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Lower risk Drug recall · FDA · Published January 19, 2017

Mirtazapine 45mg Tablets Recall: Foreign Glipizide Risk

Mylan recalls 45mg mirtazapine tablets (30, 100, 500 count) due to possible glipizide tablets contaminating the bottles. Affected products were sold with specific NDC numbers and expiration dates.

🇺🇸 FDA recall #D-0492-2017DrugMylan Pharmaceuticals ›
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Recalling firmMylan Pharmaceuticals Inc.781 Chestnut Ridge Rd · Morgantown, WV 26505-2730
✎ GovInfoNow plain-language explainer

What happened, in plain English

Mylan is recalling 45mg mirtazapine tablets in 30-count, 100-count, and 500-count bottles because some bottles may contain foreign glipizide tablets. This could lead to unintended medication intake if the contaminated tablets are taken. Read more at govinfonow.com/recall/42072-mirtazapine-45mg-tablets-recall-foreign-glipizide-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/42072-mirtazapine-45mg-tablets-recall-foreign-glipizide-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0492-2017

Cite this page

“Mirtazapine 45mg Tablets Recall: Foreign Glipizide Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42072-mirtazapine-45mg-tablets-recall-foreign-glipizide-risk. Based on FDA recall #D-0492-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0492-2017%22&limit=1).

Why it’s dangerous

The recall is for mirtazapine tablets that may contain foreign glipizide tablets. Glipizide is a different diabetes medication that could cause unintended side effects if taken by someone who should not be taking it. However, the risk is low because the foreign tablets are not expected to be present in all bottles.

Who’s affected

Prescription medication users who have the specific 45mg mirtazapine tablets with NDC numbers 0378-3545-93, 0378-3545-01, or 0378-3545-05. People most at risk are those who take the medication as prescribed without checking the bottle contents.

How to tell if you have this one

Check for the NDC numbers 0378-3545-93, 0378-3545-01, or 0378-3545-05 on the bottle. The products were sold with expiration dates of August 2019.

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

What to do — step by step

  1. Check Bottle Contents

    Inspect the bottle for any foreign tablets that might be present.

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 6 months after the firm started it.

1. Firm started the recall: Jan 19, 201712. FDA classified it Class II: Mar 8, 201723. Published in FDA’s Enforcement Report: Mar 15, 201734. FDA terminated the recall: Jul 12, 201742017
  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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Questions people ask

What should I do if I have the recalled product?

Check the bottle for foreign tablets. If you find any, stop using the product and contact your doctor or pharmacist.

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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-0492-2017 (January 19, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0492-2017 to see it in context.
  • Plain-language summary written by qwen3:4b on October 8, 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