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Teva Pharmaceuticals Class II Recall of Metoprolol Succinate Tablets

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Filed March 11th, 2026
Detected March 28th, 2026
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Summary

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

What changed

The Food and Drug Administration (FDA) has initiated a Class II recall for Teva Pharmaceuticals USA, Inc.'s Metoprolol Succinate Extended-Release Tablets (25 mg) due to the product failing to meet dissolution specifications. This recall impacts multiple bottle sizes (100 and 1,000 tablets) distributed nationwide.

Pharmaceutical manufacturers and distributors must ensure they have identified and segregated affected product lots. Compliance with recall procedures, including notification to downstream parties and potential return or destruction of recalled product, is required. While specific compliance deadlines are not detailed, the ongoing nature of the recall necessitates prompt action to mitigate potential patient risk and regulatory non-compliance.

What to do next

  1. Identify and segregate affected Metoprolol Succinate tablet lots.
  2. Notify downstream distributors and customers of the recall.
  3. Comply with FDA recall procedures for product return or destruction.

Source document (simplified)

Teva Pharmaceuticals USA, Inc

Drug Recalls (Class II)

← All Drug Recalls (Class II) Class II D-0354-2026 · 20260311 · Ongoing

Product

Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles (NDC: 45963-709-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054

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-0354-2026

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 Recalls

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