Amneal Pharmaceutical LLC has initiated a nationwide recall of three lots of Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg. The recall is due to microbial contamination, as black spots were observed on the tablet surface in a product quality complaint.
According to Amneal Pharmaceuticals, "Oral products contaminated with Aspergillus may result in serious and life-threatening infections." They also noted that there have been no reports of adverse events or illnesses related to this recall so far.
The affected product was distributed across the United States to wholesalers and distributors between December 4, 2024, and May 15, 2025. This medication is used for treating urinary tract infections caused by specific organisms such as Escherichia Coli and Klebsiella species, among others. It is also indicated for acute otitis media in pediatric patients and acute exacerbations of chronic bronchitis due to Streptococcus pneumoniae.
The recalled tablets are available in bottles containing either 100 or 500 tablets. Only the specified lots of the 400 mg/80 mg strength are included in this recall. Customers can identify the lot number on the Amneal bottle label or consult their pharmacy if they received a pharmacy vial.
Amneal is notifying customers via UPS about the recall and arranging for returns. Wholesalers and distributors are instructed to inform their customers about the recall process. Retailers should notify consumers and provide guidance on contacting Amneal for assistance with returns and reimbursement information.
For questions regarding this recall, individuals can contact Amneal Pharmaceuticals by phone at 833-582-0812 during business hours or via email at sulfamethoxazole-trimethoprim-recall@amneal.com. Medical inquiries or reports of adverse events can be directed to Amneal Drug Safety at 1-877-835-5472 or DrugSafety@amneal.com.
Adverse reactions or quality issues experienced with this product can also be reported to the FDA's MedWatch Adverse Event Reporting program online or by mail/fax using a downloadable form from their website.
This recall is being conducted with oversight from the U.S. Food and Drug Administration.
