Aurobindo Recalls Mirtazapine Tablets Due to Manufacturing Water Leakage
Aurobindo Pharma USA Inc. is recalling Mirtazapine Tablets 15mg due to water leakage observed in the manufacturing area.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a manufacturing deviation (water leakage) without reported illnesses, fitting the Moderate category for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Mirtazapine Tablets, USP 15mg, 30-count bottles. The affected product is identified by Lot # 031180028A and an expiration date of 03/2021. The recall involves 56,208 units distributed nationwide within the United States.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the products were manufactured in a processing area where water leakage was observed. This condition may compromise the quality or safety of the medication.
Consumers who have this specific lot of Mirtazapine Tablets should stop using the product and contact their healthcare provider or pharmacist for guidance. The product is a prescription-only medication distributed by Aurobindo Pharma USA, Inc. in Dayton, NJ.
The recalled product
- Product
- MIRTAZAPINE (MIRTAZAPINE)
- Brand
- MIRTAZAPINE
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 56,208
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 031180028A
- Exp. Date 03/2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Aurobindo Pharma USA Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
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