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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

AuroMedics Pharma LLC: Mirtazapine Tablets Recalled Due to Labeling Error on Strength

Agency Publication Date: December 10, 2019
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Summary

AuroMedics Pharma LLC has recalled Mirtazapine (mirtazapine) 15 mg and 7.5 mg tablets in 500-count bottles because some bottles were mislabeled with the wrong strength. Some cases labeled as 15 mg tablets contain bottles labeled as 7.5 mg, which could lead to patients taking the incorrect dosage. Consumers should contact their healthcare provider or pharmacist immediately to determine if their medication is affected and to discuss potential health impacts.

Risk

A labeling error regarding the drug strength can lead to patients taking a significantly higher or lower dose of medication than prescribed. Taking an incorrect dose of Mirtazapine, which is used for treating depression, can result in ineffective treatment or unintended side effects.

What You Should Do

  1. Check your prescription bottle for Mirtazapine Tablets, USP, 15 mg (NDC 13107-031-05) or Mirtazapine Tablets, USP, 7.5 mg (NDC 13107-001-05) with Lot Number 03119002A3 and an expiration date of 3/2022.
  2. Examine the outer shipping case if available to see if it is labeled as 15 mg tablets while containing bottles labeled as 7.5 mg.
  3. If you identify an affected bottle, contact your healthcare provider or pharmacist for guidance on how to obtain a correct replacement.
  4. Return any unused or mislabeled product to the place of purchase for a refund.
  5. Contact AuroMedics Pharma LLC or Aurobindo Pharma USA, Inc. for further instructions regarding this recall.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Healthcare provider consultation and pharmacy refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Mirtazapine Tablets, USP, 15 mg (500-count)
Model:
NDC 13107-031-05
Recall #: D-0636-2020
Lot Numbers:
03119002A3 (Exp 3/2022)
Date Ranges: Exp 3/2022
Product: Mirtazapine Tablets, USP, 7.5 mg (500-count)
Model:
NDC 13107-001-05
Recall #: D-0637-2020
Lot Numbers:
03119002A3 (Exp 3/2022)
Date Ranges: Exp 3/2022

Product Images

“Product label, Aurobindo Pharma USA, Inc. Mirtazapine Tablets, USP 7.5 mg 500 Tablets NDC 13107-001-05”

“Product label, Aurobindo Pharma USA, Inc. Mirtazapine Tablets, USP 7.5 mg 500 Tablets NDC 13107-001-05”

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84336
Status: Resolved
Manufacturer: AuroMedics Pharma LLC
Sold By: Aurobindo Pharma USA, Inc.
Manufactured In: United States
Distributed To: Nationwide
Agency Last Updated: January 2, 2020

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.