Sun Pharma Recalls Sulfamethoxazole/Trimethoprim Tablets Due to Foreign Matter
Sun Pharmaceutical recalls one lot of 500-count Sulfamethoxazole/Trimethoprim tablets due to polyethylene fragments found in two tablets.
Use caution until it’s fixed
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.
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What happened, in plain English
Sun Pharmaceutical Industries is recalling one specific lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, because foreign matter identified as polyethylene was detected in two tablets within the batch. The affected product is distributed in 500-count bottles manufactured by Frontida BioPharm. Consumers should check their medication against the specific lot number to determine if it is part of this recall. Read more at govinfonow.com/recall/40609-sun-pharma-recalls-sulfamethoxazole-trimethoprim-tablets-due-to-foreign-matter.
Source Summary by GovInfoNow · govinfonow.com/recall/40609-sun-pharma-recalls-sulfamethoxazole-trimethoprim-tablets-due-to-foreign-matter · Updated October 11, 2026 · FDA enforcement record: FDA #D-0802-2018
Cite this page
“Sun Pharma Recalls Sulfamethoxazole/Trimethoprim Tablets Due to Foreign Matter.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/40609-sun-pharma-recalls-sulfamethoxazole-trimethoprim-tablets-due-to-foreign-matter. 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
The presence of polyethylene, a type of plastic, in the tablets poses a risk of ingestion of non-food material. Although only two tablets were affected out of nearly 2 million, ingesting foreign substances can cause physical harm or contamination.
Who’s affected
Patients who have been prescribed or possess Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg in 500-count bottles from the specific lot number. While the hazard is limited to two tablets containing foreign matter, anyone using this medication should verify their supply.
How to tell if you have this one
Check your bottle for NDC 53489-146-05 and Lot number 6848501 with an expiration date of 04/2020. The product is a 500-count bottle of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only.
- Brand
Sun Pharma- Category
Drug
What to do — step by step
Check Your Lot Number
Verify if your bottle has NDC 53489-146-05 and Lot 6848501 with EXP 04/2020.
Contact Your Pharmacist
If you have the recalled lot, contact your pharmacy or healthcare provider for instructions on replacement or disposal.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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 qwen3.6:35b-a3b on October 11, 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.