Amneal Pharmaceuticals recalls 400mg/80mg sulfamethoxazole and trimethoprim tablets with black spots due to microbial contamination. Stop using affected lots immediately.
“Amneal Sulfamethoxazole-Trimethoprim Tablets Recall: Microbial Contamination Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/32039-amneal-sulfamethoxazole-trimethoprim-tablets-recall-microbial-contamination-risk. Based on FDA recall #D-0488-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0488-2025%22&limit=1).
The FDA announced on June 2, 2025, that Amneal Pharmaceuticals is voluntarily recalling Sulfamethoxazole and Trimethoprim Tablets due to potential microbial contamination. The agency stated the tablets may exhibit black spots caused by this contamination.
How to tell if you have it
Brand: Amneal
Product: Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg
NDC: 65162-271-10 (100 Tablets per Bottle)
NDC: 65162-271-50 (500 Tablets per Bottle)
Lot codes: AM241019, AM241020, AM241019A
Expiration date: 06/30/2027
Distribution: Nationwide in the USA
The hazard
According to the FDA, the non-sterile tablets may exhibit black spots due to microbial contamination. The recall is classified as Class I.
Context
GovInfoNow's records show Amneal Pharmaceuticals has 9 other recalls on record since December 12, 2016. Other recent recalls of similar products include the Amneal Estradiol Gel Recall (September 8, 2026) and the Amneal Primidone Tablets Recall (June 3, 2026). Public reports from FDA's FAERS database list 14,520 adverse-event reports naming this product, with 12,930 marked serious and 2,781 listing a death.
How to tell if you have this one
Check for black spots on the tablets. Affected lots have NDC numbers 65162-271-10 (100 tablets) or 65162-271-50 (500 tablets), manufactured in India with specific lot numbers.
Brand
Amneal
Category
Drug
Based on the official FDA remedy
What to do — step by step
Stop using affected tablets
Discard any tablets with black spots as they may contain harmful microbes.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
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 published this recall 16 days after the firm started it.
1Firm started the recall
2Published in FDA’s Enforcement Report
3FDA classified it Class I
Dates from the agency record only; steps without a date are left out.
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-0488-2025 (June 2, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0488-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.