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.

14501–14525 of 27263

  • 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 DISTRIBU
    Category
    Food
    Distribution
    0 states
  • 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-0057-2024·2023-10-25

    Cefuroxime Injectable Syringes Recalled for Lack of Sterility Assurance

    Pine Pharmaceuticals is recalling 4,972 syringes of Cefuroxime injectable medication due to lack of assurance of sterility. The compounded antibiotic was distributed nationwide.

    Product
    Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0065-2024·2023-10-25

    Foscarnet Sodium Injectable Recalled Due to Lack of Sterility Assurance

    Pine Pharmaceuticals is recalling Foscarnet Sodium 2.4mg/0.1 mL injectable syringes nationwide due to lack of assurance of sterility. No illnesses or injuries have been reported.

    Product
    Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0063-2024·2023-10-25

    FDA Recalls Tropi-Phen Ophthalmic Solution Due to Sterility Assurance Failure

    Pine Pharmaceuticals has recalled 662 dropper units of Tropi-Phen ophthalmic solution due to lack of sterility assurance. The affected lots were distributed nationwide.

    Product
    Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0048-2024·2023-10-25

    Doxil Chemotherapy Drug Recalled for Improper Storage Temperature During Shipment

    Baxter Healthcare is recalling 472 vials of Doxil chemotherapy medication due to exposure to temperatures exceeding labeled storage conditions during transportation. Affected vials were distributed nationwide.

    Product
    DOXIL — DOXIL (DOXORUBICIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0053-2024·2023-10-25

    Calcium Gluconate Ophthalmic Irrigation Solution Recall Due to Sterility Concerns

    Pine Pharmaceuticals is recalling Calcium Gluconate Ophthalmic Irrigation Solution 1% (Lot #69802) due to lack of sterility assurance. The 128 bags distributed nationwide may pose infection risk if used.

    Product
    Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0052-2024·2023-10-25

    Endophth Kit Recalled Due to Lack of Sterility Assurance

    Pine Pharmaceuticals recalled an Endophth Kit (Vancomycin/Ceftazidime injectable) distributed nationwide due to lack of assurance of sterility. The recall affects 201 kits from lot 69986 (expires 11/15/2023).

    Product
    Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0120-2024·2023-10-25

    Surgical Instrument Shears Recalled Due to Incomplete Packaging Seal

    MEDLINE ReNewal Harmonic ACE+7 surgical shears may have incomplete seals on packaging trays. Approximately 18 units were distributed in the United States. Affected products should not be used.

    Product
    MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical instrument.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0060-2024·2023-10-25

    TPC Drops Ophthalmic Solution Recalled for Lack of Sterility Assurance

    Pine Pharmaceuticals is recalling TPC Drops ophthalmic solution due to lack of assurance of sterility. The recall affects 1693 droppers distributed nationwide.

    Product
    TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0062-2024·2023-10-25

    Lidocaine eye drops recalled due to lack of sterility assurance

    Pine Pharmaceuticals is recalling Lidocaine HCl 4% ophthalmic solution due to lack of sterility assurance. The affected product was distributed nationwide in 1,598 single-use droppers.

    Product
    Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0064-2024·2023-10-25

    Compounded Intranasal Lidocaine-Oxymetazoline Solution Recalled Due to Sterility Assurance

    Pine Pharmaceuticals is recalling 860 syringes of intranasal lidocaine-oxymetazoline solution distributed nationwide due to lack of sterility assurance. Lot 67808 expired 10/23/2023.

    Product
    Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, 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 packs
    Category
    Food
    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-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 (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-0050-2024·2023-10-25

    Compounded Bevacizumab Injectable Syringes Recalled for Sterility Assurance

    Pine Pharmaceuticals is recalling approximately 2,862 syringes of compounded Bevacizumab 1.25 MG/0.05 ML Solution for Injection due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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 (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 (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 (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 (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 (Devices)·Z-0115-2024·2023-10-25

    HydroPICC Catheter Kit Recalled for Missing Safety Warnings

    Access Vascular recalls HydroPICC 5Fr Dual Lumen Maximal Barrier Kits due to incorrect Instructions For Use missing warnings about adult-use only and vessel sizing risks. No adverse events reported.

    Product
    HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0116-2024·2023-10-25

    DeRoyal Head and Neck Surgical Kits Recalled for Damaged Syringe Luer Tip

    DeRoyal Industries is recalling 32 surgical procedure kits containing syringes with potentially damaged luer tips that could compromise the sterile packaging barrier. The kits were distributed in Pennsylvania.

    Product
    DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0125-2024·2023-10-25

    Wrist and Thumb Orthosis Recalled for Undeclared Latex

    North Coast Medical Inc is recalling the Gladiator Wrist & Thumb Orthosis because the thumb strap may contain latex that is not declared on the product label. People with latex allergies are at risk.

    Product
    Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right), NC86654 (Large/Left), NC86655 (Large/Right), NC86656 (X-Large/Left), and NC86657 (X-Large/Right)
    Category
    Medical Device
    Distribution
    3 states