Sulfamethoxazole and Trimethoprim Tablets recall
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.
Why was Sulfamethoxazole and Trimethoprim Tablets recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- 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.
- Recalling firm
- Amneal Pharmaceuticals, LLC
- Quantity
- 60,072 100-count, 73,054 500-count bottles
- Distribution
- Distributed Nationwide in the USA
- Recall date
- September 10, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)