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Teva Pharmaceuticals USA, Inc. - Metoprolol Succinate Recall

Favicon for changeflow.com FDA: Drug Recalls Class II
Filed March 11th, 2026
Detected March 28th, 2026
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Summary

The FDA has initiated a Class II recall for Teva Pharmaceuticals USA, Inc.'s Metoprolol Succinate Extended-Release Tablets (200 mg) due to failed dissolution specifications. The recall is nationwide and affects approximately 100-count bottles.

What changed

The FDA has issued a Class II recall for Teva Pharmaceuticals USA, Inc.'s Metoprolol Succinate Extended-Release Tablets, 200 mg, nationwide. The reason for the recall is that the drug failed to meet dissolution specifications, indicating a potential issue with its efficacy or performance. This recall impacts Teva Pharmaceuticals and its distribution network.

Pharmaceutical manufacturers and distributors must ensure they have identified and quarantined affected product lots. Compliance officers should verify that all product distributed nationwide has been accounted for and removed from shelves. While specific compliance deadlines are not detailed, prompt action is expected to mitigate patient risk and comply with FDA recall procedures.

What to do next

  1. Identify and quarantine affected Metoprolol Succinate Extended-Release Tablets, 200 mg, lot numbers.
  2. Cease distribution of recalled product.
  3. Report recall status and actions taken to the FDA.

Source document (simplified)

Teva Pharmaceuticals USA, Inc

Drug Recalls (Class II)

← All Drug Recalls (Class II) Class II D-0357-2026 · 20260311 · Ongoing

Product

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

Reason for Recall

Failed Dissolution Specifications

Distribution

Nationwide

Source: openFDA Enforcement API

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
FDA
Filed
March 11th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
D-0357-2026

Who this affects

Applies to
Drug manufacturers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug Recalls
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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