Bausch and Lomb, part of Valeant Pharmaceuticals, has issued a Class III voluntary recall of more than 1 million bottles of tropicamide ophthalmic solution due to a labeling and packaging error: the package insert is missing updates compared with the reference drug insert.

The Class III recall was initiated on January 18, 2016 and applies to products distributed in the United States, including Puerto Rico. A Class III recall is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Tropicamide is used to dilate the pupil before eye examinations, such as cycloplegic refraction and examination of the fundus of the eye, and may also be used before and after eye surgery.

The recall applies to various lots and strengths. The recall applies to: 416,441 bottles of tropicamide ophthalmic solution USP, 1%, packaged in 2-mL bottles; 674,177 bottles of tropicamide ophthalmic solution USP, 1%, packaged in 15-mL bottles; and 119,393 bottles of tropicamide ophthalmic solution USP, 0.5%, packaged in 15-mL bottles.

Source: US Food and Drug Administration (first notice) and US Food and Drug Administration (second notice)