Class II · Moderate risk
Ascend Laboratories
Failed Dissolution Specifications
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, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles (NDC: 45963-676-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054
Affected NDCs
45963-0676-11
45963-0676-96
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.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| metoprolol succinate NDC 45963-0676 |
50 mg/1 | Tablet, Film Coated, Extended Release Oral |
Actavis Pharma, Inc. | Rx |
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0355-2026 · 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 Succinate Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Metoprolol Tartrate Tablets
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Other recalls by Teva Pharmaceuticals USA, Inc
All 2026 recalls
Class II · Moderate risk
traZODone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Octreotide Acetate for Injectable Suspension
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk
Claravis (isotretinoin capsule, USP)
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
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