The U.S. Food and Drug Administration (FDA) has upgraded the recall of more than 2.5 million bottles of eye drops, citing concerns that the product may contain a foreign substance and pose a risk of adverse health consequences.
Florida-based Lupin Pharmaceutical initiated a voluntary recall last month of its prescription-only prednisoLONE Acetate Ophthalmic Suspension, 1%, due to the detection of an unspecified foreign substance. The nationwide alert covers eye drops sold in white plastic bottles with pink caps, in 5, 10, or 15 milliliter sizes.
Initially, the FDA had not classified the threat level. However, the agency recently upgraded the recall to a Class II designation. This classification signifies a situation where the use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
No illnesses or deaths have been reported in connection with these eye drops to date, according to the FDA. While specific guidance for consumers has not been issued, previous recalls of similar products have advised patients to consult their healthcare provider before discontinuing any prescription medication.
Prednisolone eye drops are prescribed in the U.S. to manage eye conditions such as allergies, injuries, or inflammation, helping to alleviate symptoms like swelling, redness, and itching. The steroid medication is also available in other forms, including inhalers for allergies, tablets for autoimmune conditions, and injections for joint pain.
Last year, over 3.8 million prescriptions for prednisolone eye drops were written in the United States. A comprehensive list of the recalled lot codes is available on the FDA's website.
The eye drops were manufactured in Pithampur, India. The method by which the contamination was detected and the exact nature of the foreign substance remain unclear. Historically, eye drop recalls have occurred due to contamination with bacteria, fungi, or glass particles, which can enter the products during manufacturing.
This recall follows significant previous incidents. In 2023, a large-scale recall involved eye drops made in India found to be contaminated with a multidrug-resistant bacterium, Pseudomonas aeruginosa. That contamination led to 81 patient illnesses, 18 cases of permanent blindness, and four deaths. Earlier this year, in April, over 3 million eye drops were recalled from K.C. Pharmaceuticals, based in California, due to a lack of assurance over sterility, also resulting in a Class II recall.