Mirtazapine Tablets — Class I drug recall D-0637-2020
Terminated recall by AuroMedics Pharma LLC, reported 2019-12-18, distributed nationwide. Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contai
| Recall number | D-0637-2020 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AuroMedics Pharma LLC, East Windsor, NJ, United States |
| Recall initiated | 2019-11-20 |
| Classified | 2020-01-02 |
| Reported by FDA | 2019-12-18 |
| Terminated | 2024-02-21 |
| Distributed | Nationwide (US) |
| Reason classes | labeling, potency |
| NDC | 13107-0001, 13107-0001-01, 13107-0001-05, 13107-0001-30, 13107-0001-60, 13107-0001-90, 13107-0003, 13107-0003-01, 13107-0003-05, 13107-0003-30, 13107-0003-32, 13107-0003-34, 13107-0003-60, 13107-0003-90, 13107-0031, 13107-0031-01, 13107-0031-05, 13107-0031-30, 13107-0031-32, 13107-0031-34, 13107-0031-60, 13107-0031-90, 13107-0032, 13107-0032-01, 13107-0032-05 and 4 more |
| Lot numbers | 03119002A3 |
| Expiration dates | 2022-03 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0637-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.