RecallRadar

FDA Drug recall D-0636-2020

Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc

On 2019-12-18 the FDA classified a Class I recall of Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc by Auromedics Pharma, citing labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapi….

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0636-2020
ClassificationClass I
Statusterminated
Initiated2019-11-20
Published2019-12-18
Last updated2026-09-13 11:52 UTC
CompanyAuromedics Pharma
DistributionUS

Product

Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-031-05

Reason

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.

Identifiers

ndc13107-001-30
ndc13107-001-60
ndc13107-001-90
ndc13107-001-01
ndc13107-001-05
ndc13107-031-30
ndc13107-031-34
ndc13107-031-60
ndc13107-031-90
ndc13107-031-01
ndc13107-031-05
ndc13107-031-32
ndc13107-003-30
ndc13107-003-34
ndc13107-003-60
ndc13107-003-90
ndc13107-003-01
ndc13107-003-05
ndc13107-003-32
ndc13107-032-34
ndc13107-032-60
ndc13107-032-90
ndc13107-032-01
ndc13107-032-05
ndc13107-032-32
code_infoLot #: 03119002A3, Exp 3/2022

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0636-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.