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    Explainer

    Eye drop safety: how to check if your drops are recalled

    Eye drops are meant to be sterile, and contaminated drops can cause eye infections that FDA says could lead to blindness or death.[1] Most US eye drop recalls in 2026 cited "lack of assurance of sterility", and you can check whether your drops are affected by searching FDA's Enforcement Report for the brand and lot number.[2][3]

    Editor reviewedStrict sourcingUpdated ExplainerHealth and medicine, Tech policy

    Eye drops go directly onto the surface of the eye, so they are made to be sterile. FDA warned in 2023 that contaminated artificial tears raise the risk of eye infections that could result in blindness or death.[1] Since then, many eye drop products have been recalled, including several large recalls in 2026.[4][5][6] This page explains what the recall notices mean and how to check your own drops.

    This page is not medical advice. If you have symptoms of an eye infection or questions about your drops, talk to a clinician or pharmacist; CDC lists discharge, eye pain, redness, light sensitivity and blurry vision among the warning signs.[7][8]

    Why sterility matters

    Germs that get into a bottle of eye drops can go straight into your eye. In 2022–23, contaminated artificial tears were linked to an outbreak of a drug-resistant bacterium found in 81 patients in 18 US states. Fourteen lost vision, four had an eye removed and four died within a month of a positive test.[9][10] Some recalls are precautionary: Oasis Medical recalled its preservative-free drops “out of an abundance of caution” after FDA inspection observations at the manufacturer.[11]

    The 2022–23 outbreak strain was a carbapenem-resistant Pseudomonas aeruginosa carrying VIM and GES enzymes, not previously reported in the US.[12] Isolates were resistant to most antibiotic classes tested, including carbapenems, fluoroquinolones and polymyxins.[13] CDC recovered the strain from opened bottles, and FDA found bacterial contamination in unopened bottles.[14][15] FDA’s December 2023 draft guidance on topical eye products addresses microbiological considerations and container closure design.[16]

    What the recall wording means

    Most 2026 eye drop recalls give the reason “lack of assurance of sterility”.[17][2][18] In several cases the recalling firm said the trigger was a problem FDA found when it inspected the factory.[19][11][20] A stronger wording, “non-sterility”, has been used when contamination was actually found, as in the 2023 EzriCare recall.[15]

    FDA sorts recalls into three classes. Class I means a reasonable probability of serious harm or death.[21] Class II means temporary or medically reversible harm is possible, or serious harm is remote.[22] Class III means harm is unlikely.[23] The large 2026 recalls were Class II; the EzriCare, late-2023 store-brand and Systane Ultra PF recalls were Class I.[2][15][24][25] See fda-recall-process for how classification works.[26]

    Preservatives and packaging

    Multi-dose bottles are opened and used many times. FDA said the EzriCare maker sold multi-use bottles without an adequate preservative, and also lacked proper microbial testing and tamper-evident packaging controls.[27] EzriCare was a preservative-free product sold in multidose bottles.[28] Single-use vials avoid repeated opening, but they are not immune to manufacturing failures: Alcon’s Systane Ultra PF vials were recalled as Class I for non-sterility in 2025.[25]

    How to check whether your drops are recalled

    1. Find the details on your product. Recall records identify products by brand, product name and lot number, with expiry dates.[29][30]
    2. Search FDA’s Enforcement Report. It includes all recalls FDA monitors, and can be searched or downloaded weekly; recalls pending classification are listed too.[26][3][31]
    3. Do not rely only on press releases. FDA’s main recalls page lists only recalls with press releases or public notices.[32]
    4. Set up alerts. FDA lets you subscribe to Enforcement Report emails by keyword, such as a brand name or “sterility”.[33]
    5. Check store brands carefully. One manufacturer’s recall can cover many store brands: K.C. Pharmaceuticals’ recall covered products sold as Walgreens, Kroger, LEADER, Good Sense and others.[34]

    Our eye drop recalls tracker lists the main recalls with links to FDA records.[35]

    Buying and reporting

    FDA recommends buying eye products only from reputable retailers such as state-licensed pharmacies.[36] In 2024 it warned about copycat products sold online that imitated Bausch + Lomb’s Lumify; one was contaminated with Burkholderia cepacia complex bacteria.[37] If you have a reaction or a quality problem, FDA asks patients and clinicians to report it to MedWatch.[38]

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    Questions readers ask

    How do I know if my eye drops have been recalled?

    FDA's Enforcement Report lists every recall FDA monitors and can be searched, downloaded weekly or queried through an API. Recall entries list products by name and lot number, so compare them with your bottle and carton. FDA also offers email alerts by keyword.[26][3][33][29]

    What does "lack of assurance of sterility" mean?

    It is the reason given in most 2026 eye drop recalls. Recalling firms have tied several of them to manufacturing problems found during FDA inspections, rather than to confirmed contamination of the product.[2][19][11]

    Are preservative-free eye drops riskier?

    Not necessarily. FDA said the EzriCare maker sold multi-use bottles without an adequate preservative. Preservative-free single-use vials have also been recalled for non-sterility, such as Systane Ultra PF in 2025.[27][25]

    What are the symptoms of an eye infection from contaminated drops?

    CDC lists yellow, green or clear discharge, eye pain or discomfort, redness of the eye or eyelid, a feeling of something in the eye, increased light sensitivity, and blurry vision.[7]

    Where is it safest to buy eye drops?

    FDA recommends buying eye products only from reputable retailers such as state-licensed pharmacies and being wary of online sellers making false claims.[36]

    How do I report a problem with eye drops?

    FDA encourages patients and health care professionals to report adverse events or quality problems with medicines to its MedWatch program.[38]

    Sources

    · 38 claims from 3 publishers

    Each numbered claim is a statement we checked against the sources listed with it. Tap a number in the text to see its sources in place.

    1. [1]

      On 2 February 2023 FDA warned consumers and health care practitioners to stop using EzriCare Artificial Tears and Delsam Pharma's Artificial Tears because of potential bacterial contamination, saying contaminated artificial tears raise the risk of eye infections that could cause blindness or death. confirmedas of 2026-10-11

    2. [2]

      Sterling Pharmaceutical Services of Dupo, Illinois, began a nationwide recall of eye-care products on 20 August 2026 for lack of assurance of sterility; FDA classified it Class II on 21 September and posted it on 30 September 2026. confirmedas of 2026-10-11

    3. [3]

      Enforcement Report data can be accessed through a weekly report, quick and advanced search, and an application programming interface (API). confirmedas of 2026-10-11

    4. [4]

      FDA's records for the K.C. Pharmaceuticals recall list quantities from 74,016 to 1,023,096 bottles per product, about 3.1 million bottles in total. confirmedas of 2026-10-11

    5. [5]

      FDA's records for the Rohto recall list nearly 12 million cartons across the eight products, including 6,076,306 cartons of Rohto Cooling Eye Drops Max Strength. confirmedas of 2026-10-11

    6. [6]

      Insight Pharmaceuticals, a Prestige Consumer Healthcare company, began a nationwide recall of Clear Eyes Redness Relief eye drops on 15 September 2026 for lack of assurance of sterility; FDA classified it Class II on 23 September and posted it on 30 September 2026, listing 2,356,248 bottles. confirmedas of 2026-10-11

    7. [7]

      CDC lists eye infection symptoms as yellow, green or clear discharge, eye pain or discomfort, redness of the eye or eyelid, a feeling of something in the eye, increased light sensitivity, and blurry vision. confirmedas of 2023-05-15

    8. [8]

      CDC advised that people who had used the recalled products and had signs or symptoms of an eye infection should seek medical care immediately. confirmedas of 2023-05-15

    9. [9]

      As of 15 May 2023, CDC and health departments had identified 81 patients in 18 US states with the outbreak strain. confirmedas of 2023-05-15

    10. [10]

      CDC reported adverse outcomes including 14 patients with vision loss, 4 with surgical removal of an eyeball, and 4 deaths within 30 days of a positive clinical culture. confirmedas of 2023-05-15

    11. [11]

      Oasis Medical recalled Oasis Tears PF preservative-free lubricant eye drops from 27 April 2026 as a precaution after FDA observations during an inspection of Excelvision. confirmedas of 2026-10-11

    12. [12]

      The 2022–23 outbreak was caused by an extensively drug-resistant strain of Pseudomonas aeruginosa (VIM-GES-CRPA) that had never been reported in the United States before. confirmedas of 2023-05-15

    13. [13]

      Outbreak isolates tested by public health laboratories were not susceptible to a long list of antibiotics, including carbapenems, fluoroquinolones and polymyxins; a small subset tested was susceptible to cefiderocol. confirmedas of 2023-05-15

    14. [14]

      CDC found the outbreak strain in opened EzriCare bottles from multiple lots, and FDA testing found bacterial contamination in unopened bottles. confirmedas of 2023-05-15

    15. [15]

      FDA classified the EzriCare and Delsam Pharma artificial tears recall as Class I after its analysis found bacterial contamination in unopened products; the recall covered 400,008 bottles. confirmedas of 2026-10-11

    16. [16]

      In December 2023 FDA issued draft guidance on quality considerations for topical eye products that covers microbiological considerations and the design of container closure systems. confirmedas of 2026-10-11

    17. [17]

      K.C. Pharmaceuticals of Pomona, California, began a nationwide voluntary recall of eight over-the-counter eye-drop products on 3 March 2026 for lack of assurance of sterility; FDA classified it Class II and posted it on 8 April 2026. confirmedas of 2026-10-11

    18. [18]

      Rohto-Mentholatum (Vietnam) began a nationwide recall of eight Rohto Cooling Eye Drops products on 14 July 2026 for lack of assurance of sterility; FDA classified it Class II on 23 July and posted it on 29 July 2026. confirmedas of 2026-10-11

    19. [19]

      Thea Pharma recalled iVIZIA Sterile Lubricant Eye Drops, made in France, from 23 April 2026, after FDA found manufacturing (CGMP) deviations during an inspection of the manufacturer. confirmedas of 2026-10-11

    20. [20]

      Alcon recalled lots of GenTeal Tears lubricant eye gel and Systane Night Gel from 21 April 2026, citing FDA inspection observations that it believes may affect product quality. confirmedas of 2026-10-11

    21. [21]

      A Class I recall is a situation where there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death. confirmedas of 2026-10-11

    22. [22]

      A Class II recall is a situation where the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse consequences is remote. confirmedas of 2026-10-11

    23. [23]

      A Class III recall is a situation where using or being exposed to the product is not likely to cause adverse health consequences. confirmedas of 2026-10-11

    24. [24]

      In late 2023 FDA classified further eye-drop recalls as Class I, including Cardinal Health's LEADER-brand drops after FDA found insanitary conditions and positive bacterial tests at the manufacturing facility, and Kilitch Healthcare India's drops sold under brands such as Target's Up&Up and CVS Health. confirmedas of 2026-10-11

    25. [25]

      Alcon recalled Systane Lubricant Eye Drops Ultra PF single-use vials (55,960 boxes) for non-sterility; the recall began on 18 December 2024 and FDA classified it Class I on 13 January 2025. confirmedas of 2026-10-11

    26. [26]

      The FDA Enforcement Report lists all recalls monitored by FDA once they are classified, and recall classifications are usually set after the firm supplies the information FDA needs to assess the risk. confirmedas of 2026-10-11

    27. [27]

      FDA said it recommended the Global Pharma recall because of manufacturing violations including a lack of appropriate microbial testing, multi-use bottles without an adequate preservative, and a lack of proper tamper-evident packaging controls. confirmedas of 2026-10-11

    28. [28]

      Patients reported more than 10 brands of artificial tears, but EzriCare Artificial Tears, a preservative-free over-the-counter product sold in multidose bottles, was the brand most commonly reported. confirmedas of 2023-05-15

    29. [29]

      Prestige Brands recalled one lot (2552A) of Clear Eyes Maximum Itchy Eye Relief, 39,060 bottles, citing lack of assurance of sterility due to potential contamination; the recall began on 29 July 2026 and FDA posted it as Class II on 19 August 2026. confirmedas of 2026-10-11

    30. [30]

      Besides Walgreens, the Sterling recall covered products distributed by AvKARE, Cameron Pharmaceuticals, Reliable-1 Laboratories and TRP Company, with expiry dates running from August 2026 to July 2027. confirmedas of 2026-10-11

    31. [31]

      Since 15 June 2017 the Enforcement Report has also listed recalls that are pending classification, to alert the public sooner. confirmedas of 2026-10-11

    32. [32]

      FDA's Recalls, Market Withdrawals and Safety Alerts page lists recalls drawn from press releases and public notices, and FDA states that not all recalls have press releases or appear there. confirmedas of 2026-10-11

    33. [33]

      FDA offers email notifications of new and updated recalls in the Enforcement Report, including alerts by keyword such as a brand name or a recall reason like "sterility". confirmedas of 2026-10-11

    34. [34]

      The K.C. Pharmaceuticals products were sold under store and distributor brands including Walgreens, Kroger, LEADER (Cardinal Health), Good Sense, TopCare, Best Choice and Rugby. confirmedas of 2026-10-11

    35. [35]

      As of 11 October 2026, FDA's openFDA drug enforcement dataset had last been updated on 30 September 2026. confirmedas of 2026-10-11

    36. [36]

      FDA recommends buying eye products only from reputable retailers such as state-licensed pharmacies and being wary of online sellers making false claims. confirmedas of 2026-10-11

    37. [37]

      In January 2024 FDA warned consumers not to buy or use South Moon, Rebright or FivFivGo eye drops, unapproved copycats easily mistaken for Bausch + Lomb's Lumify; FDA testing found South Moon contaminated with Burkholderia cepacia complex bacteria. confirmedas of 2026-10-11

    38. [38]

      FDA encourages patients and health care professionals to report adverse events or quality problems with medicines to its MedWatch program. confirmedas of 2026-10-11

    Revision history (1)
    1. Page created.

    Created Oct 11, 2026. Last reviewed by an editor on Oct 11, 2026. Next scheduled review: Jan 11, 2027.

    Cite this page

    "Eye drop safety: how to check if your drops are recalled." ContentLora, updated Oct 11, 2026. https://contentlora.com/explain/eye-drop-safety-explained

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