Glenmark's US abiraterone 500 mg tablets drawn into FDA Class II recall

Glenmark Pharmaceuticals Inc., USA has a live recall on its abiraterone acetate 500 mg tablets across the United States, according to the FDA's enforcement report published on 4 November 2026. The agency filed it under number D-0074-2027 and rated it Class II.

The regulator attributes the action to a labelling problem, filed in its catch-all category of 'Not Elsewhere Classified'. The material reviewed does not explain what was wrong with the labelling. It also omits lot numbers, the volume of product involved, expiry dates and the date Glenmark began the recall.

For context, the FDA uses Class II for recalls where exposure to a product may cause temporary or medically reversible harm, or where the chance of serious harm is considered remote. That is a general definition of the category, not a finding specific to this product.

Because the recall is listed as ongoing, its scope and status may change in later enforcement reports. Without figures on affected units, the facts on file do not allow any assessment of lost sales, supply disruption or effects on competitors in the abiraterone generics market, and Glenmark has not been quoted in the material available.