Teva Metoprolol Succinate Tablets Recalled for Failed Dissolution Specifications
The US Food and Drug Administration (FDA) has classified a Class II recall for multiple strengths of Metoprolol Succinate Extended-Release Tablets manufactured and distributed by Teva Pharmaceuticals USA, Inc., Parsippany, NJ. The recall affects 25 mg, 50 mg, 100 mg, and 200 mg strengths packaged in 100-count and 1000-count bottles, totaling 112 327 bottles distributed nationwide. Impacted lots carry expiration dates ranging from December 2026 through February 2027, including:
- 25 mg (NDC 45963-709-11; 45963-709-96) – Lots 0715J251, 0716J251, 0717J251; 0715J252, 0716J252, 0717J252
- 50 mg (NDC 45963-676-11; 45963-676-96) – Lots 0486G251, 0487G251, 0488G251; 0486G252, 0487G253, 0488G252
- 100 mg (NDC 45963-677-11; 45963-677-96) – Lots 0718J251, 0729J251, 0730J251; 0718J252, 0729J252, 0730J252
- 200 mg (NDC 45963-678-11) – Lots 0686H251, 0687H251, 10688H251
The recall was voluntarily initiated on January 29, 2026.
The recall was prompted by failed dissolution specifications, meaning certain lots did not meet required drug release parameters during quality testing. The FDA designated the action as Class II on February 27, 2026, indicating that use of the affected product may cause temporary or medically reversible adverse health consequences, though serious harm is unlikely. Dissolution failure in extended-release formulations may lead to inconsistent drug release and variable therapeutic response. Teva notified consignees by letter; no public press release has been issued.
Metoprolol succinate extended-release is a beta-1 selective beta-blocker indicated for the treatment of hypertension, angina pectoris, and heart failure, and for reducing cardiovascular risk in certain patient populations. Because it is an extended-release formulation, proper dissolution is critical to ensure consistent 24-hour beta-blockade. Pharmacists should review inventory for the affected lot numbers, quarantine impacted stock, and coordinate replacement supply to prevent interruption in cardiovascular therapy. Patients should not discontinue beta-blocker therapy abruptly without clinical guidance.
Reference
FDA. Enforcement Report. March 11, 2026. Accessed March 12, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm
