The Recall Desk

Hazard

Sterility Failure recalls

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

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility failure 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 462

  • SevereFDA (Drugs)·D-0517-2026·2026-05-13

    PurPrep Povidone-Iodine and Isopropyl Alcohol Solution Recalled for Sterility Assurance

    CareFusion 213, LLC is recalling PurPrep sterile topical solution due to lack of assurance of sterility and potential product contamination. The affected product is a povidone-iodine and isopropyl alcohol solution distributed nationwide.

    Product
    PURPREP — PURPREP (POVIDONE IODINE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0513-2026·2026-05-13

    DELFLEX Peritoneal Dialysis Solution Recall Due to Potential Sterility Issues

    Fresenius Medical Care is recalling DELFLEX Dextrose Peritoneal Dialysis Solution bags due to potential leaks from bag perforations that could compromise sterility. Affected patients should contact their healthcare provider immediately.

    Product
    DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0489-2026·2026-04-29

    Harrow Eye FRESHKOTE Lubricant Eyedrops Sterile 10mL Recall

    Harrow Eye LLC is recalling FRESHKOTE Lubricant Eyedrops because the manufacturer cannot guarantee the product remains sterile. Affected lots are 1X68 and 1X69, with an expiration date of 05/31/2027.

    Product
    FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0471-2026·2026-04-22

    Compounded Semaglutide Injectable Recalled Due to Sterility Failure

    Payless Compounders is recalling a compounded semaglutide injectable due to lack of sterility assurance. The recall affects 91 vials distributed in Oregon.

    Product
    Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beaverton, OR
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0439-2026·2026-04-15

    Norepinephrine Injectable Recalled Due to Sterility and Equipment Safety Concerns

    Fagron Compounding Services is recalling 5,140 bags of norepinephrine injectable nationwide due to lack of sterility assurance and a potentially detachable component in the administration port. The affected lots expire between April and July 2026.

    Product
    norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5027-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0431-2026·2026-04-15

    Sodium Chloride Injectable Solution Recalled for Sterility Assurance Failure

    Fresenius Kabi USA, LLC is recalling specific batches of 0.9% Sodium Chloride Injection due to lack of assurance of sterility. Patients who have this product should contact their healthcare provider.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0434-2026·2026-04-15

    Intravenous Sodium Chloride Injection Recalled Due to Sterility Assurance Failure

    Fresenius Kabi USA is recalling a batch of 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The product was distributed nationwide, in Alaska, and Puerto Rico.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0428-2026·2026-04-15

    Sodium Chloride Injection Recalled for Lack of Sterility Assurance

    Fresenius Kabi recalled specific batches of 0.9% sodium chloride injection because sterility cannot be assured. The affected batches were distributed throughout the United States, Alaska, and Puerto Rico.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0442-2026·2026-04-15

    Injectable vancomycin drug recalled for sterility assurance and port defects

    Fagron Compounding Services is recalling Vancomycin HCL injectable solutions due to lack of sterility assurance and risk that a blue break-off part could detach from the administration port.

    Product
    Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5082-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0443-2026·2026-04-15

    Artificial Tears eye drops recalled due to lack of sterility assurance

    Artificial Tears glycerin eye drops made by Preferred Pharmaceuticals are being recalled due to lack of sterility assurance. The 0.5 oz bottles were distributed nationwide.

    Product
    ARTIFICIAL TEARS — ARTIFICIAL TEARS (GLYCERIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0416-2026·2026-04-08

    Artificial eye drops recalled for lack of sterility assurance

    K.C. Pharmaceuticals recalls Leader Artificial Tears and related generic brands nationwide due to inability to assure product sterility. Approximately 589,848 bottles across multiple brands and retailers are affected.

    Product
    LEADER ARTIFICIAL TEARS 15 ML — LEADER ARTIFICIAL TEARS 15 ML (POLYVINYL ALCOHOL, POVIDONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0402-2026·2026-04-01

    FDA Recalls CUROSURF Injectable Drug Over Sterility Assurance Concerns

    Chiesi USA, Inc. is recalling 7,235 vials of CUROSURF (poractant alfa) nationwide due to lack of assurance of sterility. The affected intratracheal injection is used in neonatal care.

    Product
    CUROSURF — CUROSURF (PORACTANT ALFA)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0393-2026·2026-03-11

    Semaglutide Injectable Vial Recalled Due to Lack of Sterility Assurance

    Semaglutide injectable vials (lot 240903) are being recalled due to lack of sterility assurance. The product was distributed in Ohio with expiration 9/30/2026.

    Product
    Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-06
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1434-2026·2026-03-04

    Medline Nail Kit Recalled for Sterile Saline Wound Wash Sterility Failure

    Medline has recalled certain Nail Kits because the sterile saline wound wash component may not meet required sterility standards. The affected kits were distributed nationwide and internationally.

    Product
    Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1435-2026·2026-03-04

    Meijer Saline Wound Wash Recalled Due to Sterility Assurance Level Failure

    Medline Industries is recalling Meijer STERILE saline wound wash because the manufacturer may not have met required sterility standards. The recalled product was distributed nationwide in the US and internationally.

    Product
    Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MJSALINE7
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0349-2026·2026-03-04

    Eye Lubricant Recalled for Lack of Sterility Assurance Nationwide

    Vista Gonio Eye Lubricant is recalled nationwide due to lack of sterility assurance during manufacturing. The product was not made under proper conditions required for eye medications.

    Product
    VISTA GONIO EYE LUBRICANT — VISTA GONIO EYE LUBRICANT (HYPROMELLOSE OPHTHALMIC SOLUTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0346-2026·2026-03-04

    Vista Tears Eye Drops Recalled for Lack of Sterile Manufacturing

    Vista Tears polyethylene glycol 400 and propylene glycol 0.3% eye drops are recalled nationwide due to failure to assure sterile manufacturing conditions. Consumers should stop using the product and contact their healthcare provider if they have experienced eye problems.

    Product
    Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0352-2026·2026-03-04

    BioGlo Fluorescein Sodium Ophthalmic Strips Recalled for Sterility Concerns

    The FDA has recalled 184,320 containers of BioGlo Fluorescein Sodium Ophthalmic Strips nationwide due to lack of sterility assurance resulting from manufacturing non-compliance. Consumers should stop using the product and consult a healthcare provider.

    Product
    BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:[email protected], Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1431-2026·2026-03-04

    Medline Sterile Saline Wound Wash Recalled for Potential Sterility Issues

    Medline is recalling sterile saline wound wash products due to potential failure to meet required sterility assurance levels. The products may not be guaranteed sterile for safe wound care.

    Product
    Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MDSALINE7
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1432-2026·2026-03-04

    Medline Nail Kit Recalled for Sterile Wound Wash Sterility Deficiency

    Medline is recalling 1,640 Nail Kits containing sterile saline wound wash because the manufacturer may not have met minimum sterility assurance levels. The affected kits were distributed nationwide and internationally.

    Product
    Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0351-2026·2026-03-04

    Bio Glo Fluorescein Sodium Ophthalmic Strips Recalled Due to Sterility Failure

    Bio Glo Fluorescein Sodium Ophthalmic Strips are being recalled due to lack of assured sterility and failure to comply with good manufacturing practices.

    Product
    Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:[email protected], Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ven
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0347-2026·2026-03-04

    FDA Recalls Vista Hypromellose Eye Drops Due to Sterility Manufacturing Defects

    Vista Hypromellose eye drops have been recalled nationwide due to sterility assurance failures and noncompliance with manufacturing standards. Approximately 17,280 cartons are affected.

    Product
    VISTA HYPROMELLOSE DRY EYE RELIEF — VISTA HYPROMELLOSE DRY EYE RELIEF (HYPROMELLOSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1415-2026·2026-02-25

    Medline Surgical Convenience Kits Recalled for Sterilization Equipment Calibration Issues

    Medline is recalling 12,418 surgical convenience kits due to calibration issues with sterilization and packaging equipment that may compromise sterility assurance. No illnesses have been reported.

    Product
    Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 3) NHP ROBOTIC GYNE CDS, Model Number: CDS984243G; 4) ROBOTIC-LF, Model Number: CDS984543D; 5) ROBOTIC-LF, Model Number: CDS984543F; 6) ROBOTIC-L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1400-2026·2026-02-25

    Medline Convenience Kits Recalled for Sterilization Equipment Calibration Issues

    Medline Industries is recalling 1,496 Convenience Kits due to calibration issues with sterilization and packaging equipment. The calibration defects could compromise the sterility assurance of these surgical instrument kits.

    Product
    Medline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 2) TOTE SEN OSC HAND REPAIR, Model Number: DYKM1776; 3) TOTE MOMENI SB CAPSULOTOMY REC, Model Number: DYKM1765A; 4) TOTE YAO OSC HAND REPAIR, Model Number: DYKM1796A; 5) TOTE SB NGUYEN CA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1412-2026·2026-02-25

    Medline Convenience Kits Recalled for Potential Sterility Issues

    Medline Industries is recalling certain Chest/Breast-LF Convenience Kits due to equipment calibration issues that could compromise sterility assurance during sterilization and packaging. The affected kits were distributed nationwide.

    Product
    Medline Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950
    Category
    Medical Device
    Distribution
    Distributed nationwide