FDAFDA · Food and drugs·Recall number D-0488-2025
Sulfamethoxazole 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.
Published June 18, 2025 · Recall initiated: June 2, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Brand
- SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Manufacturer
- Amneal Pharmaceuticals, LLC
- Distributor
- Nationwide in the USA
- UPC
- 0365168211102
- Lot
- Lot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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