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    EzriCare artificial tears outbreak (2022–2023)

    In 2022–23 an extensively drug-resistant strain of Pseudomonas aeruginosa, never before seen in the US, was found in 81 patients in 18 states; most reported using artificial tears, and EzriCare Artificial Tears was the brand most commonly reported.[1][2][3] CDC reported 14 patients with vision loss, 4 eyeball removals and 4 deaths within 30 days, and FDA found bacteria in unopened bottles.[4][5]

    Editor reviewedStrict sourcingUpdated DevelopingHealth and medicine, Tech policy

    What we know

    • The outbreak strain, VIM-GES-CRPA, had never been reported in the US before[1]
    • CDC counted 81 patients in 18 states as of 15 May 2023[2]
    • Outcomes included 14 patients with vision loss, 4 enucleations and 4 deaths within 30 days[4]
    • FDA found bacterial contamination in unopened products and classified the recall Class I[5]
    • FDA cited missing microbial testing and multi-use bottles without an adequate preservative[11]
    • The manufacturer, Global Pharma, was placed on FDA import alert[12]

    What we don't know yet

    • The final case count, since CDC's last update cited here was dated 15 May 2023
    • How many deaths were caused by the infection itself rather than by patients' other illnesses; CDC reported deaths within 30 days of a positive culture
    Story status

    Story status

    State
    concluded
    Started
    2023-02-02
    Timeline entries
    5
    Last entry

    Timeline data (JSON)

    In early 2023 FDA warned consumers to stop using EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears, saying contaminated artificial tears could cause eye infections leading to blindness or death.[6] Later recalls are tracked in eye drop recalls tracker.[7]

    This page is a historical summary, not medical advice; anyone with eye infection symptoms after using eye drops should seek care from a clinician, as CDC advised during the outbreak.[8]

    The outbreak

    The outbreak strain was a carbapenem-resistant Pseudomonas aeruginosa producing VIM and GES enzymes (VIM-GES-CRPA), a strain that had never been reported in the United States before.[1] As of 15 May 2023, CDC and state and local health departments had identified 81 patients in 18 states.[2] Reported adverse outcomes included 14 patients with vision loss, 4 with enucleation (surgical removal of the eyeball) and 4 deaths within 30 days of a positive clinical culture.[4]

    Patients reported more than 10 brands of artificial tears. EzriCare, a preservative-free over-the-counter product in multidose bottles, was the most commonly reported.[3] CDC found the outbreak strain in opened EzriCare bottles from multiple lots, and FDA found bacterial contamination in unopened bottles.[9]

    The isolates were extensively drug-resistant. Those tested by public health laboratories were not susceptible to carbapenems, fluoroquinolones, polymyxins and other antibiotics, although a small tested subset was susceptible to cefiderocol.[10]

    FDA’s response

    FDA said it recommended the recall because of manufacturing violations at Global Pharma Healthcare: a lack of appropriate microbial testing, multi-use bottles without an adequate preservative, and a lack of proper controls on tamper-evident packaging.[11] It placed the company on import alert, which blocks its products from entering the US.[12] On 21 February 2023 FDA added Delsam Pharma’s Artificial Eye Ointment to its warning, and the firm agreed to recall it.[13] FDA classified the artificial tears recall as Class I, its most serious category, after finding bacteria in unopened products.[5][14]

    What followed

    Later in 2023, FDA classified further eye drop recalls as Class I, including LEADER-brand drops after it found insanitary conditions and positive bacterial tests at the manufacturing facility.[15] In December 2023 FDA issued draft guidance on quality considerations for topical eye products, covering microbiological considerations and container design.[16] For practical advice on checking drops, see eye drop safety explainer.[17]

    Timeline

    5 confirmed

    1. confirmed

      FDA classifies the artificial tears recall as Class I[5]

      FDA's analysis found bacterial contamination in unopened products.

    2. confirmed

      CDC update counts 81 patients in 18 states[2][4]

    3. confirmed

      FDA extends its warning to Delsam Pharma's Artificial Eye Ointment[13]

      The firm agreed to recall the ointment the next day.

    4. confirmed

      FDA warns consumers to stop using the products immediately[6][11][12]

      FDA cited manufacturing violations and placed the manufacturer on import alert.

    5. confirmed

      Global Pharma begins recall of EzriCare and Delsam Pharma artificial tears[5]

      FDA's records list 400,008 bottles across the products.

    More in Health & medicine

    Developing in Health

    Questions readers ask

    What happened with EzriCare eye drops?

    EzriCare Artificial Tears was the brand most commonly reported by patients in a 2022–23 outbreak of an extensively drug-resistant Pseudomonas aeruginosa strain. The manufacturer, Global Pharma, recalled the product, and FDA warned people to stop using it.[3][6]

    How many people were harmed?

    As of 15 May 2023, CDC had identified 81 patients in 18 states. Reported outcomes included 14 patients with vision loss, 4 with surgical removal of an eyeball, and 4 deaths within 30 days of a positive clinical culture.[2][4]

    Why were the drops contaminated?

    FDA cited manufacturing violations, including a lack of appropriate microbial testing, multi-use bottles without an adequate preservative, and poor tamper-evident packaging controls. FDA testing found bacterial contamination in unopened bottles.[11][9]

    Which products were recalled?

    EzriCare Artificial Tears, Delsam Pharma's Artificial Tears and Delsam Pharma's Artificial Eye Ointment, all made by Global Pharma Healthcare.[6][13]

    Sources

    · 17 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]

      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

    2. [2]

      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

    3. [3]

      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

    4. [4]

      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

    5. [5]

      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

    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]

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

    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]

      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

    10. [10]

      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

    11. [11]

      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

    12. [12]

      FDA placed Global Pharma Healthcare Private Limited on import alert, which prevents its products from entering the United States. confirmedas of 2026-10-11

    13. [13]

      On 21 February 2023 FDA extended its warning to Delsam Pharma's Artificial Eye Ointment, and on 22 February Global Pharma agreed to recall it at FDA's recommendation. confirmedas of 2026-10-11

    14. [14]

      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

    15. [15]

      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

    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]

      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

    Revision history (1)
    1. Page created.

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

    Cite this page

    "EzriCare artificial tears outbreak (2022–2023)." ContentLora, updated Oct 11, 2026. https://contentlora.com/events/ezricare-artificial-tears-outbreak

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

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