Voluntary nationwide recall: Sulfamethoxazole/Trimethoprim (Amneal – June)

Jun. 2025Pharmacy Updates

Amneal Pharmaceutical LLC is recalling certain lots of Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg. Sulfamethoxazole/Trimethoprim is used for the treatment of certain bacterial infections.

This drug is being recalled because tablets may have black spots due to microbial contamination. These black spots were reported during a product quality complaint. Using a drug that has microbial contamination may cause life-threatening illness. The use of the defective product in patients with underlying immunosuppressive conditions increases the concern for serious infections.

To see if your medication was recalled, contact your doctor or pharmacy where you received it or visit the FDA website below. If you have an affected lot of Sulfamethoxazole/Trimethoprim, you should stop using the product and return it to Amneal.

As of June 2, there had been no reports of adverse events related to this recall.

To learn more about this recall, you can take one or more of the steps below.

  • Talk to your doctor or pharmacist.
  • Call Amneal Pharmaceutical LLC at 833-582-0812. TTY users should call 711. Help is available Monday through Friday from 8 a.m. to 5 p.m. EST.
  • Visit the FDA website.

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