Akorn Issues Voluntary Nationwide Recall of Various Human and Animal Drug Products Within Expiry Due to Company Shutdown

On April 26, 2023, Akorn Operating Company LLC has initiated a voluntary recall of various within-expiry human products as a result of the closures and discontinuation of the Quality activities of these marketed products. The discontinuation of the Quality program would result in the company's inability to assure that products meet the identity, strength, quality, and purity characteristics. While specific risks to patients cannot always be identified or assessed, there is still a potential risk from using the products. Akorn has not received any reports of adverse events related to this recall.

If you have any of the recalled products, you should discard the product and contact your doctor. You should contact your physician or healthcare provider if you have any questions or concerns.

For questions regarding this recall can contact Akorn at (800) 932-5676, Monday – Friday, 8am – 5pm CDT.

Source:

1. FDA MedWatch. “Recalls, Market Withdrawals, & Safety Alerts”. Retrieved May 1, 2023 from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/akorn-issues-voluntary-nationwide-recall-various-human-and-animal-drug-products-within-expiry-due?utm_medium=email&utm_source=govdelivery