Amneal Pharmaceuticals is recalling three lots of sulfamethoxazole/trimethoprim tablets because of microbial contamination that caused black spots to appear on the medication, according to a report from a customer.
The New Jersey-based generics manufacturer has issued a U.S. recall of three lots of the 400-mg/80-mg tablets that may be contaminated with Aspergillus, a fungus that can cause life-threatening infections, especially for those with underlying immunosuppressive conditions, the FDA said.
The recall is to the customer level, with notifications underway through UPS. The company has asked wholesalers, distributors and retailers to notify their customers of the recall and provide instructions on how to contact Amneal for the return of the products and for reimbursement information.
Amneal has not received any related reports of adverse events, injuries or illnesses, the FDA said.
The affected lots were shipped to distributors and wholesalers between Dec. 4, 2024, and May 15. All bottles have an expiration date of June 2027.
Sulfamethoxazole/trimethoprim is packaged in bottles that contain 100 or 500 tablets. Two of the lots were 100-tablet bottles. Those lot numbers are AM241019 and AM241020. The other lot is 500-tablet bottles, with the AM241019A identifier.
Sulfamethoxazole/trimethoprim is a combo medication commonly used for urinary tract infections. It is also used to treat middle ear infections, bronchitis, enteritis and traveler's diarrhea.
Twenty years ago, Amneal gained approval to produce the generic version of the combo, which was originally brought to the market by Roche as Bactrim in 1969.
The recall comes six weeks after Amneal recalled two lots of ropivacaine hydrochloride injection, with the warning that the anesthetic could contain inert “fibers” that leeched into the product from its IV bag, according to the FDA.
In March 2024, the company also recalled four lots of generic vancomycin hydrochloride after a manufacturing error may have resulted in overfilled bottles.