Amneal Pharmaceuticals Initiates Nationwide Recall of Contaminated Sulfamethoxazole/Trimethoprim Tablets

On June 1, Amneal Pharmaceuticals Inc. (NASDAQ:AMRX) initiated a nationwide recall of 3 specific lots of its Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg. This action was formally announced by the company on June 2 and subsequently published by the FDA on June 4. The reason for the recall comes from potential microbial contamination, which has led to the appearance of black spots on the tablet surface, which was a defect first reported in a product quality complaint.

A pharmaceutical laboratory filled with shelves of medicines, highlighting the company’s specialty drug production.

The affected product is typically sold in bottles containing either 100 or 500 tablets. The recall is strictly limited to the 400 mg/80 mg strength and specifically targets the following 3 lot numbers, all with an expiration date of June 2027 and first distributed on December 4, 2024: Lot Number AM241019 (NDC 65162-271-100, 100-count), Lot Number AM241019A (NDC 65162-271-500, 500-count), and Lot Number AM241020 (NDC 65162-271-100, 100-count). These recalled lots were distributed across the country to wholesalers and distributors between December 4, 2024, and May 15, 2025.

The primary concern with this microbial contamination, particularly if it involves Aspergillus, is the potential for serious and even life-threatening infections, especially in individuals with compromised immune systems. As of the recall announcement, Amneal Pharmaceuticals has not received any reports of adverse events, illnesses, or injuries directly linked to this issue. The tablets are prescribed for various bacterial infections, such as urinary tract infections, acute otitis media in children, acute exacerbations of chronic bronchitis, certain types of enteritis, and traveler’s diarrhea in adults. Amneal is in the process of notifying its customers, including wholesalers, distributors, and retailers, via UPS to facilitate the return of all recalled products.

Amneal Pharmaceuticals Inc. (NASDAQ:AMRX) is a global biopharmaceutical company that develops, manufactures, markets, and distributes generics, injectables, biosimilars, and specialty branded pharmaceutical products worldwide.

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Disclosure: None. This article is originally published at Insider Monkey.