Regulatory UpdatesAug 24, 2026•1 min read

FDA Recall: CGMP Deviations Due to Intermittent Temperature Excursions

By the PharmaCountry team

The FDA has issued a recall citing CGMP deviations caused by intermittent temperature excursions during storage.

The U.S. Food and Drug Administration has initiated a recall after identifying current Good Manufacturing Practice (CGMP) deviations. The specific issue involved intermittent exposure to temperature excursions during product storage, which may affect product quality and safety. Manufacturers are advised to assess affected batches and implement corrective actions to prevent future occurrences.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#recall #CGMP #temperature excursion #storage #FDA #quality