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# Aurobindo Recalls Mirtazapine Over Label Error
- URL: https://www.fdaweb.com/aurobindo-recalls-mirtazapine-over-label-error/
- Published: 2020-01-02T12:00:00.000Z
- Updated: 2026-09-14T15:56:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145742

Aurobindo Pharma has recalled one lot of mirtazapine due to a label error on declared strength; bottles labeled as mirtazapine 7.5 mg may contain 15 mg tablets. “Taking a higher dose than expected may increase risk of sedation, agitation, increased reflexes, tremor, sweating, dilated pupils, gastrointestinal distress, nausea, constipation and more,” a [recall notice](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-usa-inc-issues-voluntary-nationwide-recall-mirtazapine-tablets-lot-number?utm%5Fcampaign=FDA%20MedWatch%20Mirtazapine%20Tablets%20by%20Aurobindo%20Pharma&utm%5Fmedium=email&utm%5Fsource=Eloqua) says. Mirtazapine is indicated for treating major depressive disorder and is packaged in 500-count bottles.