Nearly 200,000 Eye Drop Products Have Been Recalled Nationwide

If you’ve experienced red, itchy, watery eyes during summer, especially in recent years, it’s a trend. Nearly 30% of Americans experience eye symptoms caused by allergens—and that number could grow in coming years due to climate change, as experts warn changing weather patterns “may increase pollen concentrations and extend pollen seasons, heightening health effects for more people.” (Eye health clinicians have also said making conscious efforts to blink during your screen time can help maximize moisture and reduce irritation.)

Meanwhile, if you’ve sought relief from eye drops—over-the-counter or prescription—one U.S. agency says some eye drop products made by a major pharmaceutical manufacturer in a neighboring country may not all be fit for consumer use.

On Wednesday, June 25, the U.S. Food and Drug Administration (FDA) announced a nationwide recall affecting 199,584 total bottles of three different eye solutions: Ketorolac Tromethamine, Azelastine HCL, and Brimonidine Tartrate/Timolol Maleate.

Two of the products—ketorolac tromethamine and azelastine HCL—are prescribed to alleviate itching caused by seasonal allergies. The other, brimonidine tartrate/timolol maleate, works on reducing pressure that’s caused by either glaucoma or hypertension of the eye, according to the Mayo Clinic.

The issue behind the recall, according to the FDA’s report, stems from a “lack of assurance of sterility.” Further details were not provided, nor was an explanation provided for how the problem was discovered. However, a 2024 analysis of FDA-enforced drug recalls between 2012 and 2023 found “lack of assurance in sterility” made up 48% of the reviewed recalls.

The FDA provided these product details:

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL

• Rx Only
• Batch TZ1236
• Expiration Date: 11/30/2025
• 87,840 total bottles

Azelastine HCL Ophthalmic Solution, USP, 0.05%, 6 mL

• Rx Only, Sterile
• Batch VD1654
• Expiration Date: 06/30/2027
• 105,456 total bottles

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL

• Rx Only, Sterile
• Batch VC6058
• Expiration Date: 10/31/2025
• 6,288 total bottles

The bottles were all manufactured by Apotex Inc. in Toronto, Canada, and manufactured for Apotex Corp. in Weston, Florida, per the report. Apotex’s company website says it’s the largest Canadian-based pharmaceutical company.

Though the recall first went into effect on May 28, the FDA didn’t report on its classification until last week. The recall has been labeled as a Class II event, the FDA’s designation for “a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

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