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Lower risk Drug recall · FDA · Published January 27, 2017

Mylan Mirtazapine 45mg Tablets Recall: Foreign Glipizide Risk

Mylan recalls 45mg Mirtazapine tablets (NDC 51079-088-20) due to possible glipizide tablets being mixed in. This could cause unintended medication intake. Check your prescription label for batch #3083289.

🇺🇸 FDA recall #D-0493-2017DrugMylan ›
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Recalling firmMylan Institutional, Inc. (d.b.a. UDL Laboratories)1718 Northrock Ct · Rockford, IL 61103-1201
✎ GovInfoNow plain-language explainer

What happened, in plain English

Mylan is recalling 45mg Mirtazapine tablets that may contain glipizide tablets. This could lead to taking the wrong medication, which might cause health issues. Affected patients should check their prescription labels for the specific batch number. Read more at govinfonow.com/recall/42070-mylan-mirtazapine-45mg-tablets-recall-foreign-glipizide-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/42070-mylan-mirtazapine-45mg-tablets-recall-foreign-glipizide-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0493-2017

Cite this page

“Mylan Mirtazapine 45mg Tablets Recall: Foreign Glipizide Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42070-mylan-mirtazapine-45mg-tablets-recall-foreign-glipizide-risk. Based on FDA recall #D-0493-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0493-2017%22&limit=1).

Why it’s dangerous

The recall is for tablets that might have glipizide tablets mixed in. Glipizide is a different medication that could be taken by mistake, leading to unintended effects.

Who’s affected

Patients prescribed Mirtazapine 45mg tablets by a doctor. Those who have the specific batch number (3083289) are most at risk.

How to tell if you have this one

Check your prescription label for the batch number 3083289. The product is a 45mg Mirtazapine tablet (100 tablets, 10 x 10) with NDC 51079-088-20.

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

What to do — step by step

  1. Check Your Prescription Label

    Look for the batch number 3083289 on the prescription label for the Mirtazapine tablets.

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 2.1 years after the firm started it.

1. Firm started the recall: Jan 27, 201712. FDA classified it Class II: Mar 8, 201723. Published in FDA’s Enforcement Report: Mar 15, 201734. FDA terminated the recall: Mar 15, 2019420172019
  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-0493-2017 (January 27, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0493-2017 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