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    Eye drop recalls 2026: live tracker of FDA recalls

    In 2026 several large US eye drop recalls were posted, most for "lack of assurance of sterility": K.C. Pharmaceuticals' store-brand drops (about 3.1 million bottles), Rohto Cooling Eye Drops (nearly 12 million cartons), Sterling Pharmaceutical Services' Walgreens and other lubricant drops, and Clear Eyes Redness Relief.[1][2][3][4] All four were Class II recalls, meaning FDA judged the probability of serious harm to be remote.[5]

    Editor reviewedStrict sourcingUpdated DevelopingHealth and medicine, Tech policy

    What we know

    • Sterling Pharmaceutical Services' recall covers nine products and 747,844 units, mostly Walgreens lubricant drops[15]
    • Clear Eyes Redness Relief was recalled from 15 September 2026; FDA lists 2,356,248 bottles[4]
    • Rohto's July 2026 recall covers nearly 12 million cartons of eight Rohto Cooling Eye Drops products[2]
    • K.C. Pharmaceuticals' March 2026 recall covers about 3.1 million bottles of store-brand drops[1]
    • The 2026 recalls listed here are Class II, where serious harm is judged remote[5]
    • FDA's openFDA recall dataset was last updated on 30 September 2026[23]

    What we don't know yet

    • Whether any illnesses are linked to the 2026 recalls; the FDA enforcement records cited here do not report illness counts
    • Which eye drop recalls FDA will post in Enforcement Reports after 30 September 2026
    • Whether the April 2026 recalls of several French-made lubricant drops trace back to a single manufacturer; only the Oasis recall names one (Excelvision)
    • When FDA will finalise its December 2023 draft guidance on eye product quality
    Story status

    Story status

    State
    developing
    Started
    2023-02-02
    Timeline entries
    16
    Last entry

    Timeline data (JSON)

    US eye drop recalls have come in waves since a deadly 2023 outbreak linked to contaminated artificial tears.[6][7] In 2026 the largest recalls involved store-brand, Rohto, Clear Eyes and Walgreens products, most for “lack of assurance of sterility”.[8][9][3][4] This tracker lists recalls from FDA’s enforcement records, newest first in the timeline, through 11 October 2026.

    This page is not medical advice. If you have used recalled drops and have eye pain, redness, discharge or blurry vision, talk to a clinician; in the 2023 outbreak CDC advised anyone with such symptoms to seek medical care immediately.[10][11]

    The 2026 recalls at a glance

    RecallBeganProductsQuantity listed by FDAClass
    K.C. Pharmaceuticals3 Mar 20268 store-brand drops[12]~3.1 million bottles[1]II[8]
    Rohto-Mentholatum (Vietnam)14 Jul 20268 Rohto Cooling Eye Drops[9]~12 million cartons[2]II[9]
    Prestige Brands29 Jul 2026Clear Eyes Maximum Itchy Eye Relief, lot 2552A39,060 bottles[13]II[13]
    Sterling Pharmaceutical Services20 Aug 20269 lubricant products incl. Walgreens[14]747,844 units[15]II[3]
    Insight Pharmaceuticals (Prestige)15 Sep 2026Clear Eyes Redness Relief2,356,248 bottles[4]II[4]

    Quantities are what the recalling firms reported to FDA and are summed across each recall’s product entries; units differ (bottles, packs, cartons).[1][2][15]

    The April 2026 cluster

    In a three-week span in April 2026, five lubricant eye products were recalled for lack of assurance of sterility: Freshkote, Optase Dry Eye Intense, GenTeal Tears gel and Systane Night Gel, iVIZIA, and Oasis Tears PF.[16][17][18][19] Thea Pharma said its iVIZIA recall followed manufacturing deviations FDA found while inspecting the manufacturer, and Oasis said its recall followed FDA observations at Excelvision.[18][19] Alcon cited FDA inspection observations that it believes may affect product quality.[17] The FDA records do not say whether the other products share a manufacturer.[16]

    How to read these dates

    A recall usually starts when the firm acts, and FDA classifies and posts it in its weekly Enforcement Report later, after the firm supplies the information FDA needs.[20][21] The timeline uses the date each recall began, and notes when FDA posted it. FDA’s public recalls page lists only recalls with press releases or public notices, so many eye drop recalls appear only in the Enforcement Report.[22] As of 11 October 2026, FDA’s openFDA recall data had last been updated on 30 September 2026.[23]

    For background on recall classes and how to check your own drops, see fda-recall-process and eye drop safety explainer.[24][25]

    Earlier recalls (2023–2025)

    The 2023 outbreak was tied to EzriCare and Delsam Pharma artificial tears made by Global Pharma. FDA found bacterial contamination in unopened bottles and classified the recall as Class I.[26] The full story is in EzriCare outbreak. Late in 2023, further Class I recalls covered LEADER, Up&Up, CVS Health and other store-brand drops.[27] In January 2025 FDA classified Alcon’s recall of Systane Ultra PF single-use vials as Class I for non-sterility.[28]

    Timeline

    16 confirmed

    1. confirmed

      No newer eye drop recalls in FDA's openFDA data, last updated 30 September[23][22]

      Recalls posted in FDA's weekly Enforcement Reports after that date are not yet reflected here.

    2. confirmed

      Clear Eyes Redness Relief recalled nationwide[4]

      FDA lists 2,356,248 bottles and posted the Class II recall on 30 September 2026.

    3. confirmed

      Sterling Pharmaceutical Services recalls Walgreens and other lubricant eye drops[3][15][14]

      Nine products, 747,844 units. FDA classified it Class II on 21 September and posted it on 30 September 2026.

    4. confirmed

      One lot of Clear Eyes Maximum Itchy Eye Relief recalled[13]

      Lot 2552A, 39,060 bottles, posted as Class II on 19 August 2026.

    5. confirmed

      Rohto recalls eight Rohto Cooling Eye Drops products[9][2]

      FDA's records list nearly 12 million cartons. FDA posted the Class II recall on 29 July 2026.

    6. confirmed

      Oasis Tears PF recalled after FDA inspection of Excelvision[19]

    7. confirmed

      iVIZIA lubricant eye drops recalled after FDA inspection of manufacturer[18]

    8. confirmed

      Alcon recalls GenTeal Tears gel and Systane Night Gel lots[17]

      Alcon cited FDA inspection observations that it believes may affect product quality.

    9. confirmed

      Freshkote and Optase lubricant drops recalled[16]

    10. confirmed

      K.C. Pharmaceuticals recalls about 3.1 million bottles of store-brand eye drops[8][1][12]

      Brands included Walgreens, Kroger, LEADER, Good Sense, TopCare, Best Choice and Rugby. FDA posted the Class II recall on 8 April 2026.

    11. confirmed

      AvKARE lubricant eye products made by BRS Analytical Services recalled[32]

    12. confirmed

      Systane Ultra PF vials recall classified Class I[28]

      Alcon recalled 55,960 boxes of single-use vials for non-sterility.

    13. confirmed

      FDA warns about contaminated copycat Lumify eye drops[31]

    14. confirmed

      Class I recalls of LEADER and other store-brand eye drops begin[27]

      FDA cited insanitary conditions and positive bacterial tests at the manufacturing facility.

    15. confirmed

      CDC counts 81 patients in 18 states in the artificial tears outbreak[30][7]

      Reported outcomes included 14 patients with vision loss, 4 eyeball removals and 4 deaths within 30 days of a positive culture.

    16. confirmed

      FDA warns consumers to stop using EzriCare and Delsam Pharma artificial tears[6][29]

      The products were linked to an outbreak of an extensively drug-resistant Pseudomonas aeruginosa strain never before reported in the US.

    Next in the crash course

    More in Health & medicine

    Developing in Health

    Questions readers ask

    Which eye drops were recalled in 2026?

    FDA records show recalls of K.C. Pharmaceuticals' store-brand drops (sold under names such as Walgreens, Kroger and LEADER), Rohto Cooling Eye Drops, Clear Eyes Maximum Itchy Eye Relief (one lot), Walgreens and other lubricant drops made by Sterling Pharmaceutical Services, and Clear Eyes Redness Relief, plus several smaller lubricant-drop recalls in April 2026.[12][9][13][15][4][16]

    Why were the eye drops recalled?

    Most 2026 eye drop recalls cite "lack of assurance of sterility". Some firms linked their recalls to problems FDA found during inspections of the manufacturer.[3][8][18][19]

    How serious is a Class II recall?

    FDA uses Class II when a product may cause temporary or medically reversible health problems, or when the probability of serious harm is remote. Class I is reserved for cases with a reasonable probability of serious harm or death.[5][24]

    Were the Walgreens eye drops recalled in October 2026?

    The Sterling Pharmaceutical Services recall that includes Walgreens Lubricant Eye Drops began on 20 August 2026 and was posted by FDA on 30 September 2026. It lists 301,114 bottles and 199,600 twin packs of the Walgreens product.[3][15]

    What should I do if my eye drops are recalled?

    In earlier outbreaks CDC advised people who used recalled drops and had signs of an eye infection to seek medical care immediately. Symptoms include discharge, eye pain, redness, light sensitivity and blurry vision. FDA asks people to report problems to MedWatch.[10][11][33]

    Sources

    · 33 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]

      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

    2. [2]

      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

    3. [3]

      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

    4. [4]

      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

    5. [5]

      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

    6. [6]

      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

    7. [7]

      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

    8. [8]

      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

    9. [9]

      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

    10. [10]

      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

    11. [11]

      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

    12. [12]

      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

    13. [13]

      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

    14. [14]

      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

    15. [15]

      FDA's records for the Sterling recall list nine products totalling 747,844 units, including 301,114 bottles and 199,600 twin packs of Walgreens Lubricant Eye Drops. confirmedas of 2026-10-11

    16. [16]

      In April 2026 Harrow Eye recalled 50,900 units of Freshkote lubricant eye drops and Scope Health recalled Optase Dry Eye Intense Drops, both for lack of assurance of sterility. confirmedas of 2026-10-11

    17. [17]

      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

    18. [18]

      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

    19. [19]

      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

    20. [20]

      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

    21. [21]

      FDA notes that firms often announce voluntary recalls well before FDA completes its classification and posts the recall to the Enforcement Report. confirmedas of 2026-10-11

    22. [22]

      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

    23. [23]

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

    24. [24]

      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

    25. [25]

      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

    26. [26]

      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

    27. [27]

      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

    28. [28]

      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

    29. [29]

      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

    30. [30]

      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

    31. [31]

      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

    32. [32]

      BRS Analytical Services recalled five AvKARE-distributed lubricant eye products from 23 April 2025, citing manufacturing deviations and lack of assurance of sterility. confirmedas of 2026-10-11

    33. [33]

      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: Oct 14, 2026.

    Cite this page

    "Eye drop recalls 2026: live tracker of FDA recalls." ContentLora, updated Oct 11, 2026. https://contentlora.com/events/eye-drop-recalls-tracker

    Spotted an error? Suggest a correction or emailcorrections@contentlora.com.

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