It's not the first time this year the popular drug's manufacturer has faced issues. Check to see if your prescription is affected.
Every year, doctors in America dole out around 236 million prescriptions for antibiotics in outpatient settings, according to 2022 data from health experts. And if you’ve recently had to fill a prescription, perhaps for a pesky UTI or ear infection, it’s time to scan the shelves of your medicine cabinet for a popular drug duo that’s now sparked a nationwide recall.
According to a September 4 announcement by the U.S. Food and Drug Administration (FDA), Amneal Pharmaceuticals, LLC, a Bridgewater, NJ-based firm, has recalled a total of 133,126 bottles of Sulfamethoxazole and Trimethoprim Tablets. The Mayo Clinic says these pills are typically prescribed for urinary tract infections, but are also sometimes used to treat respiratory infections including pneumonia, ear infections, and more. The tablets are available as a generic drug under brand names such as Bactrim, Septra, and Sulfatrim.
First initiated on August 18, the recall reportedly went into effect after microbial contamination was discovered on a “polyester coil” used in the product’s packaging. The recall notice does not specify what foreign substance was discovered, but notes that it was not detected on any tablets. In the same notice, the FDA warned that over 33,000 bottles of an antipsychotic medication known as chlorproMAZINE Hydrochloride Tablets were recalled for the same reason.
The affected pills were produced by Amneal Pharmaceuticals in Ahmedabad, India, and were distributed in 800mg (Sulfamethoxazole) and 160mg (Trimethoprim) double-strength doses. In total, 60,072 100-count bottles and 73,054 500-count bottles were included in the recall. The FDA provided the following codes and expiration dates:
Lot A
- AM240173, Exp. Date 01/31/2027
- AM240680, Exp. Date 05/31/2027
- AM 240921, Exp. Date 06/30/2027
- AM241191, Exp. Date 08/31/2027
Lot B
- AM240176, AM240177, Exp. Date 01/31/2027
- AM240301, AM240300, Exp. Date 02/28/2027
- AM240676, AM240677, Exp. Date 04/30/2027
- AM240678, AM240679, Exp. Date 05/30/2027
- AM240922, AM240923, AM240924, AM240925, Exp. Date 6/30/27
- AM241086, Exp. Date 7/31/27
- AM241087, AM241088, Exp. Date 8/31/27
In the September 4 notice, the FDA says the incident is now considered a Class II recall, meaning that taking the pills could cause temporary illness or harm, but are unlikely to lead to more serious complications or fatalities.
Sulfamethoxazole and Trimethoprim are two antibiotics that are frequently combined to prevent bacterial growth. They work by blocking two steps in the bacteria’s process of creating and synthesizing folic acid, which is essential for bacterial development and survival, studies say.
Previously, Amneal Pharmaceuticals announced in June a recall of 400 mg/80 mg doses of the same drugs at the consumer level after black spots suggesting microbial contamination were discovered on the product. According to an FDA press release, the spots were determined to be Aspergillosis, a type of mold (fungus) which “may result in serious and life-threatening infections,” especially in immune-compromised individuals.
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