The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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20251–20275 of 114364

  • 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-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 (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 (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-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 (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-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 (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
  • 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 (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
    1 state
  • 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 (Food)·F-0295-2024·2023-10-25

    Safeway Recalls Diced Organic Butternut Squash for E. Coli O45

    Safeway Fresh Foods is recalling 32-oz. Diced Organic Butternut Squash distributed exclusively to Costco in Washington DC, Maryland, Pennsylvania, and Virginia due to potential E. coli O45 contamination.

    Product
    Sunnyside Farms, diced Organic Butternut Squash , 32-oz. , plastic tray, 6 trays per case, Perishable Keep Refrigerated .
    Category
    Food
    Distribution
    3 states
  • 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-0122-2024·2023-10-25

    Functional MRI Software Bug May Cause DICOM Export Data Mismatch

    A software bug in Functional MR V1.0 can cause file contents and descriptions to not match when exporting multiple regions of interest in DICOM format, potentially leading to misinterpretation of clinical imaging data.

    Product
    Functional MR V1.0
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-0058-2024·2023-10-25

    FDA Recalls Compounded Moxifloxacin Syringes for Lack of Sterility Assurance

    Pine Pharmaceuticals recalls 2,176 syringes of compounded moxifloxacin nationwide due to inadequate sterility assurance. The product was distributed to healthcare providers and patients.

    Product
    Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 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 (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