Medications & Supplements/Prescription Drugs

Sun Pharmaceutical Industries, Inc.: Sulfamethoxazole and Trimethoprim Tablets Recalled for Foreign Substance

Agency Publication Date: May 11, 2018

Summary

Sun Pharmaceutical Industries, Inc. is recalling 1,908 bottles of Sulfamethoxazole and Trimethoprim Tablets USP (800 mg/160 mg), a prescription antibiotic used to treat various bacterial infections. This recall was initiated because two tablets were found to contain polyethylene, a type of plastic foreign matter. Consumers should be aware that this recall affects the 500-count bottles distributed nationwide in the United States.

Risk

The presence of foreign material like polyethylene in a medication can cause choking or irritation if swallowed, and in some cases, it may reduce the effectiveness of the treatment or cause unforeseen adverse reactions.

What You Should Do

Check your medication bottle for the product name 'Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg' in 500-count bottles.
Verify if your bottle belongs to the affected lot: Lot 6848501 with an expiration date of 04/2020.
Check the label for NDC 53489-146-05 to confirm it is the recalled product.
If you have this medication, stop using it immediately and contact your healthcare provider or pharmacist for guidance on an alternative treatment.
Return any unused product to the pharmacy where it was purchased for a refund.
Contact Sun Pharmaceutical Industries, Inc. at their distributor location in Cranbury, NJ, or your pharmacist 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

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

Model:

NDC 53489-146-05

Recall #: D-0802-2018

Lot Numbers:

6848501 (EXP 04/2020)

Date Ranges: Expiration 04/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79909

Status: Resolved

Manufacturer: Sun Pharmaceutical Industries, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 1,908 500-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 medication bottle for the product name 'Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg' in 500-count bottles.

Verify if your bottle belongs to the affected lot: Lot 6848501 with an expiration date of 04/2020.

Check the label for NDC 53489-146-05 to confirm it is the recalled product.

If you have this medication, stop using it immediately and contact your healthcare provider or pharmacist for guidance on an alternative treatment.

Return any unused product to the pharmacy where it was purchased for a refund.

Contact Sun Pharmaceutical Industries, Inc. at their distributor location in Cranbury, NJ, or your pharmacist 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.