Regulatory UpdatesAug 25, 2026•1 min read

FDA Recalls Drug Over Adulterated API and Content Uniformity Failure

By the PharmaCountry team

The FDA has recalled a product after discovering an adulterated active ingredient and insufficient manufacturing controls that caused content uniformity failures.

The FDA issued a recall for a pharmaceutical product after determining that the active pharmaceutical ingredient (API) used was adulterated. In addition, the manufacturing process lacked adequate controls and good manufacturing practices, leading to the finished product failing content uniformity specifications. Such failures can result in doses that are stronger or weaker than labeled, posing potential safety risks to patients.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#recall #adulterated API #content uniformity #GMP #FDA #pharmaceutical manufacturing