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.

6626–6650 of 26961

  • ModerateFDA (Drugs)·D-0305-2025·2025-04-09

    Sterile ophthalmic solution recalled for subpotent drug strength

    Imprimis NJOF is recalling 2,822 bottles of sterile ophthalmic solution because stability testing showed subpotent drug strength below specifications.

    Product
    Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1503-2025·2025-04-09

    Laboratory diagnostic reagent distributed with incorrect calibration value on package label

    Fisher Diagnostics is recalling Pacific Hemostasis Thromboplastin-D reagent (1,699 units) due to an incorrect International Sensitivity Index (ISI) value printed on the box. No illnesses or injuries have been reported.

    Product
    Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1513-2025·2025-04-09

    Surgical Suture Needles Recalled Due to Manufacturing Defect

    Ethicon Endo Surgery recalls PDS PLUS VIO surgical sutures with needles due to silicone curing defects during manufacturing. 792 units were distributed worldwide.

    Product
    PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0304-2025·2025-04-09

    Tolterodine Tartrate Extended-Release Capsules Recalled for Failed Dissolution

    Tolterodine Tartrate Extended-Release Capsules, 2 mg (Lot T05393) are being recalled because they failed dissolution specifications. The capsules may not dissolve as intended.

    Product
    TOLTERODINE TARTRATE — TOLTERODINE TARTRATE (TOLTERODINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0309-2025·2025-04-09

    Prescription Antipsychotic Drug Recalled for Manufacturing Impurity

    Glenmark Pharmaceuticals is recalling Chlorpromazine Hydrochloride Tablets due to a manufacturing quality deviation involving an impurity above recommended limits.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1396-2025·2025-04-02

    CVAC Aspiration System Requires Labeling Update for Pressure Risk

    The CVAC Aspiration System requires a labeling update to add safety instructions for high-viscosity kidney fluid. Continuing fluid inflow without adequate outflow can create dangerous intrarenal pressure imbalances.

    Product
    CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1390-2025·2025-04-02

    Shiley Adult Tracheostomy Tubes Recalled Due to Flange Disconnection Risk

    Covidien is recalling 780 Shiley Adult Flexible Tracheostomy Tubes because the flange may disconnect from the outer cannula, potentially causing respiratory failure, aspiration, or death.

    Product
    Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0673-2025·2025-04-02

    Wangzhine Hot Pot Sauce Recalled for Undeclared Wheat and Soy Allergens

    Wangzhine branded Hot Pot Sauce (SPICY) is recalled for undeclared Wheat and Soy allergens. The affected product poses a risk to consumers with these allergies.

    Product
    Wangzhine branded Hot Pot Sauce (SPICY); Net Weight: 160 Grams, 5.64OZ; 36 units/case; UPC# 6907592001382
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0300-2025·2025-04-02

    SinuCleanse Nasal Saline Packets Recalled for Bacterial Contamination

    SinuCleanse Premixed Saline Packets sold nationwide are being recalled due to contamination with Staphylococcus aureus, a bacterium that can cause infection.

    Product
    SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash System, 60-count All Natural USP Grade Saline Packets, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00103 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0301-2025·2025-04-02

    SinuCleanse Neti Pot Nasal Wash System Recalled for Bacterial Contamination

    Ascent Consumer Products Inc. is recalling SinuCleanse Soft Tip Neti Pot Nasal Wash System due to bacterial contamination with Staphylococcus aureus. Consumers should stop using this product immediately.

    Product
    SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 kettle style Neti Pot, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0672-2025·2025-04-02

    Wangzhine Hot Pot Sauce recalled for undeclared wheat and soy allergens

    Liaoning Cheng Da (USA) Inc is recalling Wangzhine branded Hot Pot Sauce due to undeclared wheat and soy allergens. The recall affects 3,650 cases distributed to 5 direct accounts in California.

    Product
    Wangzhine branded Hot Pot Sauce; Net Weight: 160 Grams, 5.64OZ; 36 units/case; UPC# 6907592001375
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0669-2025·2025-04-02

    Glicks Dark Chocolate Conettos recalled for undeclared milk allergen

    Kenover Marketing Corp. is recalling Glicks Dark Chocolate Conettos due to an undeclared milk allergen. The product was distributed across multiple states. Consumers with milk allergies should not consume it.

    Product
    Glicks Dark Chocolate Conettos, 2.47 oz., Plastic Bag, 24 packages per case
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-0299-2025·2025-04-02

    SinuCleanse Nasal Wash System Recalled for Bacterial Contamination

    Ascent Consumer Products Inc. is recalling SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System nationwide due to bacterial contamination with Staphylococcus aureus. Affected lot number is 024122661Al with expiration date 12/2027.

    Product
    SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 Soft tip Squeeze Bottle, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0663-2025·2025-04-02

    Jinga Glass Noodles Recalled for Undeclared Egg Allergen

    HAR Maspeth Corp. is recalling Jinga Glass Noodles for containing undeclared egg. The product, distributed across the Northeast and Midwest, poses a risk to consumers with egg allergies.

    Product
    Jinga Glass Noodles with vegetables 8 oz. and 12 oz.
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-1425-2025·2025-04-02

    Lap Pack Convenience Kits Recalled for Sterility Assurance Concerns

    American Contract Systems is recalling 500 Lap Pack - 170307 convenience kits distributed in Arizona due to sterility assurance concerns with procedure trays.

    Product
    Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number: BHLP62H Software Version: N/A Product Description: Convenience Kit Component: No
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0294-2025·2025-04-02

    Testosterone Gel Recalled Nationwide Due to Benzene Contamination

    Strides Pharma is recalling Testosterone Gel 1% nationwide due to the presence of benzene, a toxic substance. Patients should contact their healthcare provider about alternative treatment options.

    Product
    TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1430-2025·2025-04-02

    Pressure Monitoring Lines Recalled for Manufacturing Defect in Luer Fittings

    Medline Industries is recalling namic medical convenience kits containing Pressure Monitoring Lines with defective female luer fittings manufactured with excess material. The defect could impair device function.

    Product
    namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical convenience kit, REF 600605710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1444-2025·2025-04-02

    Medline surgical procedure kits recalled for syringe leaks and breakage

    Medline procedure kits containing plastic syringes are recalled due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The affected kits were distributed nationwide in the US and Canada.

    Product
    Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2) ABD CLOSURE PACK, Pack Number DYNJ56987B; 3) ADULT PERC PACK-LF, Pack Number PHS170994005A; 4) BASIC PACK, Pack Number DYNJ54836B; 5) BASIC PACK, Pack Number DYNJ58678A; 6) BASIC PACK, Pa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1448-2025·2025-04-02

    Medline C-section procedure kits recalled for syringe quality defects

    Medline is recalling C-section procedure kits because plastic syringes in the kits may leak or break. The defect was identified in connection with an FDA safety alert and poses a potential risk to patient health.

    Product
    Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622; 2) C SECTION PACK, Pack Number DYNJ48483B; 3) C SECTION PACK, Pack Number DYNJ61573; 4) C SECTION PACK, Pack Number DYNJ66801; 5) C SECTION PACK-LF, Pack Number DYNJ0367951P; 6) C SECTION PACK-LF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1467-2025·2025-04-02

    Checkpoint Guardian Intraoperative Lead: Potential Electrical Exposure Risk

    Adhesive may not fully encapsulate metallic components on Checkpoint Guardian Intraoperative Leads, creating potential for electrical current leakage. This could cause inconsistent muscle responses and incorrect surgical actions.

    Product
    Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Medium Model/Catalog Number: REF# 9525 (Medium) Product Description: The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for providing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1453-2025·2025-04-02

    Medline Procedure Kits with Defective Syringes Recalled for Leak and Breakage Risk

    Medline is recalling C SCOPE Disposable Kits due to plastic syringes affected by quality issues including leaks and breakage that may pose a risk to patient health. The recall affects kits distributed nationwide in the US and Canada.

    Product
    Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613034700, 2) C SCOPE DISPOSABLE KIT, Pack Number 613034702
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1429-2025·2025-04-02

    Medline Arterial Pressure Monitoring Line Kits Recalled for Manufacturing Defect

    Medline is recalling certain arterial pressure monitoring line kits due to excess material on female luer fittings. The affected kits were distributed worldwide, including the United States.

    Product
    namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1428-2025·2025-04-02

    Medline Namic Convenience Kits Pressure Monitoring Lines Recalled for Manufacturing Defect

    Medline is recalling 4400 Namic convenience kits with Pressure Monitoring Lines because the female luer fittings were manufactured with excess material near the fluid pathway.

    Product
    namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1455-2025·2025-04-02

    Contact lenses for astigmatism recalled due to incorrect cylinder power

    CooperVision is recalling multiple brands of daily disposable toric contact lenses manufactured with incorrect cylinder power in certain lot codes. Users of affected lenses should stop wearing them and contact their eye care provider.

    Product
    Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1 Day Premium For Astigmatism, REVEAL 1-DAY TORIC, Vision Source Reveal Toric, Voyant 1-Day Premium Toric. Brand Names (OUS only): CADENCE DELUXE 1-DAY TORIC, DUB
    Category
    Medical Device
    Distribution
    15 states