Quality & complianceOfficial

FDA lists Class II recall of Glenmark abiraterone acetate 500 mg tablets over labelling issue

🇺🇸 FDA enforcement report · Wed 04 Nov 2026

Glenmark Pharmaceuticals Inc., USA is recalling Abiraterone Acetate Tablets USP 500 mg nationwide; the FDA enforcement report classifies the action as Class II and ongoing.

The US Food and Drug Administration has published a Class II drug recall for Abiraterone Acetate Tablets USP 500 mg in its enforcement report dated 4 November 2026. The recalling firm is Glenmark Pharmaceuticals Inc., USA.

The recall carries the number D-0074-2027. The FDA's record categorises the reason under labelling, specifically 'Not Elsewhere Classified', and does not describe the nature of the labelling problem in the material available.

The recall status is listed as ongoing. Distribution is nationwide within the United States.

The text available for this item consists largely of the FDA search-page interface and does not include details such as lot numbers, quantities, expiry dates or the date the firm initiated the recall. Companies and healthcare professionals should consult the full enforcement report entry for those particulars.

By way of context, the FDA assigns Class II to recalls where use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote.

What it means for your team

  • Regulatory and quality teams should check the full FDA enforcement report entry for D-0074-2027 to obtain lot and code details, which are not in the material reviewed.
  • Wholesalers, pharmacies and distributors holding Glenmark abiraterone 500 mg tablets in the US should verify whether their stock falls within the recall scope.
  • Because the recall is ongoing, the scope or status could be updated; teams tracking labelling-related recalls should monitor later enforcement reports.

Official source: FDA enforcement report ↗

Article written by VigiEye from the official source (FDA enforcement report). AI-assisted; check the source before acting.

More Quality & compliance All →