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.

16976–17000 of 88183

  • ModerateFDA (Drugs)·D-1093-2023·2023-08-30

    FDA Recalls Helix CBD Clinical Cream for Manufacturing Process Violations

    Parker Laboratories is recalling Helix CBD Clinical Cream due to manufacturing process deviations. The FDA Class II recall affects batches distributed nationwide and internationally; consumers should discontinue use and contact the manufacturer.

    Product
    Helix CBD Clinical Cream (Menthol 7.4%), packaged in a)3 gm pouches (NDC30775-054-01), b)2 fl. oz. tubes (NDC 30775-054-02), and c) 4 fl. oz. tubes (NDC 30775-054-04), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1088-2023·2023-08-30

    Rufinamide Tablets Recalled Due to Manufacturing Quality Deviation

    Aurobindo Pharma USA Inc. is recalling Rufinamide 400 mg tablets due to manufacturing quality deviations. The affected batch was released prior to approval.

    Product
    RUFINAMIDE — RUFINAMIDE (RUFINAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1089-2023·2023-08-30

    Drug manufacturer recalls Protex hand sanitizer due to manufacturing quality deviations

    Parker Laboratories is recalling Protex Foaming Hand Sanitizer due to manufacturing quality control deviations. The voluntary recall affects products distributed nationwide and internationally.

    Product
    Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%), packaged in a) 2 fl oz/60 mL Pump bottles (NDC 30775-040-02) and b)18 fl. oz./550 ml Pump Bottles (NDC 30775-040-18), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1099-2023·2023-08-30

    Unguentine Ointment Recalled Due to Manufacturing Practice Deviations

    Ecometics, Inc. is recalling Unguentine Ointment because products were not manufactured under current good manufacturing practices. The recall affects 6,660 tubes distributed nationwide.

    Product
    Unguentine Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide 6.6%), labeled as a) NET WT 1 OZ (28 g) tubes, Improved Formula, UPC 0 11169 10216 0, and b) NET WT 1 OZ (28.3g) tubes, Maximum Strength, UPC 0 11169 11250 3, Distributed by: Oakhurst Company…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1098-2023·2023-08-30

    ALCOLADO RELAMPAGO topical liniment recalled for manufacturing process violations

    Ecometics, Inc. is recalling ALCOLADO RELAMPAGO (menthol and camphor) topical liniment nationwide due to manufacturing process deviations. Products were not manufactured under current good manufacturing practices.

    Product
    ALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively, packaged in a 7 FLUID OZ (207 ml) bottles, UPC 7 18864 20102 9 and b) 16 FLUID OZ (472 ml) bottles, UPC 7 18864, 20110 4, Distributed by: The Larkspur Group, Inc., Norwalk, CT 06854.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2453-2023·2023-08-30

    Medicrea IMPIX ALIF Lumbar Fusion Devices Recalled for Packaging Defect

    Medicrea International is recalling 11 IMPIX ALIF lumbar intervertebral fusion devices distributed nationwide due to a potential packaging defect with pinholes in the device pouch.

    Product
    IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2461-2023·2023-08-30

    Cervical intervertebral fusion devices recalled for packaging defect

    Medicrea International is recalling IMPIX S cervical intervertebral fusion devices due to a potential packaging defect involving pinholes in the inner or outer pouch. No injuries have been reported.

    Product
    IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1095-2023·2023-08-30

    Prescription Drug Trandolapril and Verapamil Tablets Recalled for Subpotency

    Glenmark Pharmaceuticals is recalling Trandolapril and Verapamil Extended-Release Tablets because they are subpotent—they do not contain their full specified amount of active ingredient. The issue was found during three-month stability testing.

    Product
    TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE — TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE (TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1103-2023·2023-08-30

    Prescription Injection Recalled Due to Missing or Peeled Labels

    Baxter Healthcare Corporation recalls Bendamustine Hydrochloride injection nationwide because labels are missing or partially peeled off vials, raising the risk of medication errors.

    Product
    BENDAMUSTINE HYDROCHLORIDE — BENDAMUSTINE HYDROCHLORIDE (BENDAMUSTINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1096-2023·2023-08-30

    Blis-To-Sol Tolnaftate Liquid Recalled for Manufacturing Practice Deviations

    Ecometics, Inc. is recalling Blis-To-Sol Liquid (Tolnaftate) nationwide due to manufacturing practice violations. No illnesses have been reported.

    Product
    Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bottles, UPC 0 11169 20011 8 and b) 1.85 FLUID OZ. (54.5 mL) bottles, UPC 0 11169 20012 5, Distributed by Oakhurst Company, Levittown, NY 11756.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1456-2023·2023-08-30

    Fanta Orange Zero Sugar bottles mislabeled; contain regular sugar product

    RQA, Inc. is recalling 150 bottles of Fanta Orange Zero Sugar that were mislabeled and actually contain regular Fanta Orange with 73g of sugar instead of 0g. Affected products were distributed to retail locations in North Carolina, South Carolina, and Virginia.

    Product
    FANTA ZERO SUGAR orange 20 FL OZ (1.25 PT) 591 mL UPC 0 49000 04143 9 THE COCA-COLA COMPANY
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1094-2023·2023-08-30

    Moxifloxacin-Bromfenac Eye Drops Recalled for Subpotent Bromfenac Levels

    Imprimis NJOF, LLC is recalling 2,683 bottles of Moxifloxacin-Bromfenac eye drops nationwide because Bromfenac levels fall below the 90-110% specification (affected lots: 22DEC047 exp. 9/16/23, 23FEB057 exp. 11/24/23).

    Product
    Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC: 71384-311-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1091-2023·2023-08-30

    Helix Tri-Active Therapy Cream Recalled for Manufacturing Quality Deviations

    Parker Laboratories is voluntarily recalling Helix Tri-Active Therapy Cream due to manufacturing quality control deviations. The recall affects products with lot numbers A1221010 and A1221011, expiring December 9, 2023, distributed in the United States, Singapore, Korea, and Hong Kong.

    Product
    Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate 12.5%), packaged in a) 3 fl. oz. roll-on (NDC 30775-052-03) and b) 4 fl. oz. tube (NDC 30775-052-04) Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1090-2023·2023-08-30

    Helix Pain Relieving Cream recalled nationwide for manufacturing process violations

    Parker Laboratories is recalling Helix Pain Relieving Cream due to manufacturing process deviations. The voluntary recall affects multiple package sizes distributed nationwide and internationally.

    Product
    Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 30775-051-01), b) 3 fl. oz. roll-on (NDC 30775-051-03), c) 4 fl. oz. tubes (NDC 30775-051-04), d) 12 fl oz pump bottles (NDC 30775-051-12), e) 32 fl. oz. pump bottles (NDC 30775-051-32), f) 1 U.S. gallon…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2457-2023·2023-08-30

    Medicrea Recalls IMPIX TLIF Fusion Devices for Packaging Defects

    Medicrea International is recalling IMPIX TLIF intervertebral fusion devices due to potential packaging defects. The devices may have pinholes in the inner or outer packaging pouches.

    Product
    IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B15901006, i) B15901106, j) B15901206, k) B15901306; intervertebral fusion device - lumbar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1092-2023·2023-08-30

    Helix CBD Therapy Cream Recalled Due to Manufacturing Deviations

    Parker Laboratories voluntarily recalled Helix CBD Therapy Cream due to Current Good Manufacturing Practice deviations. The recall affects specific lot numbers distributed nationwide and internationally.

    Product
    Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-053-01), b) 2 fl. oz. tubes (NDC 30775-053-02), c) 4 fl. oz. tubes (NDC 30775-053-04), Parker Laboratories Inc., Fairfield, NJ, 07004
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1454-2023·2023-08-23

    Black melon seeds recalled for undeclared soy and wheat allergens

    Richin Trading Inc is recalling Tim Heung Yuen Black Melon Seed due to undeclared soy and wheat allergens. The product was distributed across 12 U.S. states. Consumers with these allergies should not consume the product.

    Product
    Tim Heung Yuen Black Melon Seed 6 oz., 12 oz. Ingredients: Melon Seeds, Salt, Sugar & Anise Seed Distributed By Richin Trading Inc. TEL (626) 308-3212 Allergen Warning: This repacked product was processed on shared equipments that also processed peanuts, soybean, and nuts. UPC…
    Category
    Food
    Distribution
    12 states
  • CriticalFDA (Devices)·Z-2383-2023·2023-08-23

    FDA Recalls Dialysis Catheters for Center Lumen Obstruction Risk

    Covidien is recalling MAHURKAR dialysis catheters because the center lumen may be blocked by excess silicone lubricant. This could delay treatment and cause blood clots, hemolysis, or embolism.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions REF: 8888345520HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2410-2023·2023-08-23

    Phaco Standalone Tips Recalled Due to Plastic Debris Risk

    Alcon is recalling 444,372 units of Phaco Standalone Tips worldwide because the plastic wrench included with the product can generate plastic debris when over-tightened, potentially injuring patients.

    Product
    Phaco Standalone Tips
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2373-2023·2023-08-23

    Dialysis Catheter Recall Due to Potential Lumen Occlusion

    Covidien LP is recalling MAHURKAR dialysis catheters due to excess silicone lubricant that can block the central lumen, potentially delaying treatment or causing serious complications.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, PASS Tray REF: 8888103001HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2388-2023·2023-08-23

    Dialysis Catheter Recall Due to Center Lumen Occlusion

    Covidien is recalling MAHURKAR Triple Lumen Acute Dialysis Catheters due to excessive lubricant blocking the center lumen, which may delay dialysis and cause blood clots. The recall affects 6,949 units distributed in the US and worldwide.

    Product
    MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 8888345629
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2377-2023·2023-08-23

    Acute Dialysis Catheters Recalled for Catheter Tip Occlusion

    Covidien recalls 519 MAHURKAR acute dialysis catheters (Lot 2200400292) due to excessive silicone lubricant coating the catheter tip that may cause partial or full occlusion and treatment delays.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, PASS Tray REF: 8888104004HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2387-2023·2023-08-23

    Dialysis Catheters Recalled by FDA for Tip Obstruction Risk

    Covidien is recalling MAHURKAR acute dialysis catheters because the center lumen tip may be occluded by excessive silicone-based lubricant. Obstruction could delay treatment or cause embolism and thrombosis.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit REF: 8888345611HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2406-2023·2023-08-23

    Alcon Constellation Procedure Pak recalled due to plastic debris risk

    Alcon is recalling the Constellation Procedure Pak due to reports of patient injury from plastic debris. The debris can result from over-tightening the device with the included plastic wrench.

    Product
    Constellation Procedure Pak
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1403-2023·2023-08-23

    Heinen's Cashew Butter Recalled for Undeclared Peanut and Almond

    Heinen's Fresh Ground Cashew Butter may contain undeclared peanut butter and/or almond butter. People with peanut or tree nut allergies could experience serious allergic reactions.

    Product
    Heinen's Fresh Ground Cashew Butter: packaged in plastic circle containers 1lb. Sold individually.
    Category
    Food
    Distribution
    2 states