Mirtazapine recalls

The FDA has published 7 recalls involving Mirtazapine since 2014. The latest was reported on 22 Apr 2020. Aidapak Services has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls7since 2014

Last 12 months0reported

Class I229% of total

Ongoing0latest 22 Apr 2020

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 2 29%Class II 5 71%Class III 0 0%

Why mirtazapine is recalled

Companies

Aidapak Services229%
AuroMedics Pharma229%
Mylan Pharmaceuticals114%
Aurobindo Pharma USA114%
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)114%

By year

2020114%
2019229%
2017229%
2014229%

All mirtazapine recalls, newest first

7 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
22 Jan 2014Drug	CLASS II	Mirtazapine Tablet, 7.5 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
22 Jan 2014Drug	CLASS II	Mirtazapine Tablet, 7.5 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states

Should you stop taking Mirtazapine?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.