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Class II · ModerateActive recall

Sulfamethoxazole And Trimethoprim

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

Does this affect you?
Check your lot numberLot a) AM240173, Exp Date 01/31/2027, AM240680, Exp Date 05/31/2027, AM 240921, Exp Date 06/30/2027, AM241191, Exp Date 08/31/2027. Lot b) AM240176, AM240177, Exp Date 01/31/2027, AM240301, AM240300, Exp Date 02/28/2027, AM240676, AM240677, Exp Date 04/30/2027, AM240678, AM240679, Exp Date 05/30/2027. AM240922, AM240923, AM240924, AM240925, Exp Date 6/30/27, AM241086, Exp Date 7/31/27, AM241087, AM241088, Exp Date 8/31/27.
Where it was soldDistributed Nationwide 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

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

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
NDC65162-272-10
Show the full FDA record
Full product labelSulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-272-50; 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
DistributionDistributed Nationwide in the USA
Quantity60,072 100-count, 73,054 500-count bottles
Recall initiated2025-08-18
Report date2025-09-10
Recall completed—
Recall numberD-0615-2025
ClassificationClass II
FDA statusOngoing
Origin on fileBridgewater NJ United States

Related

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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.