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# Amneal Recalls Contaminated Tablets
- URL: https://www.fdaweb.com/amneal-recalls-contaminated-tablets/
- Published: 2025-06-06T12:00:00.000Z
- Updated: 2026-09-14T15:13:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159315

Amneal Pharmaceutical is recalling (Class 1) three lots of sulfamethoxazole/trimethoprim tablets because they may exhibit black spots on their tablet surface due to microbial contamination. “Oral products contaminated with *Aspergillus* may result in serious and life-threatening infections,” a [recall notice](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceutical-llc-issues-nationwide-recall-sulfamethoxazole-trimethoprim-tablets-usp-400?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. “The use of the defective product in patients with underlying immunosuppressive conditions increases the concern for serious infections. To date, Amneal Pharmaceuticals has received no reports of adverse events, illnesses or injuries related to this recall." 

The product is indicated for treating urinary tract infections caused by susceptible strains of the following organisms: *Escherichia Coli*, *Klebsiella* species, *Enterobacter* species, *Morganella morganii*, *Proteus mirabilis* and *Proteus vulgaris*.