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.

5776–5800 of 88106

  • ModerateFDA (Drugs)·D-0023-2026·2025-10-22

    Hydromorphone syringes recalled over incorrect or missing lot and expiry

    STAQ Pharma is recalling one lot of Hydromorphone HCL PF 10mg/50 mL injection syringes because of incorrect or missing lot and expiration date information on the label.

    Product
    Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0104-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0025-2026·2025-10-22

    Fentanyl citrate syringes recalled over incorrect or missing lot and expiry

    STAQ Pharma is recalling three lots of FentaNYL Citrate PF 500mcg/50 mL injection syringes because of incorrect or missing lot and expiration date information on the label.

    Product
    FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0102-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0073-2026·2025-10-22

    Apple juice recalled after manufacturing deviation affecting shelf stability

    Tropicana Brands Group is recalling 1,599 cases of Dole Apple Juice in 15.2 fl oz bottles after a manufacturing process deviation that may cause spoilage or microbial contamination.

    Product
    Dole Apple Juice (primary package), 15.2 Fl oz., PET, 12 bottles per case, Refrigerate after opening
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Drugs)·D-0027-2026·2025-10-22

    Sucralfate tablets recalled after bankruptcy left quality program unmonitored

    Amerisource Health Services is recalling 27,868 blister packs of Sucralfate Tablets USP 1 gram because, after a Chapter 11 filing, the firm cannot monitor its quality program.

    Product
    Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0026-2026·2025-10-22

    Everolimus tablets recalled for out of specification impurity in one lot

    Endo USA is recalling 1,041 cartons of Everolimus tablets 5mg after the lot returned an out-of-specification result for impurity IP-C.

    Product
    Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 49884-125-91
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0024-2026·2025-10-22

    Ketamine syringes recalled over incorrect or missing lot and expiry

    STAQ Pharma is recalling one lot of Ketamine Hydrochloride 50mg/5 mL injection syringes because of incorrect or missing lot and expiration date information on the label.

    Product
    Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0029-2026·2025-10-15

    Nitric oxide systems recalled over fault from rapid button presses

    NOxBOX is recalling 1,667 NOxBOXi Nitric Oxide Delivery Systems because a rapid succession of button selections can trigger an unexpected internal fault or system diagnostic error.

    Product
    NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Food)·H-0077-2026·2025-10-15

    Cooked penne pasta recalled over potential Listeria monocytogenes contamination

    Nate's Fine Foods is recalling 1,337 cases of Fresh Creative Foods cooked penne, totaling 32,088 lbs, for potential contamination with Listeria monocytogenes.

    Product
    FRESH CREATIVE FOODS COOKED PENNE PASTA 8 x 3 lb pouches Net Weight: 24 lbs (10.88 kg) PERISHABLE KEEP REFRIGERATED
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·H-0079-2026·2025-10-15

    Cooked rotini pasta recalled over potential Listeria monocytogenes contamination

    Nate's Fine Foods is recalling 383 cases of Taylor Farms cooked rotini, totaling 9,192 lbs, for potential contamination with Listeria monocytogenes.

    Product
    TAYLOR FARMS COOKED ROTINI MAP 8 X 3 lb pouches Net Weight: 24 lbs (10.88 kg) PERISHABLE KEEP REFRIGERATED
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·H-0030-2026·2025-10-15

    Cinnamon Texas toast recalled for undeclared milk from cheese and butter

    Harris Teeter is recalling 83 units of its Cinnamon Texas Toast after finding that cheese and butter were left off the ingredient statement, so milk was not declared.

    Product
    Harris Teeter CINNAMON TEXAS TOAST, NET WT 5.0oz (0.31g), INGREDIENTS BREAD*** CONTAINS WHEAT, UPC 0 72036 95734 4, Harris Teeter Raleigh, NC
    Category
    Food
    Distribution
    8 states
  • CriticalFDA (Food)·H-0076-2026·2025-10-15

    Cooked farfalle pasta recalled again over potential Listeria monocytogenes contamination

    Nate's Fine Foods is recalling 1,442 cases of Fresh Creative Foods cooked farfalle, totaling 34,068 lbs, for potential contamination with Listeria monocytogenes.

    Product
    FRESH CREATIVE FOODS COOKED FARFALLE PASTA 8 x 3 lb pouches Net Weight: 24 lbs (10.88 kg) PERISHABLE KEEP REFRIGERATED
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Devices)·Z-0028-2026·2025-10-15

    Nitric oxide delivery systems recalled over dose fluctuations at low flow

    NOxBOX is recalling 1,667 NOxBOXi Nitric Oxide Delivery Systems because delivered dose may fluctuate when total flow through the device sensor falls below its 0.5 LPM minimum.

    Product
    NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-0069-2026·2025-10-15

    Heart pump controllers recalled over potential operating system cybersecurity vulnerabilities

    Abiomed is recalling 10,153 Automated Impella Controllers over potential cybersecurity vulnerabilities related to the controller's operating system.

    Product
    Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0081-2026·2025-10-15

    Cooked trotolle pasta recalled over potential Listeria monocytogenes contamination

    Nate's Fine Foods is recalling 846 cases of Taylor Farms cooked trotolle, totaling 18,612 lbs, for potential contamination with Listeria monocytogenes.

    Product
    TAYLOR FARMS COOKED TROTOLLE MAP 8 X 2.75 lb pouches Net Weight: 22 lbs (9.97 kg) PERISHABLE KEEP REFRIGERATED
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·H-0011-2026·2025-10-15

    Shell eggs recalled over potential Salmonella contamination across four brands

    Country Eggs is recalling 81,542 dozen shell eggs sold under four brand names in California and Nevada because the product is potentially contaminated with Salmonella.

    Product
    o Nagatoshi Large AA Brown Omega-3 1 dozen cartons o Nijiya Large AA Brown Golden Yolk 1 dozen cartons o Mizuho Large AA Brown Omega-3 Cage 1 dozen cartons o Country Eggs Large AA Brown Sunshine Yolk 15 dozen bulk loose
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·H-0080-2026·2025-10-15

    Cooked farfalle pasta recalled over potential Listeria monocytogenes contamination

    Nate's Fine Foods is recalling 261 cases of Taylor Farms cooked farfalle, totaling 6,264 lbs, for potential contamination with Listeria monocytogenes.

    Product
    TAYLOR FARMS COOKED FARFALLE MAP 8 X 3 lb pouches Net Weight: 24 lbs (10.88 kg) PERISHABLE KEEP REFRIGERATED
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Devices)·Z-0035-2026·2025-10-15

    Infusion pump sets recalled over flow rate and occlusion alarm accuracy

    CareFusion is recalling BD Alaris Pump Infusion Sets because the pump module used with them may perform outside established ranges for flow rate, bolus accuracy and occlusion alarm timing.

    Product
    BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site 10015414, 180 Micron Filter 2447-0007, Ball Valve SmartSite Port (Burette) 2 SmartSites Y-Sites 24201-0007, 2 SmartSite Y-sites…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0075-2026·2025-10-15

    Cooked fettuccine cases recalled over potential Listeria monocytogenes contamination

    Nate's Fine Foods is recalling 1,357 cases of MAP cooked fettuccine pasta, totaling 40,710 lbs, for potential contamination with Listeria monocytogenes.

    Product
    MAP COOKED FETTUCCINE PASTA 6 x 5 lbs pouches Net Weight: 30 lbs (13.60kg) PERISHABLE KEEP REFRIGERATED
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·H-0029-2026·2025-10-15

    Asiago Texas toast recalled for undeclared milk from cheese and butter

    Harris Teeter is recalling 295 units of its Asiago Texas Toast after finding that cheese and butter were left off the ingredient statement, so milk was not declared.

    Product
    Harris Teeter ASIAGO TEXAS TOAST, NET WT 5.0OZ (0.3lb), INGREDIENTS BREAD***CONTAINS WHEAT, UPC 0 72036 95364 3, Harris Teeter Raleigh, NC
    Category
    Food
    Distribution
    8 states