A Common Antibiotic Has Been Recalled Nationwide

It’s a creeping feeling some of us are all too familiar with: an impending urinary tract infection. While there are some home remedies to try if you catch it early—cranberry juice, anyone?—between 8 and 10 million Americans seek medical treatment for urinary tract infections (often called UTIs) every year, according to the Cleveland Clinic.

Though urinary tract infections are particularly common in women—the Cleveland Clinic says about half of all women will experience one at some point in their lives—men and children can also get them. Antibiotics are a frequent course of action once a UTI sets in, but the U.S. Food and Drug Administration (FDA) is warning that one popular option could have “microbial contamination.”

On Wednesday, June 4, the agency alerted the public about the risk, saying three lots of the drug Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg, have been recalled nationwide by Amneal Pharmaceutical LLC.

The FDA’s notice says the medication is used for the treatment of UTIs, acute otitis media (middle ear infections) in pediatric patients, traveler’s diarrhea, and several other conditions.

The recall is due to tablets that “may exhibit black spots on the tablet surface due to microbial contamination,” says the FDA. The agency goes on to say the “observance of black spots” was logged in a product quality complaint.

The report seems to indicate that the products could be contaminated with Aspergillus, a type of fungi. The FDA included the following risk statement: “Oral products contaminated with Aspergillus may result in serious and life-threatening infections. The use of the defective product in patients with underlying immunosuppressive conditions increases the concern for serious infections.”

The affected products were reportedly distributed to wholesalers and distributors across the country between December 4, 2024, and May 15, 2025.

The product details are:

Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg

• Lot Number: AM241019, NDC (National Drug Code) Number: 65162-271-10, Expiration Date: 06/2027, Date of First Distribution: 12/4/2024, Bottle Pack Size: 100 count
• Lot Number: AM241019A, NDC Number: 65162-271-50, Expiration Date: 06/2027, Date of First Distribution: 12/4/2024, Bottle Pack Size: 500 count
• Lot Number: AM241020, NDC Number: 65162-271-10, Expiration Date: 06/2027, Date of First Distribution: 12/4/2024, Bottle Pack Size: 100 count

The FDA advises that the recall only includes the listed lot numbers at the 400 mg/80 mg strength. Lot numbers can be found on the bottle label or by consulting a pharmacy if you received a pharmacy vial, per the report.

Amneal Pharmaceutical LLC has also posted a press release about the recall on its website, which includes product label photos.

Neither the FDA nor Amneal listed how many individual bottles of the antibiotic have been recalled as a result.

Amneal is contacting its customers and arranging for the recalled product to be returned. Meanwhile, wholesalers and distributors have been asked to contact their customers and provide information for returning the product.

As of the FDA’s report last week, no illnesses, injuries, or adverse events have been connected to the recall. However, information about reporting any adverse events is provided at the above FDA link, along with details for contacting Amneal with any questions.

For daily wellness updates, subscribe to The Healthy by Reader’s Digest newsletter and follow The Healthy on Facebook and Instagram. Keep reading:

• More Than 732,000 Bottles of a Blood Pressure Medication Were Just Recalled Nationwide
• 1,350 Cases of Oatmeal Have Been Recalled in 4 States and Washington, D.C.
• More Than 9,000 Bottles of a Pain Reliever Have Been Recalled Nationwide
• Ground Beef Sold in at Least 26 States Has Triggered a Public Health Alert