FlaggedRx← Medication recall checkHome
Class I · Most seriousActive recall

Sulfamethoxazole And Trimethoprim

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027
Where it was soldNationwide in the USA
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

Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial 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 byAmneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 foreign manufacturer
Brand nameSULFAMETHOXAZOLE AND TRIMETHOPRIM
Generic nameSULFAMETHOXAZOLE AND TRIMETHOPRIM
Active ingredient(s)SULFAMETHOXAZOLE, TRIMETHOPRIM
Distributed by / forAmneal Pharmaceuticals LLC, Bridgewater, NJ 08807
NDC65162-271-10
Show the full FDA record
Full product labelSulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.
Recalling firmAmneal Pharmaceuticals, LLC
DistributionNationwide in the USA
Quantity6396 bottles
Recall initiated2025-06-02
Report date2025-06-18
Recall completed—
Recall numberD-0488-2025
ClassificationClass I
FDA statusOngoing
Origin on fileBridgewater 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.