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Use caution Drug recall · FDA · Published July 3, 2014

Mylan Recalls Metoprolol Succinate Due to Foreign Tablet Risk

Mylan recalls 15,966 bottles of Metoprolol Succinate 50mg tablets due to the presence of a foreign tablet. Check your lot number and expiration date.

🇺🇸 FDA recall #D-0009-2015DrugMylan Pharmaceuticals ›
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Recalling firmMylan Pharmaceuticals Inc.781 Chestnut Ridge Rd · Morgantown, WV 26505-2730
✎ GovInfoNow plain-language explainer

Mylan Pharmaceuticals Inc. is recalling specific bottles of Metoprolol Succinate Extended-release Tablets, USP 50mg because a pharmacist found a rogue tablet of different size and markings inside one bottle. This recall affects 15,966 bottles distributed nationwide. The record does not specify the remedy or what consumers should do with the product. Read more at govinfonow.com/recall/45964-mylan-pharmaceuticals-inc-recalls-metoprolol-succinate-extended-release-tablets-usp.

Source Summary by GovInfoNow · govinfonow.com/recall/45964-mylan-pharmaceuticals-inc-recalls-metoprolol-succinate-extended-release-tablets-usp · Updated October 12, 2026 · FDA enforcement record: FDA #D-0009-2015

Cite this page

“Mylan Recalls Metoprolol Succinate Due to Foreign Tablet Risk.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/45964-mylan-pharmaceuticals-inc-recalls-metoprolol-succinate-extended-release-tablets-usp. Based on FDA recall #D-0009-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0009-2015%22&limit=1).

Mylan Pharmaceuticals Inc. voluntarily recalled Metoprolol Succinate Extended-release Tablets due to foreign tablet contamination, according to the FDA. The Food and Drug Administration announced the Class II recall on July 3, 2014.

How to tell if you have it

  • Brand: Mylan Pharmaceuticals
  • Product: Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles
  • NDC: 0378-4596-77
  • Lot Code: 3023805
  • Expiration Date: 11/15
  • Quantity: 15,966 bottles

The hazard

A pharmacist reported a rogue tablet of different size and markings in a bottle of Metoprolol. The FDA classified the recall as Class II.

Context

GovInfoNow's records show Mylan Pharmaceuticals Inc. has 54 other recalls on record since June 28, 2012. Recent brand recalls include Mycophenolate Mofetil Injections on Aug. 26, 2026, and Prasugrel Tablets on Aug. 17, 2026. Other recent recalls of similar products include Teva Metoprolol Succinate Tablets (Jan. 29, 2026), Golden State Medical Primidone Tablets (April 27, 2026), and Bionpharma Divalproex Tablets (June 26, 2026).

How to tell if you have this one

Look for Metoprolol Succinate Extended-release Tablets, USP 50mg in 90-count bottles manufactured by Mylan Pharmaceuticals Inc. in Morgantown, WV. Specifically check for NDC 0378-4596-77 and Lot number 3023805 with an expiration date of 11/15.

  • Brand
    Mylan Pharmaceuticals
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Your Medication

    Verify if your bottle matches NDC 0378-4596-77 and Lot 3023805 with expiration date 11/15.

  2. Contact Your Pharmacist

    Since the remedy is not stated in the record, consult your pharmacist or healthcare provider for instructions on how to proceed.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

1. Firm started the recall: Jul 3, 201412. FDA classified it Class II: Oct 8, 201423. Published in FDA’s Enforcement Report: Oct 15, 201434. FDA terminated the recall: Sep 20, 2016420142016
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0009-2015 (July 3, 2014) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0009-2015 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 12, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA