Over the past couple of months, the U.S. Food and Drug Administration (FDA) has made several recalls of artificial tears and other ophthalmic products because of sterility concerns and possible contamination. These recalls are on a range of brands and products, some of which have been associated with serious health problems, such as infections and vision problems. A detailed summary of the recalled products, reasons why they were recalled, and what consumers should do follows.
Major recalls of artificial tears and eye care products
1. BRS Analytical Service/AvKARE Recall:
On April 23, 2025, BRS Analytical Service, LLC, in collaboration with distributor AvKARE, initiated a voluntary recall of over 75,000 cases of five different ophthalmic solutions, including artificial tears and eye drops. These products were distributed nationwide between May 26, 2023, and April 21, 2025. The recall was prompted by manufacturing deviations from Current Good Manufacturing Practice (cGMP) standards, raising concerns about product sterility and quality. The FDA classified this as a Class II recall, indicating that the products may cause temporary or medically reversible adverse health consequences.
2. Global Pharma Healthcare: EzriCare and Delsam Pharma
In February 2023, Global Pharma Healthcare issued a voluntary recall of all lots of Artificial Tears Lubricant Eye Drops it had sold under the EzriCare and Delsam Pharma brand names.
The move followed a report that those products were linked to a multi-state outbreak of infections caused by drug-resistant Pseudomonas aeruginosa. As of the date of recall, 55 reports of adverse events were received, including eye infections, permanent loss of vision, and one death due to a bloodstream infection.
3. Kilitch Healthcare India Limited: Multiple Retail Brands
In October 2023, Kilitch Healthcare India Limited voluntarily recalled 27 eye drop products sold under various retail brands, including CVS Health, Rite Aid, Target’s Up & Up, Walmart’s Equate, Leader (Cardinal Health), Rugby (Cardinal Health), and Velocity Pharma.
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The FDA’s inspection revealed unsanitary conditions and bacterial contamination in critical drug production areas. All lots with expiration dates from November 2023 through September 2025 were affected.
4. Systane Lubricant Eye Drops Ultra P-F by Alcon Laboratories:
Alcon Laboratories recalled its Systane Lubricant Eye Drops Ultra P-F during December 2024 due to potential fungal contamination present in sealed vials. The recall was restricted to a box containing 25 single-use vials of the lot number 10101 with an expiration date of September 2025. No side effects had been experienced at the time of the recall.
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5. Other significant recalls
- Pharmedica USA: Recalled two lots of “Purely Soothing, 15% MSM Drops” due to non-sterility concerns.
- Apotex Corp: Recalled six lots of “Brimonidine Tartrate Ophthalmic Solution, 0.15%” used for treating open-angle glaucoma or ocular hypertension, due to cracks in some bottle caps that could compromise sterility.
- Dr. Berne’s Whole Health Products: Recalled many products, including “MSM Drops 5% and 15% Solution,” “Organic Castor Oil Eye Drops,” and “MSM Mist 15% Solution,” after FDA testing found contamination by bacteria and fungus.
- Teva Pharmaceuticals: Recalled lots of “Clear Eyes Once Daily, Eye Allergy Itch Relief” due to failure in an impurities test.
Recommendations for consumers:
- Cease use immediately: If you possess any of the recalled products, stop using them immediately to prevent potential health risks.
- Check lot numbers and expiration dates: Verify if your eye care products are part of the recalls by checking the lot numbers and expiration dates provided in the recall notices.
- Consult healthcare providers: If you have used any of the recalled products and experience symptoms such as eye pain, redness, blurred vision, or discharge, seek medical attention promptly.
- Proper disposal: Dispose of recalled products following the guidelines provided by the FDA or return them to the place of purchase if instructed.
The recent recalls of artificial tears and other ophthalmic products remind us of the importance of quality manufacturing practices and consumer vigilance. Consumers are urged to stay informed about product recalls and adhere to safety precautions to protect their eye health. For the most current information, check the FDA’s official website regularly and consult healthcare professionals for safe eye care products.
