Pfizer has issued a Class II voluntary recall of specific lots of Lyrica (pregabalin) capsules due to the potential presence of deformed or damaged capsules. The recall was initiated on January 11, 2016 for the United States, including Puerto Rico. The recall notice was noted in the US Food and Drug Administration’s Weekly Enforcement Report of February 10, 2016.

A Class II recall 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.

The recall applies to 116,400 bottles of Lyrica (pregabalin) capsules, 75 mg, 90-count bottle, prescription only and distributed by: Parke-Davis, a division of Pfizer, and 30,672 bottles of Lyrica (pregabalin) capsules, 50 mg, 90-count bottle, prescription only, distributed by: Parke-Davis.

Lyrica is indicated in the US for three neuropathic pain conditions, fibromyalgia, and as an adjunctive therapy for adult patients with partial onset seizures.

Source: FDA (116,400 bottles) and FDA (30,672 bottles)