Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Jul 3, 2014 (12 years ago)

Metoprolol Succinate Extended-release Tablets

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol

Cause type: Particulate / foreign matter

Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.

What was recalled

Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mfg by Mylan Pharmaceuticals, Inc. Morgantown, WV 26505. NDC 0378-4596-77.

Affected NDC 0378-4596-77

Compare with the code on your package — it is the most precise check available.

Drug: Metoprolol Category: Blood Pressure Medication

Recalling firm
Mylan Pharmaceuticals Inc.
NDC code
0378-4596-77
Origin
WV, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0009-2015 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

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Other recalls by Mylan Pharmaceuticals Inc.

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Class II · Moderate risk

Prasugrel Tablets

Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria

Ongoing Dissolution failure Mylan Pharmaceuticals Inc NDC 0378-5186-93 D-0839-2026