Teva Pharmaceuticals Recalls Metoprolol Succinate Extended-Release Tablets Due to Dissolution Failure

Source: FDA · United States

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Teva Pharmaceuticals USA, Inc. has voluntarily recalled over 67,000 bottles of Metoprolol Succinate Extended-Release Tablets after the medication failed dissolution specifications.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 2, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

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What Happened

Teva Pharmaceuticals USA, Inc. has initiated a voluntary Class II recall of Metoprolol Succinate Extended-Release Tablets, 50 mg. The recall was triggered after the product failed to meet dissolution specifications during testing. This failure indicates the medication may not release the active ingredient at the required rate.

Which Products Are Affected

The recall affects 67,043 bottles distributed nationwide across the United States. The specific products include:

  • Product Name: Metoprolol Succinate Extended-Release Tablets, 50 mg
  • Packaging: 100-tablet bottles (NDC: 45963-676-11) and 1,000-tablet bottles (NDC: 45963-676-96)
  • Lot Numbers: 0486G251, 0487G251, 0488G251, 0486G252, 0487G253, and 0488G252
  • Expiration Date: 01/2027
  • Manufacturer: Actavis Pharma, Inc.

What You Should Do

Consumers who possess the affected lots should contact their healthcare provider or pharmacist to discuss alternative treatments. The firm initiated the recall process by sending notification letters to distributors and customers on January 29, 2026. For further inquiries, the recalling firm, Teva Pharmaceuticals USA, Inc., is located at 400 Interpace Pkwy Bldg A, Parsippany, NJ 07054.

Why This Matters

When an extended-release medication fails dissolution specifications, it may not provide the intended therapeutic effect or could potentially release the drug too quickly, which is a significant concern for patients managing cardiovascular conditions.

Source

Information provided by the FDA under Recall Number D-0355-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Teva Pharmaceuticals USA, Inc. has voluntarily recalled over 67,000 bottles of Metoprolol Succinate Extended-Release Tablets after the medication failed dissolution specifications.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.