Teva Pharmaceuticals Class II Recall: Metoprolol Succinate Tablets
Summary
The FDA has initiated a Class II recall for Teva Pharmaceuticals' Metoprolol Succinate Extended-Release Tablets due to failed dissolution specifications. The recall affects nationwide distribution and is ongoing.
What changed
The FDA has issued a Class II recall for Teva Pharmaceuticals' Metoprolol Succinate Extended-Release Tablets (50 mg, 100 and 1,000 tablet bottles) because the product failed dissolution specifications. This recall impacts distribution nationwide and is currently ongoing, identified by recall number D-0355-2026.
Drug manufacturers and distributors must ensure any affected product is removed from the market and returned according to recall procedures. Compliance officers should verify that their inventory does not contain the affected lots and implement procedures to prevent future occurrences of dissolution specification failures. While no specific compliance deadline is stated, the ongoing nature of the recall implies immediate action is required to cease distribution and manage recalled inventory.
What to do next
- Verify inventory for affected Metoprolol Succinate Extended-Release Tablets lots.
- Remove recalled product from distribution channels.
- Implement quality control measures to prevent future dissolution specification failures.
Source document (simplified)
Teva Pharmaceuticals USA, Inc
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0355-2026 · 20260311 · Ongoing
Product
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
Reason for Recall
Failed Dissolution Specifications
Distribution
Nationwide
Source: openFDA Enforcement API
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