On September 29, 2023, KVK-Tech announced a voluntary recall of betaxolol 10 mg tablets as a precautionary measure. A single oxycodone 5 mg foreign tablet was found on the packaging line after the recalled batch was packaged. It is unknown if any oxycodone tablets were introduced into any of the affected bottles of betaxolol. There are only minor differences in appearance between betaxolol 10 mg tablets and oxycodone 5 mg tablets, and patients may not notice these differences if they are contained in the same bottle. Inadvertent exposure to an opioid such as oxycodone can lead to significantly slowed breathing and heart rate, especially in older adults, infants, children and persons with opioid use disorder (OUD). Missed doses of betaxolol could worsen heart and lung function. Betaxolol 10 mg tablets are white, round, film-coated biconvex tablets, debossed with a “K” above the bisect scoring line and “13” below the line and are plain on the other side.
The recalled lot has an associated lot number of 17853A and expiration date of June 2027. It was distributed nationwide to wholesalers and retailers. KVK sent letters to distributors and customers on 09/26/23, and they are arranging for the return of the recalled lot. Additionally, consumers with bottles of the recalled lot should stop using and immediately return the product. To date, there have been no reports of adverse events associated with this recall. Patients experiencing any adverse events related to the product are advised to contact their physician or health care provider and to report the event to the FDA’s MedWatch Adverse Event Reporting Program.