Eye Solution Recalled

Akorn Inc is recalling 10,210 bottles of betaxolol ophthalmic solution after 12-month stability testing identified microbial contamination, according to the October 13, 2021, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects betaxolol ophthalmic solution 0.5% (betaxolol hydrochloride 5.6 mg/mL) in 5-mL dropper bottles (bottle NDC 17478-705-11, carton NDC 17478-705-10) from lot 0B61A (Exp. 1/31/22). The product was manufactured by Akorn Inc, Lake Forest, IL, and distributed throughout the United States.  

Akorn voluntarily initiated the recall October 4, 2021. On October 7, 2021, the FDA designated the recall Class II, communicating use of the solution may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Betaxolol ophthalmic solution is available with a prescription to treat ocular hypertension and chronic open-angle glaucoma.