Medications & Supplements/Prescription Drugs

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

Agency Publication Date: August 21, 2020

Summary

Aurobindo Pharma USA Inc. is recalling 5,748 bottles of Sulfamethoxazole and Trimethoprim Double Strength Tablets (800 mg/160 mg) because metal wire was found embedded in the tablets. This prescription antibiotic is sold in 500-count bottles and was distributed nationwide. The recall was initiated after the company received product complaints reporting the presence of these foreign metal objects.

Risk

If a tablet containing a metal wire is swallowed, it could cause serious internal injury, including cuts or perforation of the digestive tract or mouth. The presence of foreign metal objects in medication poses a significant choking hazard and physical trauma risk to patients.

What You Should Do

Check your prescription bottle for Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength (500 tablets per bottle) with NDC 65862-420-05.
Identify if your bottle belongs to one of the affected lots: STSD19109-A (Expiration 05/31/2022), SP1D19083AA3 (Expiration 08/31/2022), or SP1D19084AA3 (Expiration 08/31/2022).
If your medication matches these lot numbers, stop taking it immediately and contact your healthcare provider or pharmacist to discuss an alternative treatment or a replacement prescription.
Return any remaining tablets or the bottle to your pharmacy for a refund and to ensure the defective product is properly handled.
Contact Aurobindo Pharma USA Inc. for further instructions regarding this recall at their East Windsor, New Jersey location.
For additional questions or to report a problem, 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

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

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

Affected Products

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

Model:

NDC: 65862-420-05

Lot Numbers:

STSD19109-A (Exp. 05/31/2022)

SP1D19083AA3 (Exp. 08/31/2022)

SP1D19084AA3 (Exp. 08/31/2022)

Date Ranges: Expiration 05/31/2022, Expiration 08/31/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86190

Status: Resolved

Manufacturer: Aurobindo Pharma USA Inc.

Manufactured In: India, United States

Units Affected: 5748 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, 800 mg/160 mg Double Strength (500 tablets per bottle) with NDC 65862-420-05.

Identify if your bottle belongs to one of the affected lots: STSD19109-A (Expiration 05/31/2022), SP1D19083AA3 (Expiration 08/31/2022), or SP1D19084AA3 (Expiration 08/31/2022).

If your medication matches these lot numbers, stop taking it immediately and contact your healthcare provider or pharmacist to discuss an alternative treatment or a replacement prescription.

Return any remaining tablets or the bottle to your pharmacy for a refund and to ensure the defective product is properly handled.

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

For additional questions or to report a problem, 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

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

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