CLASS I Drug recall · Reported 18 Dec 2019 · FDA Enforcement Report
Mirtazapine Tablets recalled by AuroMedics Pharma
AuroMedics Pharma is recalling Mirtazapine Tablets, USP, 7, distributed nationwide in the US. The recall was initiated on 20 Nov 2019 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0637-2020
- FDA event ID
- 84336
- Recalling firm
- AuroMedics Pharma, East Windsor, NJ
- Brand
- Mirtazapine
- Manufacturer
- Aurolife Pharma LLC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 20 Nov 2019
- FDA classified
- 2 Jan 2020
- Reported
- 18 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Antidepressants
Timeline
| 20 Nov 2019 | Recall initiated by company | |
| 18 Dec 2019 | Published in enforcement report | +28 days |
| 2 Jan 2020 | Classified by FDA | +15 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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 as listed by the FDA
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 was distributed
Nationwide
Questions about this recall
Why was it 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.
Which lots are affected?
Lot #: 03119002A3, Exp 3/2022
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 84336This product is part of a recall event; the main page for the event is Mirtazapine Tablets recalled by AuroMedics Pharma.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Mirtazapine Tablets recalled by AuroMedics PharmaMirtazapine | AuroMedics Pharma | Other | Nationwide |
More recalls from AuroMedics Pharma
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fondaparinux Sodium Injection, USP, 7.5 mg per, Single Dose recalledFondaparinux Sodium | AuroMedics Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Acyclovir Sodium Injection, 500mg/ (50mg/mL) Single Dose Vial recalledAcyclovir Sodium | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS III | Tranexamic Acid Injection, USP, 1000mg recalled by AuroMedics PharmaTranexamic Acid | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS I | Polymyxin B for Injection USP per Vial vials recalledPolymyxin B | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS II | Acetaminophen Injection 1,000 mg recalled by AuroMedics PharmaAcetaminophen | AuroMedics Pharma | Other | Nationwide |
Other Mirtazapine recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mirtazapine Tablets, USP 15mg recalled by Aurobindo Pharma USAMirtazapine | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Mirtazapine Tablets recalled by AuroMedics PharmaMirtazapine | AuroMedics Pharma | Other | Nationwide |
| Drug | CLASS II | Mirtazapine Tablets, USP, 45 mg recalled by Mylan Institutional, Inc.Mirtazapine | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Other | Nationwide |
| Drug | CLASS II | Mirtazapine Tablets, USP 45 mg, a), b) and c) recalledMirtazapine | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Mirtazapine Tablet, 7.5 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |