FDA Drug recall D-1235-2020

Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc

FDA Drug
Class II
terminated
Published 2020-04-22

On 2020-04-22 the FDA classified a Class II recall of Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc by Aurobindo Pharma Usa, citing CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-1235-2020
Classification	Class II
Status	terminated
Initiated	2020-03-18
Published	2020-04-22
Last updated	2026-09-13 11:52 UTC
Company	Aurobindo Pharma Usa
Distribution	US

Product

Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34

Reason

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Identifiers

ndc	13107-001-30
ndc	13107-001-60
ndc	13107-001-90
ndc	13107-001-01
ndc	13107-001-05
ndc	13107-031-30
ndc	13107-031-34
ndc	13107-031-60
ndc	13107-031-90
ndc	13107-031-01
ndc	13107-031-05
ndc	13107-031-32
ndc	13107-003-30
ndc	13107-003-34
ndc	13107-003-60
ndc	13107-003-90
ndc	13107-003-01
ndc	13107-003-05
ndc	13107-003-32
ndc	13107-032-34
ndc	13107-032-60
ndc	13107-032-90
ndc	13107-032-01
ndc	13107-032-05
ndc	13107-032-32
code_info	Lot #: 031180028A, Exp. Date 03/2021

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-1235-2020%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.