The observance of black spots was reported in a product quality complaint, the U.S. FDA said, while noting that oral products contaminated with Aspergillus may result in serious and life-threatening infections.

Amneal Pharmaceuticals (AMRX) is recalling multiple lots of its urinary tract infection (UTI) medication as the tablets may exhibit black spots on their surface, the U.S. Food and Drug Administration (FDA) announced on Wednesday.

The recall includes three lots of Sulfamethoxazole/Trimethoprim tablets, USP, 400 mg/80 mg. The lots may develop black spots due to microbial contamination.

The observance of black spots was reported in a product quality complaint, the regulator said, while noting that 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, it added. However, to date, Amneal Pharmaceuticals has received no reports of adverse events, illnesses, or injuries related to the recall.

The recalled product was distributed nationwide to wholesalers or distributors between December 2024 and May 2025.

The recall, however, pertains only to the 400 mg/80 mg strength and affects only three lots.

Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg are packaged in 100 tablet count and 500 tablet count bottles. In addition to treatment for UTIs, the drug is also used for treating chronic bronchitis, enteritis, and traveler’s diarrhea. It is also used to treat acute otitis media in pediatric patients.

On Stocktwits, retail sentiment around Amneal stayed unmoved within ‘bearish’ territory over the past 24 hours while message volume stayed at normal levels.

AMRX's Sentiment Meter and Message Volume as of 1:00 p.m. ET on June 4, 2025 | Source: Stocktwits

AMRX is down by about 1% at noon on Wednesday. The stock is down approximately 5% this year and up about 10% over the past 12 months.

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