More than 2 million bottles of a commonly prescribed steroid eye drop are part of a U.S. recall, but patients should not panic or decide on their own to stop treatment.
What happened?
The product involved is prednisolone acetate ophthalmic suspension, USP, 1%, a prescription steroid eye drop used to reduce inflammation.
In total, more than two-and-a-half million bottles of the product are affected by the recall, which began at the end of June after concerns about possible foreign material in the product, according to the Food and Drug Administration.
On June 30, the Food and Drug Administration labeled the recall as Class II, the agency's second-highest risk category. Under that designation, serious health effects are not expected, but temporary or reversible problems can still occur.
The FDA also noted that the recall was voluntary and initiated by the firm itself, Lupin Pharmaceuticals Inc.
If you want more information about the product or the recall, use this recall number: D-0655-2026.
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Why does it matter?
Because prednisolone eye drops are often used after eye surgery and for inflammatory eye conditions, the recall matters beyond simple inconvenience.
These medications are meant to control swelling, irritation, itching, and even allergic reactions, so stopping them too abruptly can create problems of its own.
Jennifer Young, lead medication safety specialist at the Institute for Safe Medication Practices, previously told Health, "While recall notifications can be frightening, it's important to contact your healthcare provider right away for advice before making any changes to your medication routine."
Young added that "some medications … should not be stopped suddenly."
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What can I do?
The first step is to confirm exactly what bottle you have. If you use prednisolone acetate ophthalmic suspension, compare the bottle size, NDC number, lot code, and expiration date on your label with the FDA recall notice.
If your bottle matches the affected product, do not stop using it before getting guidance from a medical professional. Call your pharmacist, prescribing doctor, or another healthcare provider first, since you may need either a replacement prescription or a tapering plan instead of an abrupt stop.
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