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Teva Pharmaceuticals Class II Drug Recall - Metoprolol Succinate

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Summary

The FDA has initiated a Class II drug recall for Teva Pharmaceuticals' Metoprolol Succinate Extended-Release Tablets due to failed dissolution specifications. The recall affects product distributed nationwide and is ongoing.

What changed

The Food and Drug Administration (FDA) has issued a Class II drug recall for Teva Pharmaceuticals USA, Inc.'s Metoprolol Succinate Extended-Release Tablets (100 mg). The recall, identified by docket number D-0356-2026, is due to the product failing to meet dissolution specifications. This recall impacts product distributed nationwide.

Pharmaceutical manufacturers and distributors must immediately identify and quarantine affected Metoprolol Succinate Extended-Release Tablets. Companies should follow their established recall procedures and coordinate with Teva Pharmaceuticals and the FDA regarding the disposition of recalled product. Failure to comply with recall procedures can result in regulatory action.

What to do next

  1. Identify and quarantine affected Metoprolol Succinate Extended-Release Tablets.
  2. Follow established recall procedures for product disposition.
  3. Coordinate with Teva Pharmaceuticals and the FDA on recall execution.

Archived snapshot

Mar 28, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Teva Pharmaceuticals USA, Inc

Drug Recalls (Class II)

← All Drug Recalls (Class II) Class II D-0356-2026 · 20260311 · Ongoing

Product

Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054.

Reason for Recall

Failed Dissolution Specifications

Distribution

Nationwide

Source: openFDA Enforcement API

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Last updated

Classification

Agency
FDA
Filed
March 11th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
D-0356-2026
Docket
D-0356-2026

Who this affects

Applies to
Drug manufacturers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug Recalls Product Quality
Threshold
Class II recall
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Compliance frameworks
FDA 21 CFR Part 11 GxP
Topics
Product Safety Drug Manufacturing

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