Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg

  • Microbial contamination
  • Company: Amneal Pharmaceutical LLC
  • Drugs
  • FDA
  • June 2, 2025

Product details

  • Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg

Company announcement

Amneal Pharmaceutical LLC is recalling Sulfamethoxazole/Trimethoprim Tablets due to microbial contamination.

The recalled product was distributed nationwide to wholesalers/distributors between December 4, 2024 to May 15, 2025.

No adverse events, illnesses or injuries related to this recall have been reported.

Risk:

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.

Impacted states: Nationwide

Products:

- Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg

- Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg

- Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg

Contact

For more information, call 1-833-582-0812 or email sulfamethoxazole-trimethoprim-recall@amneal.com.

View the original FDA notice

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