The Recall Desk

Hazard

Fungal Contamination recalls

60 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
60
Critical
7
Severe
19
Most recent
2026-07-01

Of the 60 fungal contamination recalls we have scored against our rubric, 7 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 19 (32%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all fungal contamination recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–25 of 60

  • SevereFDA (Drugs)·D-0625-2026·2026-07-01

    ChloraPrep One-Step Antiseptic Solution Recall Due to Sterility Concerns

    CareFusion is recalling 178,000 ChloraPrep One-Step antiseptic applicators (Lot #4073005) nationwide due to potential non-sterility from fungal contamination and seal breaches from paper lidding wrinkles.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0624-2026·2026-07-01

    ChloraPrep One-Step Topical Antiseptic Recalled for Non-Sterility

    CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) topical applicators due to non-sterility caused by the presence of Aspergillus penicillioides fungal contamination.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1093-2026·2026-01-21

    Cell wash solution recalled over fungal contamination of an affected lot

    Hologic is recalling 3,728 units of ThinPrep CytoLyt Solution over fungal contamination of the affected lot with Parengyodontium album.

    Product
    ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0504-2025·2025-07-09

    Zicam cold remedy nasal swabs recalled over fungal contamination

    Zicam Cold Remedy Medicated Nasal Swabs are being recalled because of fungal contamination of the swabs. All lots are affected, covering 3,374,918 cartons.

    Product
    ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216 30120 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0505-2025·2025-07-09

    Zicam Nasal AllClear swabs recalled over fungal contamination of swabs

    Zicam Nasal AllClear swabs are being recalled because of fungal contamination of the nasal swabs. All lots are affected, covering 13,632 cartons.

    Product
    ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216 30165 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0506-2025·2025-07-09

    Orajel Baby teething swabs recalled over fungal contamination of swabs

    Orajel Baby Cooling Swabs for Teething are being recalled because of fungal contamination of the infant oral swabs. All lots are affected, covering 695,880 cartons.

    Product
    Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ (2.6 mL) TOTAL, 12 Single-Use Swabs per carton, Manufactured for Church & Dwight Co. Inc. Ewing. NJ 08328 USA. UPC CODE 3 10310 40000 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1483-2024·2024-04-17

    KWIK-STIK Quality Control Kit Recalled for Fungal Contamination

    Microbiologics Inc recalls KWIK-STIK quality control kits contaminated with Aspergillus brasiliensis fungus. Users may observe unexpected fungal growth when using affected control material.

    Product
    KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0308-2024·2023-11-22

    Laboratory Culture Disks Recalled for Aspergillus Flavus Contamination

    Microbiologics Inc is recalling LYFO-DISK P. venetum laboratory culture disks (lot 794-142) found contaminated with Aspergillus flavus during complaint investigation. The product was distributed worldwide.

    Product
    LYFO-DISK, P. venetum, Catalog number 0794L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0043-2022·2021-11-03

    Testosterone Cypionate Injectable Recalled for Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling testosterone cypionate 200mg/ml in sesame oil due to FDA concerns about lack of sterility assurance. The product was distributed to approximately 494 patients across seven states.

    Product
    TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • CriticalFDA (Devices)·Z-1786-2021·2021-06-16

    Medical Convenience Kits Recalled Due to Mold Contamination Risk

    Avid Medical is recalling 160 fistula care kits due to potential contamination from Aspergillus penicillioides fungal growth in a component applicator. The contamination could breach the kit's package integrity and affect other sterile components.

    Product
    FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1785-2021·2021-06-16

    Avid Medical Fistula On-Off Kit Recalled for Potential Fungal Contamination

    Avid Medical is recalling 720 Fistula On-Off Kits due to potential fungal contamination that may compromise package integrity. The BD ChloraPrep applicator component may develop Aspergillus penicillioides, which could contaminate other kit components.

    Product
    FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1623-2021·2021-05-26

    Bioseal Chest Tube Insertion Tray Recalled for Mold Contamination

    Bioseal Corporation is recalling 140 units of Chest Tube Insertion Trays because the included ChloraPrep applicator may allow Aspergillus penicillioides growth, potentially breaching package integrity.

    Product
    Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1624-2021·2021-05-26

    Bioseal Central Line Dressing Kits Recalled for Potential Mold Growth

    Bioseal Corporation is recalling 580 Central Line Dressing Kits because the included ChloraPrep applicator may allow Aspergillus penicillioides growth, potentially breaching package integrity.

    Product
    Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096
    Category
    Medical Device
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-0344-2021·2021-05-05

    ChloraPrep One-Step Recalled for Fungal Contamination and Package Breach

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators because fungal growth breached package integrity. The product is a sterile skin antiseptic.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0343-2021·2021-05-05

    FDA Recalls Chloraprep One-Step Antiseptic Due to Fungal Contamination

    CareFusion 213, LLC is recalling Chloraprep One-Step antiseptic applicators because fungal growth breached package integrity. The product is distributed nationwide and internationally.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0348-2021·2021-05-05

    ChloraPrep One-Step Recalled for Potential Fungal Growth and Package Breach

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators due to a lack of assurance of sterility. The product may allow fungal growth at labeled storage conditions, potentially breaching package integrity.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0347-2021·2021-05-05

    ChloraPrep One-Step Recalled for Potential Fungal Growth and Sterility Breach

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators due to potential fungal growth that may breach package integrity and compromise sterility.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0265-2021·2021-03-03

    FDA Recalls Chloraprep One-Step Due to Potential Fungal Growth

    CareFusion 213, LLC is recalling Chloraprep One-Step applicators distributed in Puerto Rico and Oman due to potential fungal growth in hot, humid conditions.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0268-2021·2021-03-03

    FDA Recalls Chloraprep One-Step Antiseptic Due to Non-Sterility Risk

    CareFusion 213, LLC is recalling 400 cartons of Chloraprep One-Step antiseptic applicators distributed in Puerto Rico and Oman due to potential fungal growth and package integrity breaches.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-1509-2020·2020-08-26

    FDA Recalls Chloraprep One-Step Applicators Due to Non-Sterility

    CareFusion 213, LLC is recalling 12,500 units of Chloraprep One-Step applicators because they are not sterile and contain Aspergillus Penicilloides.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-1511-2020·2020-08-26

    CareFusion Chlorhexidine Applicators Recalled for Non-Sterility

    CareFusion 213, LLC is recalling ChlroraPrep One-Step applicators due to the presence of Aspergillus Penicilloides.

    Product
    ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-01
    Category
    Medical Device
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-1510-2020·2020-08-26

    CareFusion Recalls ChloraPrep Applicators Due to Non-Sterility

    CareFusion is recalling ChloraPrep With Tint applicators because they are not sterile and contain Aspergillus Penicilloides.

    Product
    ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-11
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0586-2020·2019-12-18

    Fentanyl Citrate Recalled by Anazao Health Due to Fungal Contamination

    Anazao Health is recalling Fentanyl Citrate products because environmental sampling detected Talaromyces rotundus, a fungus, indicating a lack of processing controls.

    Product
    Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0598-2020·2019-12-18

    Anazao Health Recalls Compounded Clonidine Syringes Due to Fungal Contamination

    Anazao Health is recalling compounded Clonidine, Prialt, and Bupivacaine syringes because environmental sampling detected Talaromyces rotundus, a fungus.

    Product
    Clonidine HCL PF 750 mcg/mL/Prialt PF (vial) 55 mcg/mL/Bupivacaine HCL PF 24 mg/mL *Compounded 20 mL Syringe (Standard) AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634 (800) 995-4363
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0587-2020·2019-12-18

    Anazao Health Recalls Fentanyl and Morphine Compounded Drugs Due to Fungal Contamination

    Anazao Health is recalling compounded fentanyl and morphine drugs after environmental sampling detected Talaromyces rotundus fungi.

    Product
    Fentanyl Citrate and Bupivacaine HCl and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide