Drug recall D-0488-2025
Product
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.
Reason for recall
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Lots and codes
Lot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027
Recall details
- Recalling firm
- Amneal Pharmaceuticals, LLC, Bridgewater, NJ
- Quantity
- 6396 bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 2, 2025
Related products
- Sulfamethoxazole and Trimethoprim – drug information
- NDC 65162-272 Sulfamethoxazole and Trimethoprim · Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 · Amneal Pharmaceuticals LLC
- NDC 65162-271 Sulfamethoxazole and Trimethoprim · Sulfamethoxazole 400 mg/1; Trimethoprim 80 mg/1 · Amneal Pharmaceuticals LLC