AuroMedics Pharma LLC recalls Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ
AuroMedics Pharma LLC recalls 500-count Mirtazapine 15mg tablets labeled as 7.5mg due to a labeling error. This could lead to incorrect dosing if used without proper medical guidance.
Lower-risk 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.
Contact the company & request your remedy
What happened, in plain English
AuroMedics Pharma LLC is recalling 500-count Mirtazapine 15mg tablets that were incorrectly labeled as 7.5mg. This labeling error could cause patients to take the wrong dose if they rely on the label for dosing instructions. Read more at govinfonow.com/recall/37683-auromedics-mirtazapine-15mg-tablets-recalled-due-to-labeling-error.
Source Summary by GovInfoNow · govinfonow.com/recall/37683-auromedics-mirtazapine-15mg-tablets-recalled-due-to-labeling-error · Updated October 5, 2026 · FDA enforcement record: FDA #D-0636-2020
Cite this page
“AuroMedics Mirtazapine 15mg Tablets Recalled Due to Labeling Error.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37683-auromedics-mirtazapine-15mg-tablets-recalled-due-to-labeling-error. Based on FDA recall #D-0636-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0636-2020%22&limit=1).
Why it’s dangerous
The tablets are labeled as 7.5mg but contain 15mg. If patients take the tablets based on the label, they could receive double the intended dose, leading to potential side effects. This error occurs because the labeling was incorrect during manufacturing.
Who’s affected
Prescription patients who have the 500-count Mirtazapine 15mg tablets labeled as 7.5mg. Those who use the medication without medical supervision are at higher risk of incorrect dosing.
How to tell if you have this one
Check for 500-count bottles of Mirtazapine tablets labeled as 7.5mg but containing 15mg. The product was distributed by Aurobindo Pharma USA, Inc. in Dayton, NJ with NDC 13107-031-05 and lot number 03119002A3.
- Brand
AuroMedics- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Terminated- Distribution
Nationwide- NDC
13107-001-30, 13107-001-60, 13107-001-90, 13107-001-01, 13107-001-05, 13107-031-30, 13107-031-34, 13107-031-60, 13107-031-90, 13107-031-01, 13107-031-05, 13107-031-32, 13107-003-30, 13107-003-34, 13107-003-60, 13107-003-90, 13107-003-01, 13107-003-05, 13107-003-32, 13107-032-34, 13107-032-60, 13107-032-90, 13107-032-01, 13107-032-05, 13107-032-32
| Recall number | Product, codes & lots |
|---|---|
| D-0636-2020 | Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-031-05; Lot #: 03119002A3, Exp 3/2022 |
| D-0637-2020 | Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-001-05; Lot #: 03119002A3, Exp 3/2022 |
What to do — step by step
Check Label
Verify the label on the bottle to ensure it states 15mg, not 7.5mg.
Questions people ask
Why is this product being recalled?
The product was recalled due to a labeling error where 500-count Mirtazapine 15mg tablets were labeled as 7.5mg.
What should I do if I have this product?
Check the label to confirm the strength. If it's labeled as 7.5mg but contains 15mg, contact your healthcare provider for guidance.
Is there a specific time frame to act?
The official recall notice does not specify a deadline for action.
Contact AuroMedics
We’ve drafted a message you can send AuroMedics to request your refund or repair — edit it as you like.
Subject: Recall D-0636-2020 — AuroMedics AuroMedics Hello, I own a AuroMedics that is covered by recall D-0636-2020 from AuroMedics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0636-2020 (November 20, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0636-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.