Black mold contamination found on critical antibiotic tablets has triggered a nationwide recall, putting vulnerable patients at risk of severe fungal infections from medication designed to treat their bacterial illnesses.
Key Takeaways
- Amneal Pharmaceuticals is recalling three lots of Sulfamethoxazole/Trimethoprim tablets due to Aspergillus fungus contamination, identified as black spots on the tablets
- The affected antibiotic, commonly used to treat urinary tract infections and other bacterial infections, was distributed nationwide between December 2024 and May 2025
- Contaminated medications pose serious health risks, particularly for immunocompromised patients who are more susceptible to fungal infections
- This recall is part of a concerning pattern, as Amneal has recalled multiple medications in recent months, including ropivacaine and vancomycin
Dangerous Fungal Contamination Discovered
Amneal Pharmaceuticals has initiated an urgent nationwide recall of three lots of Sulfamethoxazole/Trimethoprim tablets after discovering black spots on the medication’s surface that tested positive for Aspergillus fungus. The contamination affects only the 400mg/80mg strength tablets with lot numbers AM241019, AM241019A, and AM241020, all bearing an expiration date of June 2027. These potentially dangerous medications were distributed to wholesalers and retailers across the country between December 4, 2024, and May 15, 2025, creating a widespread risk to patients who may have received the contaminated antibiotics.
The contamination is particularly concerning because Aspergillus can cause severe and even life-threatening infections, especially in people with weakened immune systems. Sulfamethoxazole/Trimethoprim is an antibiotic commonly prescribed to treat urinary tract infections, bronchitis, certain types of diarrhea, and ear infections in children. The medication is available in both 100 and 500 tablet count bottles, all of which are included in this recall if they match the affected lot numbers. While no adverse health effects have been reported yet, the potential for serious harm has prompted swift action from both the company and the FDA.
Pattern of Quality Control Issues
This recall is not an isolated incident for Amneal Pharmaceuticals, raising serious questions about quality control measures at the company’s manufacturing facilities. Just six weeks earlier, Amneal recalled two lots of ropivacaine hydrochloride injection due to potential contamination with inert fibers. In March 2024, the company also recalled four lots of generic vancomycin hydrochloride because of a manufacturing error that may have caused overfilled bottles. This pattern of recalls within a short timeframe suggests systemic problems that could be putting American patients at risk.
The FDA announced the latest recall on June 4, 2025, after Amneal initiated the action two days earlier. The recall is classified as customer-level, meaning wholesalers, distributors, and retailers who received the affected products have been notified via UPS and instructed to immediately inform their customers. This process ensures that potentially contaminated tablets are removed from circulation before they can cause harm to unsuspecting patients who might otherwise continue taking their prescribed medication without knowledge of the contamination.
What Patients Should Do
Patients who may have received the affected medication should check their prescription bottles for the lot numbers AM241019, AM241019A, or AM241020, and contact their healthcare provider immediately if they have the recalled product. Consumers can also contact Amneal Pharmaceuticals directly with questions or concerns at (833) 582-0812 or via email. The company has established procedures for returns and reimbursement to ensure that patients are not left without their necessary medication or financially burdened by the recall.
Healthcare providers and patients who experience adverse reactions or quality problems with the medication should report them to the FDA’s MedWatch Adverse Event Reporting program. This reporting system helps the FDA monitor the safety of pharmaceutical products and take appropriate action when problems arise. As this recall continues to unfold, it serves as a critical reminder of the importance of robust quality control measures in pharmaceutical manufacturing to protect American patients from potentially dangerous contamination issues that compromise their health and safety.
