Drug Safety Alerts

Aurobindo Pharma Mirtazapine Tablets Consumer-Level Recall

12/30/2019

On December 30, 2019, the United States Food and Drug Administration (FDA) published a notice regarding a consumer-level recall of Mirtazapine 7.5 mg and 15 mg tablets manufactured by Aurobindo Pharma USA, Inc. This recall was issued due to a label error on declared strength; bottles labeled as Mirtazapine 7.5 mg may contain 15 mg tablets.

A list of the affected products is provided here:

This could be a health hazard or safety risk to patients who may be using product affected by this recall.

Taking a higher dose than expected may increase risk of sedation, agitation, increased reflexes, tremor, sweating, dilated pupils, gastrointestinal distress, nausea, constipation and more. Unexpected levels of sedation in particular can contribute to falls in the elderly or motor vehicle accidents in adults.

Mirtazapine 7.5 mg and 15 mg tablets are indicated for the treatment of major depressive disorders. The affected lot number for both Mirtazapine Tablets 7.5 mg and Mirtazapine Tablets 15 mg are 03119002A3 exp. 03/2022.

CVS Caremark Response: Because of this action, CVS Caremark® is contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking Mirtazapine tablets to contact their prescriber.

For more information about this recall, please contact Aurobindo at 1-866-850-2876 and select option 2 or visit www.aurobindousa.com. You may also contact the FDA at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov.