The US Food and Drug Administration (FDA) has recalled 2,530,182 bottles of eye drops nationwide from India-based Lupin Limited due to the presence of a foreign substance. Lupin initiated the ongoing recall of the eye drops and the FDA posted the recall initiation date on June 4 with a center classification date of June 30.

The eye drops affected in the recall include prednisolone acetate ophthalmic suspension, USP, 1%, Rx only, sterile in 5 mL (NDC 70748-332-02), 10 mL (NDC 70748-332-03), and 15 mL (70748-332-04) bottles. For specific lot numbers and expiration dates click here.  

The recall is classified as a Class II recall. According to the FDA, a Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

According to Lupin, prednisolone acetate ophthalmic suspension is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. RP