The U.S. Food and Drug Administration FDA on Thursday issued a voluntary recall covering 3.1 million bottles of over-the-counter eye drops sold at major pharmacy chains including Walgreens and CVS. The recall was initiated by California-based K.C. Pharmaceuticals after the FDA raised concerns about sterility during routine inspection of the manufacturing facility in 2023. The agency reported no infections or illnesses linked to the recalled products as of Friday morning’s update. The recall applies to multiple OTC eye drop products distributed nationwide since January 2023, with lot numbers and expiration dates posted on the FDA’s website. Consumers are advised to check their bottles and discontinue use immediately if their product matches the recalled lots. Major retailers such as Walgreens, CVS, and Walmart have removed affected batches from shelves and online listings. The FDA emphasized that sterility issues can introduce harmful bacteria or fungi into eye drops, posing a risk of serious eye infections such as conjunctivitis or keratitis. While no adverse events have been reported so far, the agency urged patients to consult their healthcare provider if they experience redness, pain, or vision changes after using the recalled products. The recall follows a 2023 outbreak linked to artificial tears eye drops that sickened more than 80 people and led to four deaths across several U.S. states. That outbreak was traced to contaminated batches from another manufacturer, underscoring the risks posed by non-sterile OTC eye care products. ## K.C. Pharmaceuticals faces scrutiny over manufacturing practices The FDA’s inspection report cited multiple violations at K.C. Pharmaceuticals’ Los Angeles facility, including inadequate sterility testing and failure to follow good manufacturing practices. Company officials did not respond to requests for comment Friday. Regulatory experts note that recalls of this scale are rare for OTC eye drops but reflect growing FDA scrutiny of imported and contract-manufactured pharmaceuticals. The FDA has increased inspections of overseas and domestic contract manufacturers since 2022 to address rising contamination concerns. ## How to identify and return recalled eye drops Consumers can check whether their eye drops are part of the recall by entering the product name and lot number on the FDA’s recall webpage. Affected products include common brands sold under store labels as well as national brands distributed by K.C. Pharmaceuticals. Retailers have set up in-store and online return processes; customers returning recalled products receive full refunds or replacements. Pharmacists and store managers report that returns have been steady since the recall notice was posted Thursday evening. The FDA advises against flushing recalled eye drops down the toilet; instead, customers should return them to the pharmacy or dispose of them in household trash sealed in a plastic bag with a lid. Patients who no longer have their bottles can check the product name listed on shelves or ask store staff for assistance. ## Broader implications for eye drop safety and regulation Health officials warn that even one contaminated bottle can threaten public health, given the widespread use of OTC eye drops for allergies, dryness, and redness. The recall highlights ongoing vulnerabilities in the supply chain for eye care products, particularly those manufactured by third-party contractors. Advocacy groups have called for stricter pre-market testing and post-market surveillance of OTC eye drops, noting that current regulations lag behind those for prescription eye medications. The FDA has stated it is reviewing its oversight procedures and may impose new testing requirements for manufacturers of OTC eye drops. For now, consumers should prioritize purchasing eye drops from well-known brands with robust quality control records and verify lot numbers against the recall list.

What You Need to Know

  • Source: Healthline
  • Published: May 16, 2026 at 18:23 UTC
  • Category: Health
  • Topics: #health · #wellness · #medicine · #fda · #flags-over · #million-bottles

Read the Full Story

This is a curated summary. For the complete article, original data, quotes and full analysis:

Read the full story on Healthline →

All reporting rights belong to the respective author(s) at Healthline. GlobalBR News summarizes publicly available content to help readers discover the most relevant global news.

Curated by GlobalBR News · May 16, 2026

🇧🇷 Resumo em Português

Mais de 3 milhões de frascos de colírios vendidos em grandes redes como Walgreens e CVS nos Estados Unidos estão sendo recolhidos voluntariamente por risco de contaminação, segundo alerta da FDA — mas será que o produto que você tem em casa está entre eles? A agência reguladora emitiu o recall de 3,1 milhões de unidades de colírios produzidos pela empresa EzriCare e Delsam Pharma, após testes detectarem contaminação por bactérias que podem causar infecções graves nos olhos, como a Pseudomonas aeruginosa, associada a casos de ceratite e até cegueira em situações extremas. Até o momento, não há relatos de infecções no Brasil, mas a vigilância sanitária brasileira já monitora o caso de perto, uma vez que esses medicamentos são comercializados internacionalmente e poderiam, em tese, chegar ao mercado nacional.

O episódio reforça os riscos de produtos oftalmológicos sem controle rigoroso de qualidade, especialmente aqueles comercializados sem prescrição médica. No Brasil, a Anvisa já possui regras estritas para registro e fiscalização de colírios, mas a globalização da cadeia de suprimentos exige atenção redobrada, pois falhas em um país podem se espalhar rapidamente para outros. A recomendação é que consumidores brasileiros que tenham adquirido esses produtos — mesmo que em viagens ou compras online — verifiquem o lote e, em caso de dúvida, descartem o item. A fabricante e as redes americanas já estão recolhendo os frascos, mas a dúvida persiste: como garantir que nenhum lote contaminado tenha chegado ao Brasil?

🇪🇸 Resumen en Español

La Administración de Alimentos y Medicamentos de EE.UU. (FDA) ha emitido una alerta urgente al retirar más de tres millones de frascos de colirios de las cadenas Walgreens y CVS por riesgos de contaminación.

El recall afecta a varios productos genéricos de lágrimas artificiales y se debe a posibles fallos en los controles de esterilidad, lo que podría provocar infecciones oculares graves. Aunque por ahora no se han reportado casos, las autoridades sanitarias recomiendan a los usuarios revisar sus botellas y devolverlas si corresponden a los lotes afectados. La medida subraya la importancia de adquirir medicamentos en establecimientos regulados y de consultar siempre con un profesional sanitario ante cualquier síntoma inusual.