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CHEMICAL & LIFE SCIENCES INTELLIGENCE
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Sulfamethoxazole

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Intermediate-acting sulfonamides

CAS723-46-6HSN29419090
THERAPEUTIC AREAS
MOLECULE INTELLIGENCE SNAPSHOTlive
10
Manufacturers monitored
2
Intelligence briefs
0
Active regulatory actions
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INTELLIGENCE

Showing 2 of 2 briefs for Sulfamethoxazole
REGULATORY INTELLIGENCE·Recall

FDA Class II Recall: Major Pharmaceuticals' Sulfamethoxazole and Trimethoprim Tablets Impacted by Packaging Contamination from Amneal

The Harvard Drug Group LLC dba Major Pharmaceuticals has initiated a Class II recall of Sulfamethoxazole and Trimethoprim tablets due to microorganism contamination on auxiliary polyester coil packaging supplied by Amneal Pharmaceuticals LLC. This nationwide recall, D-0624-2025, highlights critical supply chain vulnerabilities in packaging components, demanding immediate action from procurement and quality assurance teams to mitigate disruption and ensure patient safety.

90-Day Activity
SulfamethoxazoleHSN 3004.90
MKMeera Krishnan· Senior Regulatory Intelligence Analyst
2025-09-17
REGULATORY INTELLIGENCE·Recall

FDA Initiates Class II Recall for Sulfamethoxazole and Trimethoprim Due to Packaging Contamination

Cardinal Health 107, LLC faces a Class II FDA recall for Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg. The recall, initiated by The Harvard Drug Group LLC, stems from microorganism detection on auxiliary polyester coil packaging, not the drug itself. This nationwide U.S. distribution disruption highlights critical packaging supplier oversight and quality control needs, impacting procurement and supply chain continuity for this essential antibiotic.

90-Day Activity
MKMeera Krishnan· Senior Regulatory Intelligence Analyst
2025-09-17