"FDA Warns of Nationwide Recall of Popular Antibiotic"

A Common Antibiotic Recall Nationwide

Dealing with a urinary tract infection is a common issue for many people. According to the Cleveland Clinic, between 8 and 10 million Americans seek medical treatment for UTIs each year. While there are some home remedies that can be helpful in the early stages, antibiotics are often necessary once a UTI sets in. However, the U.S. Food and Drug Administration (FDA) has issued a warning regarding a popular antibiotic that may be contaminated.

Concerns with Sulfamethoxazole/Trimethoprim Tablets

The FDA recently notified the public about a recall of three lots of Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg, by Amneal Pharmaceutical LLC due to microbial contamination. These tablets are commonly used for treating UTIs, ear infections in children, traveler's diarrhea, and other conditions.

The agency stated that tablets from the affected lots may have black spots on the surface due to the contamination. This contamination could involve Aspergillus, a type of fungi, which poses a risk of serious and life-threatening infections, especially in individuals with weakened immune systems.

Recalled Product Details

The affected tablets were distributed to wholesalers and distributors nationwide between December 4, 2024, and May 15, 2025. The specific details of the recalled product include lot numbers, expiration dates, and bottle pack sizes. The FDA advises individuals to check the lot numbers on the product label or consult their pharmacy for more information.

Recall Process and Safety Measures

Amneal Pharmaceutical LLC has issued a press release on its website regarding the recall and has initiated the process of contacting customers to return the recalled product. Wholesalers and distributors have also been instructed to provide guidance on returning the affected tablets.

As of the FDA's report, there have been no reported illnesses or adverse events related to the recalled antibiotic. However, individuals are encouraged to report any adverse events and contact Amneal with any concerns.

Stay Informed and Follow Safety Guidelines

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It's crucial to prioritize your health and take precautions when it comes to medication safety. Be proactive in checking for product recalls and follow the guidance provided by regulatory agencies and pharmaceutical companies to ensure your health and safety.