Eye drops are related to one of the body’s most sensitive areas, making any possible product contamination especially concerning.However, the latest eye-drop recall differs from many of the warnings consumers may remember involving over-the-counter artificial tears.This recall affects a prescription corticosteroid commonly used after eye surgery or to treat inflammatory eye conditions.Lupin Pharmaceuticals is voluntarily recalling more than 2.5 million bottles of Prednisolone Acetate Ophthalmic Suspension, USP, 1%.The recall is because of the “presence of foreign substance,” according to a U.S. Food and Drug Administration enforcement report.The FDA report did not identify the substance or provide additional information about how it was discovered in the public recall record.The company initiated the nationwide recall in June, and the FDA classified it as a Class II recall on June 30. The recall remains ongoing.Eye drop recall covers three bottle sizesThe recall covers 2,530,182 bottles manufactured by Lupin Limited at its Pithampur, India, facility.The affected prescription eye drops were sold in three sizes:5-milliliter bottles with NDC 70748-332-0210-milliliter bottles with NDC 70748-332-0315-milliliter bottles with NDC 70748-332-04Numerous lots are included, with expiration dates ranging from July 31, 2026, through March 31, 2028.More Recalls:FDA recall raises concern over blood pressure drugHonda’s million-vehicle recall hits core SUVs and trucksJeep owners should take immediate action to avoid huge riskBecause the recall involves roughly 190 separate lots, consumers should not assume a bottle is affected solely by its product name or appearance. Patients need to compare the NDC, lot number, bottle size, and expiration date with the FDA’s complete recall list.The FDA has classified the action as Class II, its second-highest recall category.A Class II designation means using the product could cause temporary or medically reversible health consequences, while the probability of serious health consequences is considered remote.That does not mean every bottle is contaminated or that everyone who used the medication will experience a health problem. It signals that the product does not meet the required standards and is being removed from distribution.
The FDA recalls 2.5 million bottles of eye drops.SelectStock / Getty Images
Patients should check the lot before changing treatmentPrednisolone acetate is a topical corticosteroid used to control inflammation affecting the conjunctiva, cornea, and other parts of the eye.It is also routinely prescribed following procedures such as cataract surgery. Some patients use it several times daily for weeks or months, while people recovering from certain procedures, including corneal transplants, may require longer treatment.UC Davis ophthalmologist Jeffrey Ma described it as “one of the most widely prescribed topical corticosteroid eye drops.”“It is commonly used to treat inflammatory eye conditions, such as iritis and uveitis, which are a group of diseases that cause inflammation of the iris and other surrounding structures inside the eye,” added Ma.Patients whose bottles appear on the recall list should contact their prescribing physician or pharmacist immediately to arrange a replacement, according to UC Davis Health.Prednisolone products that are not made by Lupin or whose lot numbers are not included in the recall are not part of this action. No adverse events connected to the current Lupin recall had been reported as of July 13.Related: 44-year-old mall retailer quietly closes 28 stores