FDA Recalls Over 2.5 Million Bottles of Prednisolone Acetate Eye Drops for Foreign Substance Contamination

The Food and Drug Administration has ordered a nationwide recall of more than 2.5 million bottles of prednisolone acetate eye drops due to contamination with a foreign substance. The affected medication, produced by Lupin Limited, treats allergies and eye inflammation, with the recall classified as Class II, meaning users may experience temporary, reversible health effects.

Scope and Identification of Affected Products

The recall encompasses prednisolone acetate ophthalmic suspension at 1% strength, distributed in 5-milliliter, 10-milliliter, and 15-milliliter bottles. The FDA initially reported concerns regarding Lupin Limited's manufacturing practices in early June, then elevated the recall to Class II status at the end of June. Affected bottles carry multiple lot codes spanning from mid-2026 through late 2027 expiration dates, with the earliest affected batches set to expire in July 2026 and the latest in December 2027.

Patients using this medication should verify their prescriptions against the complete list of affected lot codes, which include designations such as HA00937, HA00939, HA00941, HA00971, HA00973, and HA00975 for the initial batch, followed by dozens of additional lot numbers extending through HC00058. The geographic scope remains nationwide, affecting patients across all United States regions who received prednisolone acetate from this manufacturer.

What Patients Should Do

Consumers who possess any of the recalled eye drops should discontinue use immediately and consult their healthcare provider regarding alternative medications. The FDA recommends checking prescription labels for the national drug codes and lot numbers listed in the official recall notice. Patients requiring continued treatment for eye allergies or inflammation should discuss replacement options with their ophthalmologist or pharmacist, as other manufacturers produce similar formulations that remain available.