Medications & Supplements/Prescription Drugs

Aurobindo Pharma USA Inc.: Amphetamine Mixed Salts 20mg Tablets Recalled for Superpotency Risk

Agency Publication Date: October 15, 2019

Summary

Aurobindo Pharma USA Inc. is recalling 11,129 bottles of Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Amphetamine Mixed Salts) 20mg tablets. This prescription medication, often used to treat ADHD, was found to be 'superpotent' because the tablets were manufactured outside of the required specifications for weight and thickness. This means a patient could unintentionally receive a higher dose of the medication than prescribed, which can lead to serious adverse health effects.

Risk

Taking a superpotent dose of amphetamine mixed salts can cause severe side effects such as dangerously high blood pressure, rapid heart rate, anxiety, and other cardiovascular or neurological complications.

What You Should Do

Check your prescription bottle for the product name: Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 20mg (Mixed Salts of a single Entity Amphetamine Product).
Verify if your medication is part of the affected batch by looking for Batch Number 07319032A1 with an expiration date of 02/2021 and NDC 13107-073-01 on the 100-count bottle label.
If you have the affected medication, contact your healthcare provider or pharmacist immediately for guidance on how to safely proceed with your treatment and to obtain a replacement.
Return any unused tablets from the affected batch to your pharmacy for a refund.
Contact Aurobindo Pharma USA Inc. at their East Windsor, New Jersey location for further instructions regarding this recall.
For additional questions or to report a complaint, contact the FDA Consumer Complaint line 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 return

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

Affected Products

Product: Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 20mg (100-count bottle)

Model:

NDC 13107-073-01

Recall #: D-0143-2020

Lot Numbers:

07319032A1 (Exp 02/2021)

Date Ranges: Expiration 02/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83848

Status: Resolved

Manufacturer: Aurobindo Pharma USA Inc.

Sold By: pharmacies; healthcare providers

Manufactured In: United States

Units Affected: 11,129 100-count bottles

Distributed To: Nationwide

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 · 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.

Summary

What You Should Do

Check your prescription bottle for the product name: Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 20mg (Mixed Salts of a single Entity Amphetamine Product).

Verify if your medication is part of the affected batch by looking for Batch Number 07319032A1 with an expiration date of 02/2021 and NDC 13107-073-01 on the 100-count bottle label.

If you have the affected medication, contact your healthcare provider or pharmacist immediately for guidance on how to safely proceed with your treatment and to obtain a replacement.

Return any unused tablets from the affected batch to your pharmacy for a refund.

Contact Aurobindo Pharma USA Inc. at their East Windsor, New Jersey location for further instructions regarding this recall.

For additional questions or to report a complaint, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.