FDA Recall D-0488-2025

Amneal Pharmaceuticals, LLC · Bridgewater, NJ

Class I — life-threatening Ongoing 346 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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.

Lot / code: Lot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027

Quantity: 6396 bottles

Reason for recall

Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.

Recall record

Recall number: D-0488-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide in the USA
Recall initiated: 2025-06-02
Classified by FDA Center: 2025-06-23
FDA published: 2025-06-18
Recalling firm: Amneal Pharmaceuticals, LLC
Firm location: Bridgewater, NJ

Drug identification

Brand name(s): SULFAMETHOXAZOLE AND TRIMETHOPRIM
Generic name(s): SULFAMETHOXAZOLE AND TRIMETHOPRIM
Manufacturer(s): Amneal Pharmaceuticals LLC
NDC(s): 65162-271, 65162-272
Route(s): ORAL

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls