Urinary tract infection drug recalled

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 appearance 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 in children; streptococcus pneumoniae aka pneumococcus, which the Cleveland Clinic says can cause pneumonia, sepsis or bacterial meningitis; and “traveler’s diarrhea.”

Recalled tablets with 400 mg of Sulfamethoxazole and 80 mg Trimethoprim went to wholesalers and distributors around the nation from Dec. 4 through May 15. If you have these tablets but got them before Dec. 4, you’re safe.

2025 Miami Herald. Distributed by Tribune Content Agency, LLC.

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 appearance 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 in children; streptococcus pneumoniae aka pneumococcus, which the Cleveland Clinic says can cause pneumonia, sepsis or bacterial meningitis; and “traveler’s diarrhea.”

Recalled tablets with 400 mg of Sulfamethoxazole and 80 mg Trimethoprim went to wholesalers and distributors around the nation from Dec. 4 through May 15. If you have these tablets but got them before Dec. 4, you’re safe.

2025 Miami Herald. Distributed by Tribune Content Agency, LLC.