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Class II · ModerateRecall completed

Sulfamethoxazole And Trimethoprim

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberBatch SP1D19082AA3 & Batch SP1D19085AA3; Exp 08/2022
Where it was soldNationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Presence of Foreign Substance- Potential of metal contamination.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in India foreign manufacturer
Brand nameSULFAMETHOXAZOLE AND TRIMETHOPRIM
Generic nameSULFAMETHOXAZOLE AND TRIMETHOPRIM
Active ingredient(s)SULFAMETHOXAZOLE, TRIMETHOPRIM
Distributed by / forAurobindo Pharma USA, Inc. 279 Princeton-HIghtstown Road, EAs Windsor, NJ 08520
NDC65862-420-05
Show the full FDA record
Full product labelSulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-HIghtstown Road, EAs Windsor, NJ 08520, Made in India, NDC 65862-420-05
Recalling firmAurobindo Pharma USA Inc.
DistributionNationwide
Quantity3800 bottles
Recall initiated2021-07-07
Report date2021-08-18
Recall completed2023-10-18
Recall numberD-0719-2021
ClassificationClass II
FDA statusTerminated
Origin on fileEast Windsor NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.