Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle,...
FDA Recall #D-0488-2025 — Class I — June 2, 2025
Product Description
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.
Recalling Firm
Amneal Pharmaceuticals, LLC — Bridgewater, NJ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
6396 bottles
Distribution
Nationwide in the USA
Code Information
Lot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated