pancakes with Whole Grain Oats due to undeclared soy allergen. The product contains soy not listed on the label, creating a health risk for consumers with soy allergies.

    Product
    QUAKER PANCAKES WITH WHOLE GRAIN OATS, NET WT 15.97OZ (1LB)
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0011-2024·2023-10-18

    Ginger Snap Milk Chocolate recalled for undeclared peanut allergen

    Dick Taylor Inc is recalling Ginger Snap Milk Chocolate due to undeclared peanut allergen. People with peanut allergies may experience serious allergic reaction if they consume this product.

    Product
    Ginger Snap Milk Chocolate, 2 oz wrapped
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0028-2024·2023-10-18

    FDA Recalls Fresenius 2008T Hemodialysis Systems Due to PCBA Leaching

    Fresenius Medical Care is recalling 703 units of the Fresenius 2008T Hemodialysis System nationwide due to potential PCBA (printed circuit board assembly) leaching from machine tubing.

    Product
    2008T Hemodialysis SYS, with CDX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0007-2024·2023-10-18

    Syringes with Luer Lock Recalled for Blood Backfill and Foreign Material Risk

    Fresenius Medical Care is recalling 3ML syringes with Luer Lock due to potential blood backfill leakage and foreign material contamination. The recall affects 124,773 boxes distributed nationwide.

    Product
    3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0032-2024·2023-10-18

    Hemodialysis Machines Recalled Due to Potential PCBA Leaching

    Fresenius Medical Care is recalling 733 hemodialysis machines nationwide due to potential printed circuit board material leaking from tubing.

    Product
    2008T HD SYS. CDX BLUESTAR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0030-2024·2023-10-18

    2008T Hemodialysis System recalled for potential PCBA leaching from tubing

    Fresenius Medical Care is recalling 733 units of the 2008T Hemodialysis System due to potential leaching of printed circuit board material from machine tubing. Patients using affected devices should contact their healthcare provider.

    Product
    2008T Hemodialysis System w/Bibag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0033-2024·2023-10-18

    Hemodialysis machines recalled for potential PCBA leaching from tubing

    Fresenius Medical Care is recalling 733 units of 2008T HD hemodialysis machines nationwide due to potential PCBA leaching from tubing. The FDA classified this as a Class I recall.

    Product
    2008T HD SYS. CDX W/BIBAG BLUESTAR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0031-2024·2023-10-18

    Medical device manufacturer recalls hemodialysis machines for potential PCBA leaching

    Fresenius Medical Care is recalling 733 units of the 2008T GEN 2 Bibag hemodialysis machine due to potential printed circuit board assembly material leaching from tubing. All affected units were distributed domestically.

    Product
    2008T GEN 2 Bibag without CDX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0005-2024·2023-10-18

    FDA Recalls Fresenius 10mL Luer Lock Syringes Due to Leakage and Foreign Material

    Fresenius Medical Care is recalling 10mL syringes nationwide due to potential blood backfill leakage and foreign material. The recall affects 124,773 boxes of the devices.

    Product
    10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0042-2024·2023-10-18

    FDA recalls BREXAFEMME tablets due to cross-contamination with ezetimibe

    The FDA is recalling BREXAFEMME antifungal tablets due to potential cross-contamination with ezetimibe during manufacturing, with two lot numbers distributed nationwide.

    Product
    BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc., Jersey City, NJ 07302 NDC 75788-115-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0034-2024·2023-10-18

    Hemodialysis machines recalled due to potential circuit board material leaching

    Fresenius Medical Care is recalling 733 units of 2008T hemodialysis systems nationwide due to potential leaching of printed circuit board assembly material from tubing. No illnesses or injuries have been reported.

    Product
    2008T HD SYS. W/O CDX BLUESTAR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0035-2024·2023-10-18

    Hemodialysis Systems Recalled for Potential PCBA Tubing Leaching

    Fresenius Medical Care is recalling 733 hemodialysis machines nationwide due to potential leaching of circuit board material from tubing. Affected equipment may contaminate blood or dialysate during treatment.

    Product
    2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0006-2024·2023-10-18

    10ML Syringe Luer Lock Recalled for Potential Blood Backfill Leakage

    Fresenius Medical Care is recalling 124,773 boxes of 10ML Syringe Luer Lock syringes due to potential blood backfill leakage and foreign material contamination.

    Product
    10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0029-2024·2023-10-18

    Hemodialysis machines recalled for potential printed circuit board contamination

    Fresenius Medical Care is recalling 733 2008T Hemodialysis Systems without CDX due to potential PCBA leaching from tubing. This FDA Class I recall affects units distributed nationwide.

    Product
    2008T Hemodialysis System without CDX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0007-2024·2023-10-18

    LuLu Chinese Express Korean Noodles Recalled for Undeclared Egg Allergen

    LuLu Chinese Express Korean Noodles (Japchae) with Vegetables are being recalled due to undeclared egg allergen. The 54 containers distributed in Missouri may pose a health risk to consumers with egg allergies.

    Product
    LuLu Chinese Express Korean Noodles (Japchae) w/ Vegetables. Net Wt 16oz.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0092-2024·2023-10-18

    Cardinal Health recalls Presource Fistulogram Packs with defective components

    Cardinal Health is recalling Presource Fistulogram Packs containing recalled components including equipment drapes and table covers. Approximately 13,351 sterile packs distributed across 33 US states and Canada are affected.

    Product
    Presource Fistulogram Pack, Cat. SANOCFGHHA, Hartford Hospital, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide