Drug Recall: 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 Pharmaceutica
Amneal Pharmaceuticals, LLC · June 2, 2025
Reason for Recall
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
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.
Distribution
Nationwide in the USA
States Affected
NATIONWIDE
Quantity Affected
6396 bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0488-2025
Status: ongoing
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