Teva Pharmaceuticals Class II Recall of Metoprolol Succinate Tablets
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
- Identify and segregate affected Metoprolol Succinate tablet lots.
- Notify downstream distributors and customers of the recall.
- 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
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