EPI Health Issues Voluntary Recall of Several Products Following Bankruptcy

EPI Health (Novan) is initiating a voluntary recall of various within-expiry human drug products as a result of the closures and discontinuation of the post-marketing quality, regulatory and pharmacovigilance activities for these marketed products. The moves comes after EPI filed Chapter 7 bankruptcy in July 2023. In connection with that filing, the company has ceased and shutdown all operations and terminated all its employees of all domestic US Sites. 

The discontinuation of these post-marketing programs means the company will not be able to support or guarantee that the products will meet all intended specifications through the labeled shelf life of the product. Further distribution or use of any remaining product on the market should cease immediately.

EPI Health said it has not received any reports of adverse events related to this recall.

Only products and lot numbers listed below are affected by the recall. Products' lot numbers not included are owned and distributed by a new product ownership and are continuing to be monitored under a Quality Program and will remain on the market.

LIST AND LOT NUMBERS OF AFFECTED PRODUCTS