Even More Eye Drops Have Been Recalled Nationwide

Though the process of putting in eye drops can be a bit of a challenge (it takes some practice!), the relief they bring can be well worth the hassle. With over-the-counter and prescription products available to treat everything from pink eye to allergies, it’s not surprising that millions of Americans rely on eye drops daily, according to past survey data.

However, there have already been several eye drop products recalled across the country just this year. A few weeks ago, over 1.8 million eye drops apparently used to relieve dry eye symptoms were recalled due to manufacturing deviations. Soon after, more than 60,000 eye drops were recalled.

Then, on Tuesday, The U.S. Food and Drug Administration (FDA) published a report detailing the recall of bromfenac ophthalmic solution eye drops nationwide. The bottles appear to be available by prescription only.

According to the Mayo Clinic, bromfenac ophthalmic solution is a topical nonsteroidal anti-inflammatory drug (NSAID) that’s typically prescribed to “treat pain or swelling of the eye following cataract surgery.” Cataract surgery is the “most prevalent surgical procedure of all medical specialties,” states a 2021 BMJ Open Ophthalmology study. About 3.7 million Americans undergo this procedure each year.

The FDA report lists “Failed Impurities/Degradation Specifications” as the reason for the recall. The announcement does not go into detail about what those failed specifications were.

A notice from the California State Board of Pharmacy about the recall reads, “This recall is precautionary to remove any out of specification product from the market.” It also notes that there “have been no known reported adverse events associated product change.”

The FDA does not state how many eye drop bottles have been recalled, but the California State Board of Pharmacy says that the recall affects three lots.

The FDA shares the following information regarding the recall:

• Product: Bromfenac Ophthalmic Solution 0.09%
• Size: 1.7 mL bottle
• Lot #: 7230309, 7230310, 7230311
• Expiration Date: 5/31/2025
• National Drug Code (NDC): 62332-508-17
• Manufacturer: Alembic Pharmaceuticals Limited, Gujarat, India
• Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921

The report suggests that India-based Alembic Pharmaceuticals Limited initiated the recall on May 7.

This week, the FDA categorized the recall as a Class II event, meaning the products have the potential to “cause temporary or medically reversible adverse health consequences.”

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