Amneal Pharmaceuticals has recalled three lots of sulfamethoxazole and trimethropin tablets, USP, 400 mg/80 mg after reports of black spots on the tablets due to microbial contamination.
The contamination may contain the fungus Aspergillus, which can cause serious infections, particularly in people with weakened immune systems, according to a June 4 news release from the FDA. The tablets are used to treat various bacterial infections, including urinary tract infections and bronchitis.
The affected lots, AM241019, AM241019A and AM241020, were distributed nationwide between December 4, 2024, and May 15. The recall impacts only the 400 mg/80 mg strength tablets sold in 100-count and 500-count bottles.
No illnesses or injuries have been reported.
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