Teva Pharmaceuticals USA, Inc. - Metoprolol Succinate Recall
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
- Identify and quarantine affected Metoprolol Succinate Extended-Release Tablets, 200 mg, lot numbers.
- Cease distribution of recalled product.
- 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
Related changes
Source
Classification
Who this affects
Taxonomy
Browse Categories
Get Pharma & Drug Safety alerts
Weekly digest. AI-summarized, no noise.
Free. Unsubscribe anytime.
Get alerts for this source
We'll email you when FDA: Drug Recalls Class II publishes new changes.