Medications & Supplements/Prescription Drugs

Aurobindo Pharma USA Inc.: Sulfamethoxazole and Trimethoprim Tablets Recalled for Metal Contamination

Agency Publication Date: August 10, 2021

Summary

Aurobindo Pharma USA Inc. is recalling approximately 3,800 bottles of Sulfamethoxazole and Trimethoprim (800mg/160mg) Double Strength tablets. This prescription antibiotic is being recalled because it may contain foreign metal particles. If you have this medication at home, you should check your bottle immediately to see if it is part of the affected batches.

Risk

The presence of metal fragments in oral medication can cause internal injury or irritation to the digestive system if swallowed. No specific injuries have been reported at the time of this recall notification.

What You Should Do

Check your prescription bottle for Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength in 500-count bottles with NDC 65862-420-05.
Look for Batch numbers SP1D19082AA3 or SP1D19085AA3 with an expiration date of 08/2022 to determine if your medication is affected.
If you have an affected bottle, contact your healthcare provider or pharmacist immediately to discuss continuing your treatment and obtaining a safe replacement.
Return any unused tablets from the affected batches to your pharmacy to receive a refund.
Contact Aurobindo Pharma USA Inc. at their East Windsor, New Jersey location for further instructions regarding this recall.
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

Medical guidance and refund

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

Affected Products

Product: Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength (500-count bottle)

Model:

NDC 65862-420-05

Lot Numbers:

SP1D19082AA3 (Exp 08/2022)

SP1D19085AA3 (Exp 08/2022)

Date Ranges: Exp 08/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88227

Status: Resolved

Manufacturer: Aurobindo Pharma USA Inc.

Sold By: pharmacies; healthcare providers

Manufactured In: India, United States

Units Affected: 3800 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 Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength in 500-count bottles with NDC 65862-420-05.

Look for Batch numbers SP1D19082AA3 or SP1D19085AA3 with an expiration date of 08/2022 to determine if your medication is affected.

If you have an affected bottle, contact your healthcare provider or pharmacist immediately to discuss continuing your treatment and obtaining a safe replacement.

Return any unused tablets from the affected batches to your pharmacy to receive a refund.

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

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