Akorn Recalls Dozens of Ophthalmic Medications

Deviations from Current Good Manufacturing Practices have prompted Akorn Inc. to recall a multitude of prescription and over-the-counter ophthalmic products, according to the January 25, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall includes numerous antibiotics, antimicrobials, beta blockers, antihistamines, lubricants, and other eye ointments and solutions for patient use, as well as products used in practice for pupil dilation and topical anesthesia. The products were distributed throughout the United States.

Akorn voluntarily initiated the recalls October 13, 2022, and on January 13, 2023, the FDA designated them Class II. The classification communicates that use of the recalled products may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

The FDA Enforcement Report includes the comprehensive list of recalled products and their associated lot numbers.