Aurobindo Pharma Sulfamethoxazole-Trimethoprim Tablets Recall: Metal Contamination Risk
Aurobindo Pharma recalls 500-tablet sulfamethoxazole-trimethoprim (800mg/160mg) prescription medication due to potential metal contamination. This recall affects specific batches made in India with NDC 65862-420-05.
“Aurobindo Pharma Sulfamethoxazole-Trimethoprim Tablets Recall: Metal Contamination Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/36099-aurobindo-pharma-sulfamethoxazole-trimethoprim-tablets-recall-metal-contamination-risk. Based on FDA recall #D-0719-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0719-2021%22&limit=1).
Aurobindo Pharma USA Inc. recalled Sulfamethoxazole and Trimethoprim Tablets, USP due to potential metal contamination, the FDA announced on July 7, 2021. The voluntary Class II recall affects 3,800 bottles distributed nationwide.
How to tell if you have it
Brand: Aurobindo Pharma
Product: Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength
Quantity: 500 Tablets per bottle
NDC: 65862-420-05
Lot codes: SP1D19082AA3 and SP1D19085AA3
Expiration date: 08/2022
Distribution: Nationwide
The hazard
The recall cites the presence of a foreign substance, specifically potential metal contamination. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Aurobindo Pharma USA Inc. has issued 32 other recalls since April 9, 2013. Recent brand recalls include Dicyclomine Capsules recalled on July 23, 2026, for empty capsules and Acetaminophen Tablets recalled on May 22, 2025, due to discoloration risk. Other recent recalls of similar products include Guardian Drug Goodsense Ultra Strength Antacid Tablets (May 28, 2026) and Merck Noxafil Powdermix (Dec. 12, 2025).
How to tell if you have this one
Check for the NDC code 65862-420-05 on the packaging. Look for batch numbers SP1D19082AA3 or SP1D19085AA3. These tablets were made in India and expire in August 2022.
Brand
Aurobindo Pharma
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the NDC code 65862-420-05 and batch numbers SP1D19082AA3 or SP1D19085AA3 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-0719-2021 (July 7, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0719-2021 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.