Sun Pharmaceutical Industries, Inc. recalls Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioPharm,
Sun Pharma recalls 500-count sulfamethoxazole and trimethoprim tablets (800mg/160mg) with polyethylene foreign matter in two tablets. Rx-only medication from lot 6848501 (exp 04/2020) needs replacement.
Lower-risk recall
Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as polyethylene was detected in two (2) tablets.
Contact the company & request your remedy
What happened, in plain English
Sun Pharma is recalling a specific lot of prescription sulfamethoxazole and trimethoprim tablets due to polyethylene foreign matter found in two tablets. This could cause harm if taken, so affected patients should stop using the medication and contact their doctor. Read more at govinfonow.com/recall/40609-sun-pharma-recalls-sulfamethoxazole-trimethoprim-tablets-due-to-polyethylene-foreign.
Source Summary by GovInfoNow · govinfonow.com/recall/40609-sun-pharma-recalls-sulfamethoxazole-trimethoprim-tablets-due-to-polyethylene-foreign · Updated October 7, 2026 · FDA enforcement record: FDA #D-0802-2018
Cite this page
“Sun Pharma Recalls Sulfamethoxazole/Trimethoprim Tablets Due to Polyethylene Foreign Matter.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40609-sun-pharma-recalls-sulfamethoxazole-trimethoprim-tablets-due-to-polyethylene-foreign. Based on FDA recall #D-0802-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0802-2018%22&limit=1).
Why it’s dangerous
Polyethylene is a type of plastic foreign material that could be ingested with the medication. While only two tablets were found to contain this foreign substance, taking the medication with the foreign material could cause harm.
Who’s affected
Prescription patients with the specific lot number (6848501) who have the 500-count bottle of sulfamethoxazole and trimethoprim tablets (800mg/160mg). Patients who take this medication regularly are most at risk.
How to tell if you have this one
Check your prescription bottle for the lot number 6848501 (expires 04/2020) and the NDC code 53489-146-05. The product is a 500-count bottle of sulfamethoxazole and trimethoprim tablets (800mg/160mg) that requires a prescription.
- Brand
Sun Pharma- Category
Drug
What to do — step by step
Stop Using Medication
Discard the recalled tablets immediately and contact your doctor for a replacement.
Questions people ask
Is this medication safe to take?
No, the recalled lot contains polyethylene foreign matter in two tablets. Do not take this medication.
How do I know if I have the recalled product?
Check for lot number 6848501 (expires 04/2020) and NDC code 53489-146-05 on the 500-count prescription bottle.
What should I do if I have the recalled product?
Discard the medication immediately and contact your doctor for a replacement.
Contact Sun Pharma
We’ve drafted a message you can send Sun Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0802-2018 — Sun Pharma Sun Pharma Hello, I own a Sun Pharma that is covered by recall D-0802-2018 from Sun Pharma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0802-2018 (April 19, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0802-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.