Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-272-50; Manufactured by: Amneal Pharmaceuticals, Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.
This recall is currently active, issued September 10, 2025. It was issued by Amneal Pharmaceuticals, Llc.
- Company
- Amneal Pharmaceuticals, Llc
- Recall Initiated
- August 18, 2025
- Posted
- September 10, 2025
- Recall Number
- D-0615-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 60,072 100-count, 73,054 500-count bottles
- Firm Location
- Bridgewater, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Distribution
Distributed Nationwide in the USA
Lot / Code Info
Lot a) AM240173, Exp Date 01/31/2027, AM240680, Exp Date 05/31/2027, AM 240921, Exp Date 06/30/2027, AM241191, Exp Date 08/31/2027. Lot b) AM240176, AM240177, Exp Date 01/31/2027, AM240301, AM240300, Exp Date 02/28/2027, AM240676, AM240677, Exp Date 04/30/2027, AM240678, AM240679, Exp Date 05/30/2027. AM240922, AM240923, AM240924, AM240925, Exp Date 6/30/27, AM241086, Exp Date 7/31/27, AM241087, AM241088, Exp Date 8/31/27.