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.