FDA Announcement: Amneal Pharmaceutical LLC Recalls Sulfamethoxazole/Trimethoprim Tablets Due to Microbial Contamination

According to a June 4 announcement from the FDA, Amneal Pharmaceutical LLC has issued a voluntary recall of three specific lots of Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg due to microbial contamination. The recall was prompted by a product quality complaint reporting black spots on the tablet surface, which testing confirmed to be caused by the presence of microbial growth. The contaminant is suspected to be Aspergillus, a fungus that poses a significant risk of serious or life-threatening infections, particularly for immunocompromised individuals. As of now, no adverse health events related to the affected lots have been reported.

The recalled lots—AM241019, AM241019A, and AM241020—were distributed nationwide to wholesalers and distributors between December 4, 2024, and May 15, 2025. The affected tablets are used to treat a variety of bacterial infections including urinary tract infections, acute otitis media, chronic bronchitis exacerbations, enteritis, and traveler’s diarrhea. Only the 400 mg/80 mg strength in 100- and 500-count bottles from these specific lots is involved in the recall; no other products or lot numbers are affected.

Amneal is working with its distribution partners to arrange for the return and reimbursement of the recalled products. Wholesalers, retailers, and pharmacies are being instructed to notify customers and assist them with the return process. Consumers in possession of these products are advised to contact Amneal directly for support and to stop using the medication immediately.

Questions or concerns related to this recall can be directed to Amneal Pharmaceuticals through phone, fax, or email, and adverse events may also be reported to the FDA’s MedWatch program. This recall is being conducted in coordination with the U.S. Food and Drug Administration to ensure patient safety.