Sulfamethoxazole And Trimethoprim Tablet
FDA Recall NDC 65162-271
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Sulfamethoxazole And Trimethoprim (NDC 65162-271). A significant event, classified as Class II, was initiated on Aug 18, 2025 by Amneal Pharmaceuticals Llc. The reported reason for this action was: "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."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
August 2025 Class II 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.
Recall Number
Class II Ongoing
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.
Aug 18, 2025
Sep 10, 2025
60,072 100-count, 73,054 500-count bottles
Recall Profile & Regulatory Data
Event ID
97438
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amneal Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Product Description
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.
Batch or Lot Expiration Information
Lot# 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.
Affected Packages Involved in this Recall
65162-271-05Product
65162-271-10Product
65162-271-50Product
65162-271-11Product
65162-272-01Product
65162-272-24Product
65162-272-10Product
65162-272-25Product
65162-272-50Product
Class I Ongoing
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Jun 02, 2025
Jun 18, 2025
6396 bottles
Recall Profile & Regulatory Data
Event ID
96985
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Amneal Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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.
Batch or Lot Expiration Information
Lot# s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027
Affected Packages Involved in this Recall
65162-271-05Product
65162-271-10Product
65162-271-50Product
65162-271-11Product
65162-272-01Product
65162-272-24Product
65162-272-10Product
65162-272-25Product
65162-272-50Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
