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.

16851–16875 of 27263

  • ModerateFDA (Drugs)·D-0824-2023·2023-06-07

    Akorn Lidocaine Oral Solution Recalled Due to Manufacturing Compliance Deviations

    Akorn Operating Company is recalling all lots of Lidocaine Hydrochloride Oral Topical Solution 2% distributed nationally because the firm ceased operations and could not complete required stability studies.

    Product
    Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0842-2023·2023-06-07

    Ropivacaine Hydrochloride Injection Recalled Due to Incomplete Stability Studies

    Akorn, Inc. is recalling all lots of Ropivacaine Hydrochloride Injection USP 0.5% nationwide due to incomplete stability studies. The manufacturer ceased operations and could not continue required FDA testing.

    Product
    Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0791-2023·2023-06-07

    Cetrorelix Acetate Injectable Recalled Due to Manufacturing Deviations

    Akorn, Inc. recalls all lots of Cetrorelix Acetate for Injection due to manufacturing process deviations. The company went out of business and could not complete required stability testing.

    Product
    Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which contains: 1 vial with lyophilized powder for reconstitution, 1 pre-filled syringe with diluent, 1 20-gauge needle, 1 27-gauge needle, Sterile - For subcutaneous use only, Rx Only, Manufacture
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0833-2023·2023-06-07

    Olopatadine HCl Eye Drops Recalled for Manufacturing Quality Deviations

    Akorn, Inc. is recalling all lots of Olopatadine HCl Ophthalmic Solution, USP 0.1% eye drops due to Current Good Manufacturing Practice deviations. The manufacturer discontinued required stability studies after ceasing operations.

    Product
    Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0822-2023·2023-06-07

    Lidocaine Ointment USP Recalled Due to Manufacturing Process Deviations

    Akorn, Inc. recalls all lots of Lidocaine Ointment USP 5% (1 1/4 oz tubes) distributed nationwide due to CGMP deviations. The manufacturer could not complete required stability studies after closing operations.

    Product
    Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0855-2023·2023-06-07

    Vitamin D Supplement Drops Recalled Due to Manufacturing Practice Violations

    Akorn, Inc. is recalling Vitamin D Supplement Drops (400 IU, Cherry Flavored, 50mL) distributed nationwide because the firm ceased operations and could not complete required stability studies.

    Product
    Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0799-2023·2023-06-07

    Dicyclomine Hydrochloride Injectable Drug Recalled for Manufacturing Quality Deviations

    Akorn, Inc. is recalling all lots of Dicyclomine Hydrochloride Injection USP nationwide due to Current Good Manufacturing Practice deviations. The firm went out of business and could not complete required stability studies.

    Product
    Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0864-2023·2023-06-07

    Tropicamide Ophthalmic Solution Recalled by Akorn for CGMP Deviations

    Akorn Operating Company is recalling all lots of Tropicamide Ophthalmic Solution 0.1% nationwide due to Good Manufacturing Practice (CGMP) deviations. The firm ceased operations and could not complete required stability studies.

    Product
    Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0848-2023·2023-06-07

    Akorn Antibiotic Suspension Recalled Due to CGMP Deviations and Unverified Stability

    Akorn recalls all lots of Sulfamethoxazole & Trimethoprim Oral Suspension (200mg/40mg per 5mL) nationwide due to inability to complete required stability studies after the company ceased operations.

    Product
    Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL bottles, Cherry Flavor, Rx only, Manufactured by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0819-2023·2023-06-07

    Levofloxacin Oral Solution Recalled Due to Manufacturing Compliance Issues

    Akorn, Inc. recalled all lots of Levofloxacin Oral Solution due to the company going out of business and being unable to continue required stability studies. Patients currently taking this medication should contact their healthcare provider.

    Product
    Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL bottles, and c) 480 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1618-2023·2023-05-31

    Pediatric Ventricular Assist Device Blood Pumps Recalled for Potential Membrane Disruption

    BERLIN HEART GMBH recalls EXCOR Pediatric Ventricular Assist Device Blood Pumps due to potential disruption in triple-layer membranes. The 335 affected units were distributed to multiple US states and Canada.

    Product
    EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood pump), P50P-001 (50 ml blood pump); P60P-001 (60 ml blood pump). Recall occurred in 2018, and was r
    Category
    Medical Device
    Distribution
    16 states
  • CriticalFDA (Food)·F-0925-2023·2023-05-31

    Lay's Potato Chips Recalled for Undeclared Milk Allergen

    Frito-Lay is recalling Lay's Classic Potato Chips due to undeclared milk. The recall affects specific products distributed in Connecticut, Massachusetts, Maine, and New Hampshire.

    Product
    Lay s Classic Party Size Potato Chips 13 oz. (368.5 g) UPC 028400310413 packaged in a yellow flexible bag and Lay s Classic Mix and Match Potato Chips 15 5/8 oz (442.9 g) UPC 0028400720151 packaged in a yellow flexible bag
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1594-2023·2023-05-31

    COVID-19 At-Home Test Kits Recalled for Bacterial Buffer Contamination

    SD Biosensor is recalling 2,712,767 Pilot COVID-19 At-Home Test kits nationwide due to bacterial contamination in the liquid buffer component. Users may notice an odor from affected kits.

    Product
    Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0955-2023·2023-05-31

    Safeway Oatmeal Raisin Cookies Recalled for Undeclared Peanut and Soy Allergens

    Safeway brand Oatmeal Raisin Cookies (18 count) are being recalled due to undeclared peanut and soy allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    Oatmeal Raisin Cookies 18 Count, Safeway brand, packaged in a clear plastic hinged container, Net wt. 14oz. UPC 0 227862 70500 7. Distributed by Safeway Inc. Pleasanton, CA 94588. The Oatmeal Raisin scale label does include allergen advisory statement: Made in a facility that
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0921-2023·2023-05-31

    Multiple kale greens products recalled for possible Listeria contamination

    Lancaster Foods LLC is recalling ROBINSON FRESH and LANCASTER kale greens products due to possible Listeria monocytogenes contamination. Affected products have a best-by date of May 1, 2023, and were distributed in MA, MD, PA, NY, NJ, and VA.

    Product
    ROBINSON FRESH KALE GREENS, NET WT 16 OZ, UPC:0-95829-60015. Packaged in sealed plastic bags, 8 in a case. ROBINSON FRESH KALE GREENS NET WT 32 OZ UPC: 0-95829-60016-6. Packaged in sealed plastic bags, 8 in a case. LANCASTER Chopped Kale NET WT 4 OZ CHOPPED KALE. Packaged in
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0931-2023·2023-05-31

    Tuna Salad Cup Recalled Due to Undeclared Egg Allergen

    Ultra Tuna Salad Cup (DishD'Lish brand) distributed in Washington is recalled because the label does not declare egg as an ingredient. Consumers with egg allergies should not consume this product.

    Product
    Ultra Tuna Salad Cup, brand DishD'Lish, packaged in plastic cup. Label declares Housemade Albacore Tuna Salad, Arugula, Cucumber and Cherry Tomatoes.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0922-2023·2023-05-31

    Giant Curly Leaf Spinach Recalled for Possible Listeria Contamination

    Lancaster Foods LLC is recalling Giant Curly Leaf Spinach due to possible Listeria monocytogenes contamination. The product was distributed in MA, MD, PA, NY, NJ, and VA.

    Product
    GIANT CURLY LEAF SPINACH, 12 /8 OZ, UPC: 6-88267-09813-0. Packaged in sealed plastic bags, 12 in a case.
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0923-2023·2023-05-31

    Collard Greens Recalled Due to Possible Listeria Contamination

    Lancaster Foods is recalling Robinson Fresh and Giant collard greens due to possible contamination with Listeria monocytogenes. Affected products distributed in the Northeast and Mid-Atlantic should not be consumed.

    Product
    ROBINSON FRESH COLLARD GREENS, 16 OZ, UPC:0-95829-60006-7. Packaged in sealed plastic bags, 8 in a case. GIANT COLLARD GREENS, 16 OZ, UPC: 6-88267-05311-5. Packaged in sealed plastic bags, 8 in a case.
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0933-2023·2023-05-31

    House Made Tarragon Chicken Salad Sandwich—undeclared egg and wheat allergens

    FDA recalls House Made Tarragon Chicken Salad Sandwich by DishD'Lish because the label fails to declare egg and wheat, which are common allergens present in the product.

    Product
    House Made Tarragon Chicken Salad Sandwich, brand DishD'Lish. The label declares House Roasted Chicken Breast, Herbs, Fresh Tarragon, Arugula, Mayonnaise, and Whole Grain Bread.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0928-2023·2023-05-31

    Cole Slaw Recalled Due to Undeclared Egg and Soy Allergens

    Washington Crab & Seafood Company recalls 463 cases of 16-ounce Cole Slaw sold in North Carolina and South Carolina. The product contains undeclared egg and soy allergens not listed on the label.

    Product
    COLE SLAW Ingredients: cabbage, mayonaise sugar, vinegar, celery seed, salt WT 16 oz WASHINGTON CRAB Carolina seafood
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0932-2023·2023-05-31

    Ultra Tuna Salad Sandwich recall: undeclared egg and wheat allergens

    Ultra Tuna Salad Sandwich sold in Washington contains undeclared egg and wheat allergens. The label fails to declare these common allergens, posing a risk to allergic consumers.

    Product
    Ultra Tuna Salad Sandwich, brand DishD'Lish. The label declares Albacore Tuna with Fresh Herbs, Mayo, Capers, Cucumbers, and pickles on Organic Whole Grain Bread. Served with Sweet Pickle Chips.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0929-2023·2023-05-31

    Washington Crab Crabcakes Recalled Due to Undeclared Allergens

    Washington Crab & Seafood Company recalls crabcakes due to undeclared allergens: egg, wheat, and soy. The product was distributed to North Carolina and South Carolina.

    Product
    CRABCAKE Ingredients: Blue Crabmeat, mayonnaise, onion bread crumbs, egg solids, salt, spices paprika WASHINGTON CRAB Carolina seafood
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0924-2023·2023-05-31

    Lancaster Spinach Recalled for Possible Listeria Contamination

    Lancaster Spinach, 10-ounce packages, is recalled due to possible contamination with Listeria monocytogenes. Products were distributed in Massachusetts, Maryland, Pennsylvania, New York, New Jersey, and Virginia.

    Product
    LANCASTER SPINACH, 10 OZ, UPC:8-13055-01145-3. Packaged in sealed plastic bags, 12 in a case.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Drugs)·D-0690-2023·2023-05-31

    Neonatal TPN Starter Bags Recalled Over Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 418 bags of neonatal TPN starter bags nationwide due to loss of sterility assurance following FDA inspection. The prescription product contains amino acids, dextrose, calcium, and heparin.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0419-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0689-2023·2023-05-31

    Neonatal TPN Starter Bag Recalled Due to Sterility Concerns

    Central Admixture Pharmacy Services recalled 92 bags of Neonatal TPN Starter Bag nationwide after FDA inspection questioned product sterility assurance.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0418-1.
    Category
    Drug
    Distribution
    Distributed nationwide