Reported Sep 10, 2025 · Ongoing
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle,…
Amneal Pharmaceuticals, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Amneal Pharmaceuticals, LLC · 400 Crossing Blvd Fl 3 · Bridgewater, NJ · 08807-2863
Is this the product you have?
Sulfamethoxazole and Trimethoprim TabletsUSP 800mg/160mgDouble StrengthRx OnlyPackaged as a) 100-count bottleNDC 65162-272-10b) 500-count bottleNDC 65162-272-50
- Manufactured byAmneal Pharmaceuticals, Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA
- Distributed byAmneal Pharmaceuticals LLC, Bridgewater, NJ 08807
- Lot codes and dates
Lot a) AM240173Exp Date 01/31/2027AM240680Exp Date 05/31/2027AM 240921Exp Date 06/30/2027AM241191Exp Date 08/31/2027. Lot b) AM240176AM240177Exp Date 01/31/2027AM240301AM240300Exp Date 02/28/2027AM240676AM240677Exp Date 04/30/2027AM240678AM240679Exp Date 05/30/2027. AM240922AM240923AM240924AM240925Exp Date 6/30/27AM241086Exp Date 7/31/27AM241087AM241088Exp Date 8/31/27
- Amount recalled
- 60,072 100-count, 73,054 500-count bottles
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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