The FDA has announced a nationwide recall of over 13,000 bottles of Dr. Reddy’s Laboratories‘ Metoprolol Succinate Extended-Release Tablets, the generic version of AstraZeneca’s Toprol XL. The recall was prompted due to failure of dissolution test observed at the 18 month time point. This major recall of generic Metoprolol follows Wockhardt’s announcement from May 2014.
The recall affects the 25mg tablets in 100-count bottles manufactured at the Dr. Reddy’s facility in India. The affected lots contain Lot # C206578 with Exp. 05/14 and Lot # C207415 with Exp. 06/14.
This recall is categorized as Class II where it “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Metoprolol Succinate is a beta-blocker indicated for the treatment of stable, symptomatic (NYHA Class II or III) ischemic, hypertensive, or cardiomyopathic heart failure; hypertension; and the long-term treatment of angina.
For more information visit FDA.gov.