FDA

Amneal recalls sulfamethoxazole/trimethoprim 400 mg/80 mg tablets due to microbial contamination

June 6, 2025

Amneal Pharmaceutical LLC issued a voluntary nationwide recall of three lots of Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg, due to microbial contamination. The affected tablets, distributed between December 4, 2024, and May 15, 2025, may exhibit black spots on the surface, which were identified in a product quality complaint. Lab analysis confirmed the presence of microbial contamination, potentially Aspergillus species, which poses a serious risk, particularly to immunocompromised patients.

The recall affects only the 400 mg/80 mg strength in 100- and 500-count bottles, specifically lots AM241019, AM241019A, and AM241020. No other strengths or lots are impacted. While no adverse events have been reported to date, FDA warns that oral ingestion of contaminated tablets could lead to life-threatening infections. HCPs are advised to check inventory and quarantine affected lots immediately.

Source:

(2025, June 4). FDA. Amneal Pharmaceutical LLC Issues a Nationwide Recall of Sulfamethoxazole / Trimethoprim Tablets, USP, 400 mg/80 mg Only, Due to Microbial Contamination [Company Announcement]. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceutical-llc-issues-nationwide-recall-sulfamethoxazole-trimethoprim-tablets-usp-400