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Teva Pharmaceuticals Class II Recall: Metoprolol Succinate Tablets

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

  1. Verify inventory for affected Metoprolol Succinate Extended-Release Tablets lots.
  2. Remove recalled product from distribution channels.
  3. 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

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-0355-2026

Who this affects

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