Three lots of a drug designed to treat various urinary tract infections have been recalled because the white round tablets might have black spots from microbial contamination.

The spotting of spots “was reported in a product quality complaint,” Amneal Pharmaceuticals said in its FDA-posted recall notice about Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg.

As for what problems this might cause, Amneal’s notice said: “Oral products contaminated with Aspergillus may result in serious and life-threatening infections. The use of the defective product in patients with underlying immunosuppressive conditions increases the concern for serious infections.”

Sulfamethoxazole/Trimethoprim is used for UTIs caused by a broad list of strains, among which are E. coli; middle-ear infections i

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