Recall for Eye Drops Distributed in 2 States

Sun Pharmaceutical Industries Inc. is recalling 35,069 bottles of Xelpros 0.005% because the product tested out of specification for particulate matter, according to the May 29, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125 mcg/2.5 mL, in 2.5-mL bottles (NDC 47335-317-90), from lot HAD3383A (Exp. 8/31/24). Sun Pharmaceutical Industries manufactured the product in India and distributed it in Texas and Pennsylvania.

Sun Pharmaceutical Industries voluntarily initiated the recall on April 22, 2024. On May 20, 2024, the FDA designated it Class III. Per the recall classification, use of the affected eye drops is not likely to cause harm.

Xelpros 0.005% is a prescription medication indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.