A Retrospective Analysis of FDA Recalls of Artificial Tear Solutions from 2014-2025

Purpose: To examine all recalls of artificial tears from 2014-2025 in order to identify the most common types, classes of products, and associated reasons for recalls, and to provide guidance on safety. Setting: United States Design: Retrospective Epidemiologic Assessment Methods: Artificial tear recalls from Jan 2014-August 2025 were identified through the FDA Enforcement Report. Data on country of manufacture, classification, ingredients, preservative use, and recall reason was analyzed. The primary endpoints of the study were the most common causes of recall, and the types of products associated with each recall. Secondary endpoints included classification of recall reasons, common ingredients associated with recalls, and the country where the product was manufactured. Results: We identified 110 unique formulations of recalled tears. Most recalls were Class II (81) linked to Lack of Assurance of Sterility (65) that could cause reversible adverse health outcomes and Class I (26) due to Microbial Contamination (25) that could cause permanent adverse outcomes. Preserved (48) and Preservative-free tears (62) were similarly implicated [χ 2 (3, N=110) =6.71, p=0.082]. Most recalled tears were manufactured in the United States (85) and were generic formulations (80). Conclusions Most recalled tears were U.S. generics recalled due to lack of sterility. Preservative free and preserved tears had similar recalls. Overall, recalls tied to confirmed microbial contamination of tears remain rare compared to their prolific use in the United States.