Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts
Class II · Moderate risk Ongoing Initiated Jan 29, 2026 (8 months ago)

Metoprolol Succinate Extended-Release Tablets

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Failed Dissolution Specifications

Cause type: Dissolution failure

The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.

What was recalled

Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054, NDC: 45963-678-11

Affected NDC 45963-0678-11

Compare with the code on your package — it is the most precise check available.

Drug: Metoprolol Category: Blood Pressure Medication

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

ProductStrengthForm & routeLabelerType
metoprolol succinate
NDC 45963-0678
200 mg/1 Tablet, Film Coated, Extended Release Actavis Pharma, Inc. DRUG FOR FURTHER PROCESSING
Recalling firm
Teva Pharmaceuticals USA, Inc
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0357-2026 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.

Other Metoprolol recalls

See all
Class II · Moderate risk

Metoprolol Tartrate Tablets

CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.

Ongoing Nitrosamine impurity Westminster Pharmaceuticals LLC NDC 69367-355-10 D-0582-2025

Other recalls by Teva Pharmaceuticals USA, Inc

All 2026 recalls