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.

20901–20925 of 88183

  • HighFDA (Drugs)·D-0124-2023·2023-01-18

    Compounded Injectable Medication Recalled Due to Sterility Assurance Concerns

    Northern VA Compounders is recalling QuadMix Injectable due to lack of assurance of sterility. The FDA Class II recall affects compounded injectable medication distributed nationwide.

    Product
    QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg/40mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0262-2023·2023-01-18

    Take & Toast Sourdough Waffles Recalled for Undeclared Milk and Wheat Allergens

    Take & Toast Sourdough Waffles (UPC 44216-26602) distributed in Texas are being recalled because the product label does not include the common names for milk and wheat allergens. Consumers with allergies to these ingredients should not consume this product.

    Product
    Take & Toast Sourdough Waffles UPC 44216-26602 packaged in clear flexible plastic bag
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0106-2023·2023-01-18

    Compounded TriMix Injectable Recalled for Lack of Sterility Assurance

    Northern VA Compounders is recalling 750 vials of TriMix Original injectable nationwide due to lack of assurance of sterility. Patients should discontinue use and consult their healthcare provider.

    Product
    TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0923-2023·2023-01-18

    Adult Craniotome Attachment Recalled for Ball Bearing Failure Risk

    The ANSPACH CRANI-A Adult Craniotome Attachment is recalled because ball bearings can separate during use or removal, creating an intra-operative hazard. The Anspach Effort, Inc. is recalling 6,059 units distributed nationwide and internationally.

    Product
    6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-P Intended for cutting and shaping bone including the spine and cranium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0117-2023·2023-01-18

    Injectable Compounded Drug Recall Due to Lack of Sterility Assurance

    Northern VA Compounders PLLC is recalling 525 vials of TriMix Plus 001 injectable medication nationwide due to lack of assurance of sterility. Patients who received this product should consult their healthcare provider.

    Product
    TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0920-2023·2023-01-18

    Large Craniotome Attachment Ball Bearings Risk Loosening During Surgery

    Ball bearings in The Anspach Effort's 7.5 cm Large Craniotome Attachment may come loose during removal or surgery, potentially causing serious patient injury. 6,059 units are affected worldwide.

    Product
    7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-L Intended for cutting and shaping bone including the spine and cranium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0119-2023·2023-01-18

    Methylcobalamin Injection Recalled Due to Lack of Sterility Assurance

    Northern VA Compounders PLLC is recalling Methylcobalamin Injection Solution (12.5mg/ml, 2 mL vials) due to lack of assurance of sterility. The affected lot was distributed nationwide.

    Product
    Methylcobalamin Injection Solution, 12.5mg/ml, packaged in 2 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0914-2023·2023-01-18

    Medtronic Vanta Seqenita LT Neurostimulation Device Recalled for Software Anomalies

    Medtronic is recalling 1,337 Vanta Seqenita LT neurostimulation programmer units worldwide due to software anomalies that generate specific error messages in the clinician application.

    Product
    Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900D
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0246-2023·2023-01-18

    True Goodness Yogurt Alternative Recalled for Almond-Based Mislabeling

    Meijer is recalling 1,590 tubs of True Goodness Yogurt Alternative because the product contains almond but is mislabeled as oat-based. This poses a risk to consumers with tree nut allergies.

    Product
    True Goodness by Meijer Oat-Based Plain Yogurt Alternative, 24oz plastic tub, UPC: 7-13733-03918-5
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0953-2023·2023-01-18

    Medtronic RadiaLux Lighted Retractor recalled for defective sterile pouch seal

    Medtronic is recalling 2,317 RadiaLux Lighted Retractor units due to defects in the sterile pouch seal that increase contamination risk and potential post-operative infection.

    Product
    RadiaLux Lighted Retractor (Pink), REF: 50-101-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0228-2023·2023-01-18

    TOHATO Nagewa Snack Products Recalled for Undeclared Milk Allergen

    TOHATO Nagewa Snack Salty Taste products are recalled for containing undeclared milk allergen (sodium caseinate). The recall affects 11,989 units distributed to Daiso stores in California, Washington, Nevada, Texas, New York, New Jersey, and Canada.

    Product
    TOHATO Nagewa Snack Salty Taste 27g and 73g units UPC numbers: 4901940112036 & 4901940112005 Product sold individually, shipped 12 units per case Exported by: DAISO INDUSTRIES CO., LTD. 1-4-14 Saljo-Yoshiyukihigashi, Higashihiroshima-City, Hiroshima 739-8501 JAPAN
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0255-2023·2023-01-18

    Beijing Hawthorne Candy Recalled Due to Undeclared Sulfites

    Northern Food I/E Inc. is recalling Beijing Hawthorne Candy due to undeclared sulfites. The product contains 7.32 mg sulfites per serving and has been distributed to 24 states.

    Product
    Beijing Hawthorne Candy
    Category
    Food
    Distribution
    24 states
  • HighFDA (Drugs)·D-0113-2023·2023-01-18

    TriMix Injection Recall Due to Lack of Sterility Assurance

    Northern VA Compounders PLLC is recalling TriMix Injection nationwide due to lack of assurance of sterility. The affected compounded injectable product comes in 2.5 mL vials with lot number 11142022@12.

    Product
    TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0102-2023·2023-01-18

    Mitomycin Injection Solution Recalled Due to Lack of Sterility Assurance

    Mitomycin Injection Solution manufactured by Northern VA Compounders PLLC is being recalled because sterility cannot be assured. Patients receiving this product should contact their healthcare provider.

    Product
    Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0251-2023·2023-01-18

    Sanders Milk Chocolate Sea Salt Pecan Cluster Recalled for Brush Bristles

    Sanders Candy LLC recalls Sanders Milk Chocolate Sea Salt Pecan Cluster due to foreign material—pieces of cleaning brush bristles—found in the product. The recall affects nearly 1 million units distributed nationwide and in Canada.

    Product
    Sanders Milk Chocolate Sea Salt Pecan Cluster: 0-35900-25550-2 .5OZ Individual Wrapped 0-35900-27486-2 25OZ Tub 0-35900-30971-7 18OZ Tub 0-35900-30170-4 7OZ Pouch
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0253-2023·2023-01-18

    Sanders Dark Chocolate Maple Sea Salt Caramel Recalled for Foreign Material

    Sanders Candy LLC is recalling Sanders Dark Chocolate Maple Sea Salt Caramel due to brush bristles found in the product. Consumers should not consume affected units.

    Product
    Sanders Dark Chocolate Maple Sea Salt Caramel: No UPC 6oz. foil bag
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0098-2023·2023-01-18

    Rifampin Capsules Recalled Due to Failed Quality Specifications

    RemedyRepack Inc. is recalling Rifampin Capsules, 300 mg, due to failed impurities and degradation specifications. The affected product was distributed to a single pharmacy account in Pennsylvania.

    Product
    Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC 68180-0659-07, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, Repackaged NDC 70518-2404-00.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0126-2023·2023-01-18

    TriMix Injection Recalled Due to Lack of Sterility Assurance

    Northern VA Compounders is recalling TriMix Injection due to inability to assure the product meets sterility standards required for injectable medications. The recall affects 2 vials distributed nationwide.

    Product
    TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0933-2023·2023-01-18

    Cystoscopy kits recalled for potential sterility breach from packaging defects

    Henry Shein CYSTO SET UP PACK units are being recalled due to potential pinhole leaks in the outer bag that could compromise the sterility of the kit.

    Product
    Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0921-2023·2023-01-18

    Adult Craniotome Ball Bearing Separation Risk During Neurosurgery

    The Anspach Adult Craniotome Large attachment ball bearings may separate during surgical removal or intra-operatively, potentially causing serious patient injury.

    Product
    Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0942-2023·2023-01-18

    Stradis Healthcare Neonatal PICC Trays recalled for potential sterility breach

    Stradis Healthcare is recalling 2,500 units of Neonatal PICC Trays due to potential pinhole leaks in the outer bag that could compromise sterility. The affected trays were distributed nationwide.

    Product
    Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis Healthcare, Distributed by Med Alliance Group
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0939-2023·2023-01-18

    HCT 6 CC Syringe Kits recalled for potential sterility breach from packaging leaks

    Stradis Healthcare recalls 76,260 HCT 6 CC Syringe Kits due to potential pinhole leaks in outer packaging that may compromise sterility. The kits were distributed nationwide.

    Product
    HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0121-2023·2023-01-18

    TriMix Injection Recalled Nationwide for Lack of Sterility Assurance

    Northern VA Compounders recalls TriMix Injectable due to lack of sterility assurance in 8 vials distributed nationwide. Patients should consult their healthcare provider about affected doses.

    Product
    TriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0252-2023·2023-01-18

    Sanders Dark Chocolate Peppermint Recalled for Cleaning Brush Bristles

    Sanders Dark Chocolate Peppermint Sea Salt Caramel is recalled nationwide and in Canada due to contamination with cleaning brush bristles. Products with Best By dates from October and December 2023 are affected.

    Product
    Sanders Dark Chocolate Peppermint Sea Salt Caramel: UPC 0-35900-30857-4 18OZ Tub UPC 0-35900-30919-9 32OZ Tub
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0100-2023·2023-01-18

    Prescription Rifampin Capsules Recalled for Failed Impurity Specifications

    Lupin Pharmaceuticals is recalling Rifampin Capsules (300 mg) nationwide due to failed impurity and degradation specifications found during stability testing. Lot A200171 (exp. 12/2023) is affected, with over 16,000 bottles distributed.

    Product
    RIFAMPIN — RIFAMPIN (RIFAMPIN)
    Category
    Drug
    Distribution
    Distributed nationwide