Recall D-0488-2025

US Class I Ongoing · initiated 2025-06-02

Recalling firm

Amneal Pharmaceuticals, LLC, NJ

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.

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