CLASS II Drug recall · Reported 15 Oct 2014 · FDA Enforcement Report

Metoprolol Succinate Extended-release Tablets, USP 50mg recalled

Mylan Pharmaceuticals is recalling Metoprolol Succinate Extended-release Tablets, USP 50mg, distributed nationwide in the US. The recall was initiated on 3 Jul 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 3023805 Exp. 11/15

Quantity recalled15,966 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0009-2015
FDA event ID: 68783
Recalling firm: Mylan Pharmaceuticals, Morgantown, WV
Classification: Class II
Status: Terminated
Recall initiated: 3 Jul 2014
FDA classified: 8 Oct 2014
Reported: 15 Oct 2014
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Drug class: Blood Pressure Medication

Timeline

3 Jul 2014	Recall initiated by company
8 Oct 2014	Classified by FDA	+97 days
15 Oct 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot 3023805 Exp. 11/15

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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20 May 2026Drug	CLASS II	Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* recalled	Ascend Laboratories	Potency & Assay	Nationwide
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11 Mar 2026Drug	CLASS II	Metoprolol Succinate Extended-Release Tablets, 200 mg recalledMetoprolol Succinate	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
11 Mar 2026Drug	CLASS II	Metoprolol Succinate Extended-Release Tablets, 25 mg bottles recalledMetoprolol Succinate	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
11 Mar 2026Drug	CLASS II	Metoprolol Succinate Extended-Release Tablets, 50 mg bottles recalledMetoprolol Succinate	Teva Pharmaceuticals USA	Potency & Assay	Nationwide