Over 2.5 Million Bottles of Prednisolone Eye Drops Recalled Nationwide Over Foreign Substance Concern

More than 2.5 million bottles of a widely used prescription eye drop medication have been recalled nationwide after the manufacturer identified the potential presence of a foreign substance in the product, according to the U.S. Food and Drug Administration.

The recall affects Prednisolone Acetate Ophthalmic Suspension, USP, 1%, manufactured by Lupin Limited at a facility in Pithampur, India, and distributed in the United States by Lupin Pharmaceuticals Inc. According to the FDA's enforcement report, the recall covers a total of 2,530,182 bottles across three package sizes: 5-milliliter bottles with NDC 70748-332-02, 10-milliliter bottles with NDC 70748-332-03, and 15-milliliter bottles with NDC 70748-332-04. The recall, designated D-0655-2026, spans dozens of individual lot numbers with expiration dates ranging from July 2026 through March 2028.

Prednisolone acetate is a corticosteroid eye drop commonly prescribed to manage inflammation, redness, itching and swelling associated with eye infections and other inflammatory conditions. According to a description of the medication from the Mayo Clinic, prednisolone is a steroid medicine used to relieve symptoms caused by eye infections and related conditions, and it is available only with a doctor's prescription.

Lupin Pharmaceuticals initiated the voluntary recall on June 4, 2026, though the FDA did not formally classify the action as a Class II recall until June 30. Under the FDA's classification system, a Class II recall indicates that use of or exposure to the affected product may cause temporary or medically reversible adverse health consequences, a designation less severe than a Class I recall, which involves products that could cause serious harm or death, but more serious than a Class III recall, which applies to products unlikely to cause any adverse health consequences.

The recall notice does not specify additional details about the nature of the foreign substance identified in the affected bottles, and the FDA's enforcement report had not published further specifics as of the most recent update. Lupin Limited received FDA approval for its prednisolone acetate ophthalmic suspension in August 2024, and the company maintains a broad portfolio of generic pharmaceutical products, including several other ophthalmic medications. According to Optometry Advisor, the company's other recent ophthalmic-related FDA approvals include a ranibizumab biosimilar marketed as Ranluspec, a generic version of the allergy eye drop Pataday, and a generic version of the glaucoma medication Alphagan P.

Patients currently using prednisolone acetate ophthalmic suspension are advised to check the specific National Drug Code, lot number and expiration date printed on their prescription bottle against the information listed in the FDA's enforcement report to determine whether their medication is affected. Individuals who discover they have an affected bottle are encouraged to contact their prescribing ophthalmologist, optometrist, pharmacist or other healthcare provider for further guidance on how to proceed, rather than discontinuing use of the medication without professional advice, given that abruptly stopping certain steroid eye treatments can carry its own risks depending on the underlying condition being treated.

This recall comes on the heels of a separate, smaller recall affecting a different prednisolone-based eye medication. In late May, AbbVie Inc. issued a voluntary recall of its Pred Mild eye drops, a product manufactured in France, due to what the company described as failed stability specifications that could affect the drug's effectiveness and shelf life over time. That recall, classified by the FDA as a Class III action given its lower health risk profile, affected a considerably smaller batch of 2,736 bottles across two lot numbers, both with an expiration date of August 2026.

The Lupin recall adds to a broader pattern of pharmaceutical recalls the FDA has processed in recent weeks across a range of prescription medications. According to MedShadow Foundation, other recent recalls have included the heart medication Corlanor, the parathyroid disorder treatment Sensipar, the antipsychotic medication aripiprazole, the antidepressant duloxetine, the attention-deficit medication Focalin XR, the anti-seizure drug lacosamide, and nicotine transdermal patches, among others. Most of those recalls, like the prednisolone acetate action, were classified as Class II recalls, with the notable exceptions of the nicotine patch and Pred Mild recalls, both of which received the less severe Class III classification.

Nexstar's WPIX, which first reported on the recall, said it reached out to Lupin Pharmaceuticals Inc. for comment but did not receive an immediate response. As of this report, the company has not issued additional public statements detailing the specific nature of the foreign substance found in the affected bottles beyond what has been disclosed in the formal FDA recall notice.

Consumers concerned about whether their specific prescription is affected by the recall can check their bottle's National Drug Code and lot number against the FDA's publicly available enforcement report database. The agency maintains detailed listings of all active drug recalls, including the specific lot numbers, expiration dates and distribution details associated with each action, allowing patients and pharmacists to verify whether a particular bottle falls within the scope of the recall.

Given the significant scale of the recall, spanning more than 2.5 million individual bottles distributed across the country, healthcare providers have generally recommended that patients using prednisolone acetate ophthalmic suspension take a proactive approach to checking their medication rather than waiting for direct notification, since recall communications do not always reach every individual patient promptly through standard pharmacy channels. Patients who are unsure whether their eye drops are affected, or who do not have easy access to the packaging information needed to verify the lot number, are encouraged to contact the pharmacy where the prescription was filled for assistance confirming whether their specific product falls within the recall's scope.

As the recall continues to be processed through the pharmaceutical supply chain, the FDA is expected to continue monitoring the situation and may release additional details about the underlying cause of the contamination as more information becomes available from Lupin Pharmaceuticals and its manufacturing facility in India.