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.

7401–7425 of 88183

  • SevereFDA (Devices)·Z-2023-2025·2025-07-02

    BD BACTEC MGIT 960 PZA Kit tuberculosis susceptibility testing recall

    Becton Dickinson is recalling BD BACTEC MGIT 960 PZA Kit due to reports of intermittent false resistance results during pyrazinamide susceptibility testing of Mycobacterium tuberculosis. The issue affects units distributed worldwide.

    Product
    BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1961-2025·2025-07-02

    MicroMyst Applicator recalled due to lack of sterility assurance

    Integra LifeSciences Corp. is recalling the MicroMyst Applicator Box of 5 due to lack of sterility assurance. The product is used with the Integra Flow Source for controlled application of two liquids.

    Product
    MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0495-2025·2025-07-02

    Azelastine Hydrochloride Ophthalmic Solution Recalled Due to Sterility

    Apotex Corp. is recalling Azelastine Hydrochloride Ophthalmic Solution, USP 0.05% due to lack of assurance of sterility. The affected batch was distributed nationwide.

    Product
    AZELASTINE HYDROCHLORIDE — AZELASTINE HYDROCHLORIDE (AZELASTINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1958-2025·2025-07-02

    Extended Tip Applicator 8CM distributed by Integra LifeSciences recalled nationwide

    Integra LifeSciences is recalling Extended Tip Applicator 8CM devices due to potentially out-of-specification endotoxin levels and lack of sterility assurance. The recall affects 6,216 units distributed across the US and internationally.

    Product
    Extended Tip Applicator, 8CM, Box of 5.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0101-2025·2025-07-02

    Isabelle's Kitchen Quinoa Tabouli Salad recalled for Salmonella contamination

    Isabelle's Kitchen, Inc. is recalling Maple Avenue Foods Quinoa Tabouli Salad due to Salmonella contamination. The product was distributed to Pennsylvania and Maryland.

    Product
    Isabelle's Kitchen, Inc, Maple Avenue Foods Quinoa Tabouli Salad , 5 lb., High density polyethylene container with sealed lid.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0491-2025·2025-07-02

    Sodium Chloride Injection Recalled for Sterility Assurance Defect

    B Braun Medical Inc. is recalling 187,656 containers of 0.9% Sodium Chloride Injection USP due to potential sterility failures caused by pinholes in finger boxes during manufacturing. The defect may allow leaks and compromise the sterile nature of the intravenous medication.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0105-2025·2025-07-02

    Crunchy Shrimp Roll recalled for Listeria monocytogenes risk

    Hy-Vee is recalling Crunchy Shrimp Roll due to potential contamination with Listeria monocytogenes. The affected product was distributed to retail locations throughout the Midwest.

    Product
    Crunchy Shrimp Roll
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·H-0066-2025·2025-07-02

    MIGHTYLICIOUS Vegan Oatmeal Coconut Cookies recalled for undeclared milk

    Mightylicious Inc. is recalling MIGHTYLICIOUS Vegan Oatmeal Coconut Cookies because they contain undeclared milk, a common allergen not listed on the label. The product was distributed to Rhode Island, Illinois, and New York.

    Product
    MIGHTYLICIOUS Vegan Oatmeal Coconut Cookies Gluten-Free, Dairy-Free, Allergen Friendly, Egg-Free, Non-GMO, Kosher, Preservative-Free Snack Option for a Guilt-Free Treat - 6.5 Oz, Stand-up pouch, 6 bags per case . UPC: -0085000955838
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0480-2025·2025-07-02

    Semaglutide pre-filled syringe recalled due to sterility concerns

    Thrive Health Solutions is recalling Semaglutide 5 mg/mL pre-filled syringes distributed nationwide because the manufacturer cannot assure the product's sterility.

    Product
    Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1960-2025·2025-07-02

    Extended Tip Applicator 8CM medical devices recalled due to sterility concerns

    Integra LifeSciences is recalling Extended Tip Applicator 8CM devices nationwide and internationally because they may contain potentially out-of-specification endotoxin levels and lack sterility assurance.

    Product
    Extended Tip Applicator 8CM, Box of 1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0481-2025·2025-07-02

    Semaglutide/Cyanocobalamin Injectable Syringes Recalled for Lack of Sterility Assurance

    Thrive Health Solutions is recalling Semaglutide/Cyanocobalamin Injectable pre-filled syringes due to lack of assurance of sterility. The affected lot was distributed nationwide.

    Product
    Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0496-2025·2025-07-02

    Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution Recall

    Apotex Corp. is recalling 6,288 bottles of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution nationwide due to lack of assurance of sterility. The affected batch (VC6058, expiration date 10/31/2025) does not meet sterility requirements for ophthalmic use.

    Product
    BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION — BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION (BRIMONIDINE TARTRATE AND TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0486-2025·2025-07-02

    Tirzepatide/Cyanocobalamin Injectable Recalled Due to Sterility Assurance Failure

    Thrive Health Solutions is recalling one lot of Tirzepatide/Cyanocobalamin Injectable pre-filled syringes due to lack of assurance of sterility. The affected product is Lot C03125A distributed nationwide.

    Product
    Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0110-2025·2025-07-02

    Hy-Vee Duo Crunchy Calif Shrimp 10Pc recalled for Listeria contamination

    Hy-Vee is recalling Duo Crunchy Calif Shrimp 10Pc due to potential contamination with Listeria monocytogenes. Affected products were distributed to retail locations throughout the Midwest.

    Product
    Duo Crunchy Calif Shrimp 10Pc
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·H-0099-2025·2025-07-02

    Greek Pasta Salad Recalled Due to Salmonella Contamination

    Isabelle's Kitchen, Inc. is recalling Greek Pasta Salad in 4.5 lb. containers due to Salmonella contamination. The recalled products were distributed to Pennsylvania and Maryland.

    Product
    Isabelle's Kitchen, Inc, Greek Pasta Salad, 4.5 lb., High density polyethylene container with sealed lid. Kings Where Inspiration Strikes, Greek Pasta Salad, 4.5 lb., High density polyethylene container with sealed lid.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·H-0113-2025·2025-07-02

    Hy-Vee Duo Crispy Veg Shrimp 10Pc recalled for Listeria monocytogenes

    Hy-Vee is recalling Duo Crispy Veg Shrimp 10Pc products due to potential contamination with Listeria monocytogenes. The affected products were distributed to retail locations throughout the Midwest.

    Product
    Duo Crispy Veg Shrimp 10Pc
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·H-0114-2025·2025-07-02

    Spicy Shrimp Poke Bowl recalled for potential Listeria contamination

    Hy-Vee is recalling Spicy Shrimp Poke Bowl products due to potential contamination with Listeria monocytogenes. The product has been distributed to retail locations throughout the Midwest.

    Product
    Spicy Shrimp Poke Bowl
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0478-2025·2025-07-02

    NAD+ Pre-Filled Syringes Recalled for Lack of Sterility Assurance

    Thrive Health Solutions is recalling NAD+ 100mg/mL pre-filled syringes (Lot #O-O8A01-25) distributed nationwide due to lack of assurance of sterility. Consumers should not use this product.

    Product
    Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0475-2025·2025-07-02

    CJC-1295 Injectable Pre-filled Syringes Recalled for Sterility Assurance

    Thrive Health Solutions is recalling CJC-1295 Injectable 6mg/15mg pre-filled syringes due to lack of assurance of sterility. The affected product was distributed nationwide.

    Product
    CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1904-2025·2025-07-02

    Broselow Pediatric Emergency Rainbow Tape recalled for incorrect dosing values

    SunMed Holdings is recalling Broselow Pediatric Emergency Rainbow Tape due to incorrect values printed on the tape that could lead to improper medication dosing and defibrillation in pediatric emergency care.

    Product
    Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0484-2025·2025-07-02

    Tirzepatide Injections recalled due to lack of sterility assurance

    Thrive Health Solutions is recalling Tirzepatide Injections 30mg/mL pre-filled syringes due to lack of assurance of sterility. The affected product was distributed nationwide.

    Product
    Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0063-2025·2025-07-02

    Shore Lunch Breading and Batter Mix Recalled for Undeclared Milk

    Homegrown Family Foods LLC is recalling Shore Lunch Breading & Batter Mix Oven Style because it contains undeclared milk, a common allergen. The product was distributed across multiple Midwestern and East Coast states.

    Product
    Shore Lunch BREADING & BATTER MIX OVEN STYLE A savory, crunchy coating perfect for fish, pork and chicken. Net Wt 6oz (170g) UPC 0 24739 12000 6 Summit Hill Foods Rome, GA 30162
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·H-0111-2025·2025-07-02

    Hy-Vee Duo Crispy Calif Shrimp recalled for Listeria contamination

    Hy-Vee is recalling Duo Crispy Calif Shrimp 10Pc due to potential contamination with Listeria monocytogenes. Affected cases were distributed to retail locations throughout the Midwest.

    Product
    Duo Crispy Calif Shrimp 10Pc
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0494-2025·2025-07-02

    Ketorolac Tromethamine Ophthalmic Solution Recalled for Sterility Risk

    Apotex Corp. is recalling Ketorolac Tromethamine Ophthalmic Solution 0.5% due to lack of assurance of sterility. The recall affects 87,840 bottles distributed nationwide.

    Product
    KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide