Quality & complianceOfficial

Hikma recalls Abirtega abiraterone tablets in US over failed weight uniformity specification

🇺🇸 FDA enforcement report · Wed 28 Oct 2026

FDA's enforcement report lists a Class II recall of Hikma's Abirtega (abiraterone acetate) USP, with distribution nationwide and the recall still ongoing.

The US Food and Drug Administration has listed a Class II drug recall of Abirtega (abiraterone acetate) USP, a product of Hikma Pharmaceuticals USA Inc., in its enforcement report dated 28 October 2026.

The recall, numbered D-0076-2027, concerns failed tablet or capsule specifications. According to the entry, the tablets failed specifications for weight uniformity.

The product was distributed nationwide within the United States. The recall's status is shown as ongoing.

The page text available for this report contained only search-tool and navigation content. It did not include batch or lot details, quantities, recall initiation dates or the strengths affected, so those points cannot be reported here.

For context, 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

  • Quality teams should note that weight uniformity failures in solid oral dosage forms can trigger market action even when classified Class II.
  • Regulatory and supply-chain teams handling abiraterone products in the US should check the full enforcement report entry for lot-level details, which were not available in the source reviewed.
  • Because the recall is ongoing, further updates to its status or scope may appear in 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.

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