Mirtazapine

Mirtazapine recalls: 5 FDA reports

Recalls involving Mirtazapine. What was wrong with each batch, and how the FDA graded the risk.

5Reports
2Class I
0Ongoing
2020-04-22Most recent
2 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class II3
Class I2

By year reported

YearReports
20172
20192
20201
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, N

D-1235-2020  ·  Class II  ·  reported 2020-04-22  ·  Terminated

Why it was recalled
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Product
Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34
Where it went
Nationwide within the United States
How much
56208 units
Class I

Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayto

D-0636-2020  ·  Class I  ·  reported 2019-12-18  ·  Terminated

Why it was recalled
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
Product
Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-031-05
Where it went
Nationwide
How much
N/A
Class I

Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayt

D-0637-2020  ·  Class I  ·  reported 2019-12-18  ·  Terminated

Why it was recalled
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
Product
Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-001-05
Where it went
Nationwide
How much
N/A

Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuti

D-0492-2017  ·  Class II  ·  reported 2017-03-15  ·  Terminated

Why it was recalled
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
Product
Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV
Where it went
Nationwide
How much
37,445 bottles

Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc

D-0493-2017  ·  Class II  ·  reported 2017-03-15  ·  Terminated

Why it was recalled
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
Product
Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV ---NDC 51079-088-20
Where it went
Nationwide
How much
58 UD100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each)
Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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