The Recall Desk

Hazard

Non Sterility recalls

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

What the numbers show

Total
145
Critical
85
Severe
55
Most recent
2026-07-01

Of the 145 non sterility recalls we have scored against our rubric, 85 (59%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 55 (38%) 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 non sterility 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 145

  • 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
  • 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 (Devices)·Z-1931-2026·2026-04-29

    LSL Healthcare Infant Central Line Dressing Change Kit Recalled

    LSL Healthcare is recalling its Infant Central Line Dressing Change Kit (Model 2925H) distributed nationwide because it contains Webcol Large Alcohol Prep Pads that were recalled for non-sterility.

    Product
    LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1932-2026·2026-04-29

    IV Start Kit with Non-Sterile Alcohol Prep Pads Recalled

    LSL Healthcare is recalling IV Start Kits containing Webcol Large Alcohol Prep Pads due to non-sterility concerns. The affected kits were distributed nationwide in Maryland, Illinois, and Minnesota.

    Product
    LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1928-2026·2026-04-29

    Central Line Dressing Kit containing non-sterile alcohol prep pads recalled

    LSL Healthcare's Central Line Dressing Kit (Model 2717H) is being recalled because it contains Webcol Large Alcohol Prep Pads that were found to be non-sterile. The kits were distributed nationwide in Maryland, Illinois, and Minnesota.

    Product
    LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1930-2026·2026-04-29

    Foley Urine Collection Kit recalled for non-sterile alcohol prep pads

    LSL Healthcare is recalling its Foley Urine Collection Kit (Model 1555) because it contains Webcol Large Alcohol Prep Pads that are non-sterile. The kits were distributed nationwide in Maryland, Illinois, and Minnesota.

    Product
    LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1929-2026·2026-04-29

    LSL Healthcare Central Line Dressing Change Kit Recalled for Non-Sterility

    LSL Healthcare is recalling its Standard Central Line Dressing Change Kit (Model 2717J) because the included Webcol Large Alcohol Prep Pads were found to be non-sterile.

    Product
    LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1933-2026·2026-04-29

    LSL Healthcare Wound Closure Tray Model 7554 Recalled for Non-Sterility

    LSL Healthcare is recalling its Wound Closure Tray (Model 7554) distributed nationwide to Maryland, Illinois, and Minnesota because the kits contained non-sterile Webcol Large Alcohol Prep Pads.

    Product
    LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0528-2026·2026-03-25

    Webcol alcohol prep pads recalled as Class I for microbial contamination

    Cardinal Health is recalling Webcol Alcohol Prep pads because of non-sterility, with microbial contamination identified as Paenibacillus phoenicis. The FDA has classified this recall as Class I.

    Product
    Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Waukegan, IL 60085.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0259-2025·2025-03-19

    ChloraPrep One-Step Topical Drug Recalled for Fungal Contamination

    CareFusion 213, LLC is recalling ChloraPrep One-Step, a preoperative skin preparation drug, due to non-sterility from a package lidding breach allowing fungal contamination. The recall affects 205,440 applicators distributed nationwide and in Canada.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0200-2025·2025-01-22

    Systane Lubricant Eye Drops Recalled for Non-Sterility Risk

    Alcon Research is voluntarily recalling Systane Lubricant Eye Drops, Ultra PF, due to non-sterility concerns. The recall affects 55,960 boxes distributed nationwide.

    Product
    Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1091-2024·2024-03-06

    Medline Tracheostomy Care Kits Recalled for Non-Sterile Component Solutions

    Medline Industries is recalling care and cleaning kits for tracheostomy and stomas due to component solutions that may not be sterile. The affected kits contain Nurse Assist-manufactured saline and irrigation solutions distributed in the U.S., Puerto Rico, Canada, UAE, and Panama.

    Product
    MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH CLEANING KIT, REF DYNDJ1129; b) TRACH CARE TRAY, REF DYNDJ1057A; c) TRACHEOSTOMY CARE KIT, REF DYNDA1893A; d) TRACH CARE TRAY, REF DYNDA1482
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0293-2024·2024-02-14

    FDA recalls Rugby brand lubricating eye drops nationwide for non-sterility

    Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops are being recalled nationwide due to non-sterility. The recall affects all lots of the 0.5 FL OZ bottles distributed.

    Product
    Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1325-94
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0308-2024·2024-02-14

    FDA Class I Drug Recall: Non-Sterile Multi-Action Relief Drops

    Rite Aid is recalling Multi-Action Relief Drops nationwide due to non-sterility concerns. The FDA classified this as a Class I recall affecting 9,216 bottles.

    Product
    Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-2254-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0303-2024·2024-02-14

    FDA recalls non-sterile EQUATE lubricant eye drops nationwide

    Walmart's EQUATE brand Hydration PF Lubricant Eye Drops are being recalled due to non-sterility. This FDA Class I recall affects 33,984 bottles distributed nationwide.

    Product
    EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.34 FL OZ (10 mL) bottles, Distributed by: Walmart Inc., Bentonville, AR 72712, NDC 79903-168-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0305-2024·2024-02-14

    FDA Recalls CVS Health Lubricating Eye Drops Due to Non-Sterility

    CVS Health brand Lubricating Eye Drops are being recalled due to non-sterility. The FDA Class I recall affects 45,408 bottles distributed nationwide.

    Product
    CVS Health brand Mild Moderate Lubricating Eye Drops (Propylene glycol 400 0.25%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-711-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0298-2024·2024-02-14

    Drug: CVS Health Lubricant Gel Drops recalled nationwide for non-sterility

    CVS Health Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) are being recalled nationwide due to non-sterility concerns. All lots of the product in single and twin pack bottles are affected.

    Product
    CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-704-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-704-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0299-2024·2024-02-14

    Drug recall: DRY EYE RELIEF eye drops for non-sterility

    FDA recalls DRY EYE RELIEF eye drops nationwide due to non-sterility. The ophthalmic product distributed in 23,208 bottles affects all lots. Consumers should discontinue use immediately.

    Product
    DRY EYE RELIEF — DRY EYE RELIEF (CARBOXYMETHYLCELLULOSE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0290-2024·2024-02-14

    CVS Health Lubricant Eye Drops Recalled Due to Non-Sterility

    CVS Health brand Lubricant Eye Drops are being recalled due to non-sterility concerns. Kilitch Healthcare India Limited initiated this voluntary recall affecting 386,256 bottles distributed nationwide.

    Product
    CVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-702-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-702-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 028
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0296-2024·2024-02-14

    CVS Multi Action Relief Drops Recalled for Non-Sterility

    CVS brand Multi Action Relief Drops are being recalled nationwide due to non-sterility, which could allow microbial contamination in the product. The voluntary recall covers all lots of the eye drops.

    Product
    CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%) packaged in 0.5 FL OZ (15mL) bottles, Distributed by CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-706-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0304-2024·2024-02-14

    Drug Recall: Non-Sterile Lubricant Eye Drops Distributed Nationwide

    Rite Aid is recalling lubricant eye drops due to non-sterility concerns. All lots of the Carboxymethylcellulose Sodium 0.5% product are affected.

    Product
    LUBRICANT EYE DROPS (Carboxymethylcellulose Sodium 0.5%), packaged 0.5 FL OZ (15mL) bottles (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0300-2024·2024-02-14

    Target Lubricant Eye Drops Recalled for Non-Sterility

    Target brand High Performance Lubricant Eye Drops have been recalled nationwide due to non-sterility. The manufacturer, Kilitch Healthcare India Limited, initiated the voluntary FDA Class I recall affecting 401,568 bottles.

    Product
    Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%) a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 11673-522-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 11673-522-30), Distributed by: Target Corporation Minneapolis, MN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0297-2024·2024-02-14

    Eye Irritation Relief Drops Recalled Nationwide for Non-Sterility

    Eye Irritation Relief drops are being recalled nationwide due to non-sterility. The FDA classified this as a Class I recall affecting 10,944 bottles distributed across all production lots.

    Product
    EYES IRRITATION RELIEF — EYES IRRITATION RELIEF (POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0301-2024·2024-02-14

    FDA recalls Leader brand Lubricant Eye Drops nationwide for non-sterility

    Leader brand Lubricant Eye Drops (0.6% Propylene glycol) are recalled nationwide due to non-sterility concerns. Consumers should discontinue use immediately.

    Product
    Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged in 0.33 FL OZ (10 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0587-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0302-2024·2024-02-14

    Drug recall: Velocity Pharma Lubricating Eye Drops non-sterility risk

    Kilitch Healthcare is recalling all lots of Velocity Pharma Lubricating Eye Drop due to non-sterility issues. The product was distributed nationwide; consumers should stop using it immediately.

    Product
    Velocity Pharma brand Lubricating Eye Drop (Propylene glycol Eye Drops 0.6%), packaged in 3 bottles of 0.33 FL OZ (10 mL) each, Velocity Pharma, NDC 76168-502-30
    Category
    Drug
    Distribution
    Distributed nationwide