Abirtega Recalled Over Tablet Weight Uniformity

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for Abirtega (abiraterone acetate) USP, 250 mg. The affected batch has been identified as Lot 3047 (expires July 2027), containing 2136 bottles.
• The recall was initiated by Hikma Pharmaceuticals USA, Inc due to the product’s failure to meet tablet specifications, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• Abiraterone acetate is used to treat prostate cancer.

The FDA has issued a Class II recall for Abirtega (abiraterone acetate) USP, 250 mg, affecting 2136 bottles. This product is manufactured by Arab Pharmaceuticals Manufacturing and is being recalled by Hikma Pharmaceuticals USA, Inc based in Columbus, Ohio. The recall was initiated on October 6, 2026, and received a Class II classification on October 23, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated after the product failed to meet tablet specifications for weight uniformity. This issue affects Lot 3047, which will expire in July 2027. Hikma Pharmaceuticals sent out a public notice via letter; no press release was issued for this recall.

Abiraterone acetate is used in combination with prednisone to treat metastatic castration-resistant prostate cancer and metastatic high-risk castration-sensitive prostate cancer. Pharmacists should identify and quarantine Lot 3047, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. October 28, 2026. Accessed October 28, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=223192