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.

16251–16275 of 88183

  • HighFDA (Drugs)·D-0054-2024·2023-10-25

    Calcium Gluconate Inhalation Solution Recalled Due to Sterility Concerns

    Pine Pharmaceuticals is recalling Calcium Gluconate 2.5% inhalation solution due to lack of sterility assurance. Patients should stop using affected syringes and contact their healthcare provider.

    Product
    Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0114-2024·2023-10-25

    HydroPICC Catheter Kit Recall: Missing Critical Use-Restriction Warnings

    Access Vascular is recalling HydroPICC Dual Lumen Catheter kits with incorrect instruction documents that omit critical warnings about adult-only use and vessel sizing. No adverse events have been reported.

    Product
    HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0059-2024·2023-10-25

    Compounded Lidocaine-Phenylephrine Injectable Recalled Due to Sterility Assurance Issues

    Pine Pharmaceuticals is recalling 9,673 vials of compounded lidocaine-phenylephrine injectable due to lack of assurance of sterility. Affected lots were distributed nationwide.

    Product
    Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0051-2024·2023-10-25

    Vancomycin Intraocular Injection Recalled Due to Sterility Assurance Failure

    Pine Pharmaceuticals is recalling 26 vials of Vancomycin 1 MG/0.1 ML intraocular injection (Lot #69985) due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0055-2024·2023-10-25

    FDA Recalls Compounded Ophthalmic Solution Due to Sterility Concerns

    Pine Pharmaceuticals recalls Tropi-Phen ophthalmic solution due to lack of sterility assurance. The 15 mL droppers were distributed nationwide and customers should not use affected lots.

    Product
    Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0294-2024·2023-10-25

    Mint chip ice cream recalled for undeclared wheat, soy, and coconut

    Katie's Korner Inc. is recalling 35 units of 3-gallon mint chip ice cream due to undeclared wheat, soy, and coconut. Consumers with allergies to these ingredients should not consume the product.

    Product
    3 Gallon, plastic container of mint chip flavored ice cream
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0061-2024·2023-10-25

    Calcium Chloride IV Solution Recalled Due to Sterility Assurance Concerns

    Pine Pharmaceuticals recalls Calcium Chloride IV Solution for Intravenous Injection, 20 mg/mL (lot 70101), due to lack of assurance of sterility. Approximately 130 units were distributed nationwide.

    Product
    Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0286-2024·2023-10-25

    Sweet Potatoes Recalled Due to Processing Equipment Failure

    Moody Dunbar Inc recalls HEB and Sysco brand sweet potatoes because a sterilization monitoring chart malfunctioned during production, preventing verification of adequate heat treatment.

    Product
    Sweet Potatoes sold under the brand names: HEB CUT SWEET POTATOES IN LIGHT SYRUP NET WT. 29 OZ (1 LB 13 OZ) 822g MADE WITH PRIDE AND CARE FOR HEB, SAN ANTONIO, TEXAS 78204 UPC 0 41220 45933 9 & SYSCO Classic Cut Sweet Potatoes NET WT/PESO NETO 108 OZ (6 LB 12 OZ) 3.06 kg…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0113-2024·2023-10-25

    Stryker Tornier Reversed Glenoid Baseplate Recalled for Manufacturing Defect

    One lot of Stryker Tornier Perform Reversed Glenoid Baseplate components was manufactured with incorrect 6mm spacers instead of 3mm, preventing proper assembly. The defect affects 30 units distributed across ten US states.

    Product
    stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0112-2024·2023-10-25

    Monoject tuberculin syringes incompatible with certain IV connectors

    Cardinal Health is recalling Monoject tuberculin syringes because the conical tip is incompatible with certain needleless IV connectors.

    Product
    Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0056-2024·2023-10-25

    Intraocular Moxifloxacin Injection Recalled Due to Sterility Assurance Issues

    Pine Pharmaceuticals is recalling 2,484 syringes of Moxifloxacin intraocular injection nationwide due to lack of sterility assurance in the compounded product.

    Product
    Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL (150 mcg/0.1mL) Syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0296-2024·2023-10-25

    Kraft Singles American Cheese Recalled for Plastic Film Fragment Risk

    Heinz is recalling Kraft Singles American Cheese because thin plastic film fragments may remain on cheese slices after unwrapping. Affected product was distributed nationwide and in Puerto Rico.

    Product
    Kraft Singles American Pasteurized Prepared Cheese product, 24 individually wrapped slices in flexible film per pack, net wt. per pack 16oz, keep refrigerated. Single pack is sold at retail. Case UPC 0 00 2100007180 7; Single Pack UPC 0 2100061526 1: Each case contains 27…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0044-2024·2023-10-25

    Sun Pharmaceutical Bupropion Extended-Release Tablets Recalled for Failed Dissolution

    Sun Pharmaceutical is recalling Bupropion Hydrochloride Extended-Release Tablets (150 mg), lot HAD0360A, due to failed dissolution specifications. The 144 bottles were distributed nationwide and may not dissolve at the intended rate.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0045-2024·2023-10-25

    Over-the-counter drugs from Family Dollar recalled for improper storage

    Dollar Tree Distribution recalled approximately 4.3 million over-the-counter drug products sold by Family Dollar stores nationwide after discovering they were stored outside of labeled temperature requirements.

    Product
    Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0118-2024·2023-10-25

    Medline ReNewal Ligasure Maryland Jaw Sealer devices recalled for incomplete packaging seals

    Medline is recalling 58 units of ReNewal Ligasure Maryland Jaw Sealer electrosurgical instruments due to incomplete seals on packaging trays that may allow contamination during reprocessing.

    Product
    MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible with FT10 Generator, REF LF1944CR. electrosurgical instrument
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0117-2024·2023-10-25

    Electrosurgical Devices Recalled for Incomplete Packaging Tray Seal

    Medline is recalling 11 reprocessed Covidien LigaSure and Ethicon Harmonic electrosurgical devices due to incomplete seals on their packaging trays.

    Product
    MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF1844CR. electrosurgical instrument
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0043-2024·2023-10-25

    Ophthalmic Solution Recalled Due to Subpotent Ketorolac Levels

    MYDRIATIC-4 ophthalmic solution is being recalled because ketorolac levels fell below the required 90-110% specification. The product was distributed to physician offices nationwide.

    Product
    MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0121-2024·2023-10-25

    SenSight Connector Plug Recalled for Use By Date Label Discrepancy

    Medtronic Neuromodulation is recalling 65 units of the SenSight Connector Plug, Model B31061, due to a discrepancy in the Use By Date printed on the device label. The company is requesting return of affected units.

    Product
    SenSight Connector Plug, Model Number B31061.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0119-2024·2023-10-25

    MEDLINE Electrosurgical Instruments Recalled for Incomplete Packaging Seals

    MEDLINE INDUSTRIES is recalling ReNewal Ligasure Sealer/Divider electrosurgical instruments due to incomplete seals on packaging trays. The recall affects 268 units distributed in the United States.

    Product
    MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF4418CR. electrosurgical instrument
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Food)·F-0011-2024·2023-10-18

    Ginger Snap Milk Chocolate recalled for undeclared peanut allergen

    Dick Taylor Inc is recalling Ginger Snap Milk Chocolate due to undeclared peanut allergen. People with peanut allergies may experience serious allergic reaction if they consume this product.

    Product
    Ginger Snap Milk Chocolate, 2 oz wrapped
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0287-2024·2023-10-18

    Quaker Pancakes with Whole Grain Oats Recalled for Undeclared Soy Allergen

    Comercializadora Pepsico Mexico recalls Quaker Pancakes with Whole Grain Oats due to undeclared soy allergen. The product contains soy not listed on the label, creating a health risk for consumers with soy allergies.

    Product
    QUAKER PANCAKES WITH WHOLE GRAIN OATS, NET WT 15.97OZ (1LB)
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-0028-2024·2023-10-18

    FDA Recalls Fresenius 2008T Hemodialysis Systems Due to PCBA Leaching

    Fresenius Medical Care is recalling 703 units of the Fresenius 2008T Hemodialysis System nationwide due to potential PCBA (printed circuit board assembly) leaching from machine tubing.

    Product
    2008T Hemodialysis SYS, with CDX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0034-2024·2023-10-18

    Hemodialysis machines recalled due to potential circuit board material leaching

    Fresenius Medical Care is recalling 733 units of 2008T hemodialysis systems nationwide due to potential leaching of printed circuit board assembly material from tubing. No illnesses or injuries have been reported.

    Product
    2008T HD SYS. W/O CDX BLUESTAR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0007-2024·2023-10-18

    LuLu Chinese Express Korean Noodles Recalled for Undeclared Egg Allergen

    LuLu Chinese Express Korean Noodles (Japchae) with Vegetables are being recalled due to undeclared egg allergen. The 54 containers distributed in Missouri may pose a health risk to consumers with egg allergies.

    Product
    LuLu Chinese Express Korean Noodles (Japchae) w/ Vegetables. Net Wt 16oz.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0035-2024·2023-10-18

    Hemodialysis Systems Recalled for Potential PCBA Tubing Leaching

    Fresenius Medical Care is recalling 733 hemodialysis machines nationwide due to potential leaching of circuit board material from tubing. Affected equipment may contaminate blood or dialysate during treatment.

    Product
    2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
    Category
    Medical Device
    Distribution
    Distributed nationwide