Amneal Pharmaceuticals is recalling three lots of Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg due to potential microbial contamination indicated by black spots on the tablet surface. The affected lots (AM241019, AM241019A, AM241020) were distributed nationwide between December 4, 2024, and May 15, 2025, in 100- and 500-count bottles.

The contamination, potentially Aspergillus, poses a risk of serious infections, especially in immunocompromised patients, though no adverse events have been reported. The tablets treat urinary tract infections, acute otitis media, chronic bronchitis exacerbations, enteritis, and traveler’s diarrhea.

Amneal is coordinating returns and notifying customers. Consumers can contact Amneal at 833-582-0812, [email protected], or fax 631-983-2595 for assistance.

Adverse reactions can be reported to Amneal Drug Safety at 1-877-835-5472 or [email protected], or to the FDA’s MedWatch program.

The recall is conducted with FDA oversight.