Beta-Blocker Tablets Recalled

Two firms are recalling metoprolol succinate extended-release tablets for failing to meet dissolution specifications, according to the February 2, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recalls affect the following products, which were manufactured by Alkem Laboratories Ltd, Mumbai, India:

• 25-mg metoprolol succinate extended-release tablets in 100-count bottles (NDC 67877-590-01), from lot 21143093 (Exp. 3/23). The tablets were distributed by the recalling firm Ascend Laboratories, Parsippany, NJ, throughout the United States.
• 50-mg metoprolol succinate extended-release tablets in 500-count bottles (NDC 68001-501-03) from lots 21141983 (Exp. 3/31/23), 21141984 (Exp. 3/31/23), 21141985 (Exp. 3/31/23), 21142017 (Exp. 2/28/23), 21142018 (Exp. 2/28/23), and 21142019 (Exp. 2/28/23). The product was recalled by American Health Packaging and was distributed throughout the United States.

American Health Packaging initiated its recall December 20, 2021, and Ascend Laboratories followed on January 12, 2022. The FDA designated both voluntary recalls Class II in January 2022. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Metoprolol succinate is a prescription beta-blocker used to treat chest pain, heart failure, and high blood pressure.