Dangerous black spots containing Aspergillus fungus have been found on widely used antibiotic tablets, prompting Amneal Pharmaceuticals to issue an urgent nationwide recall that could impact thousands of patients taking medication for common infections.
Key Takeaways
- Amneal Pharmaceuticals is recalling three lots of Sulfamethoxazole/Trimethoprim tablets (400mg/80mg) after black spots tested positive for potentially dangerous Aspergillus fungus
- The contaminated antibiotic tablets were distributed nationwide between December 4, 2024, and May 15, 2025, with all affected lots expiring in June 2027
- Aspergillus contamination poses serious infection risks, particularly for patients with compromised immune systems
- This recall is part of a concerning pattern, as Amneal has issued recalls for two other medications (ropivacaine and vancomycin) in recent months
Fungal Contamination Discovered in Critical Antibiotic
The Food and Drug Administration announced on June 4, 2025, that Amneal Pharmaceuticals has initiated a nationwide recall of three specific lots of Sulfamethoxazole/Trimethoprim tablets after identifying potentially dangerous fungal contamination. The recall affects only the 400mg/80mg strength tablets, which are commonly prescribed for urinary tract infections, bronchitis, ear infections, and travelers’ diarrhea. The contamination was discovered after a customer reported visible black spots on tablet surfaces, which subsequent testing confirmed contained Aspergillus fungus, a potential health hazard, particularly dangerous for people with weakened immune systems.
The affected lots are identified as Lot# AM241019, Lot# AM241019A, and Lot# AM241020, all carrying an expiration date of June 2027. These contaminated medications were distributed throughout the United States to wholesalers and distributors between December 4, 2024, and May 15, 2025. The recall specifically targets the 400 mg/80 mg strength tablets packaged in 100 and 500 tablet count bottles, leaving other strengths and formulations unaffected by this quality control failure.
Health Risks and Patient Response
Aspergillus contamination presents a significant health concern, as this fungus can cause severe infections in humans, particularly those with compromised immune systems. While the FDA announcement indicates that no adverse events, illnesses, or injuries have been reported as of the recall date, the potential for serious complications remains. Patients using these antibiotics are often already fighting bacterial infections, making them potentially more vulnerable to fungal complications. This situation highlights the ongoing quality control issues plaguing pharmaceutical manufacturing in America, where outsourced production and inadequate oversight continue threatening public health.
Patients currently taking Sulfamethoxazole/Trimethoprim tablets should check their medication against the recalled lot numbers and contact their healthcare providers immediately if they possess affected products. The recall is being conducted at the customer level, with notifications sent via UPS to wholesalers, distributors, and retailers who received the contaminated products. These businesses have been instructed to promptly inform their customers and provide detailed information about return procedures and reimbursement options.
Pattern of Quality Control Issues
This recall follows an alarming pattern of quality control failures at Amneal Pharmaceuticals in recent months. Just six weeks prior to this announcement, the company recalled two lots of ropivacaine hydrochloride injection due to potential contamination with inert fibers. Even more concerning, in March 2024, Amneal recalled four lots of generic vancomycin hydrochloride because of a manufacturing error that may have resulted in overfilled bottles. This series of recalls raises serious questions about the company’s manufacturing practices and quality assurance protocols during a time when American patients increasingly face medication shortages and quality concerns.
Consumers with questions regarding this recall can contact Amneal Pharmaceuticals directly at (833) 582-0812 or via email. Additionally, any adverse reactions should be reported to the FDA’s MedWatch Adverse Event Reporting program to ensure proper tracking of potential health impacts. This pattern of recalls underscores the urgent need for strengthened pharmaceutical manufacturing standards and increased domestic production of critical medications rather than relying on complex global supply chains with questionable quality control measures.
