Mirtazapine recalls

Mirtazapine products have been recalled 5 times, most recently on 22 Apr 2020. The recalling company is usually AuroMedics Pharma.

Total recalls5since 2017

Last 12 months0reported

Class I240% of total

Ongoing0latest 22 Apr 2020

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 2 40%Class II 3 60%Class III 0 0%

Why mirtazapine is recalled

Other Reasons480%
Manufacturing (CGMP) Deviations120%

Companies

Product types

Antidepressants5100%

By year

2020120%
2019240%
2017240%

All mirtazapine recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
22 Apr 2020Drug	CLASS II	Mirtazapine Tablets, USP 15mg recalled by Aurobindo Pharma USAMirtazapine	Aurobindo Pharma USA	Manufacturing (CGMP) Deviations	Nationwide
18 Dec 2019Drug	CLASS I	Mirtazapine Tablets recalled by AuroMedics PharmaMirtazapine	AuroMedics Pharma	Other	Nationwide
18 Dec 2019Drug	CLASS I	Mirtazapine Tablets recalled by AuroMedics PharmaMirtazapine	AuroMedics Pharma	Other	Nationwide
15 Mar 2017Drug	CLASS II	Mirtazapine Tablets, USP, 45 mg recalled by Mylan Institutional, Inc.Mirtazapine	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Other	Nationwide
15 Mar 2017Drug	CLASS II	Mirtazapine Tablets, USP 45 mg, a), b) and c) recalledMirtazapine	Mylan Pharmaceuticals	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.