Abirtega (abiraterone acetate) USP, 250 mg, 120-count… was recalled on October 6, 2026 in cooperation with the U.S. Food and Drug Administration because failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity..
Abirtega (abiraterone acetate) USP, 250 mg, 120-count bottles, Rx only, Rx only, Mfd for: Hikma Pharmaceuticals USA Inc., Berkley Heights, NJ 07922 USA by: Arab Pharmaceuticals Manufacturing PSC PO Box 41, Sahab-Jordon, NDC 82249-011-12.
Lot #: 3047, Exp Date July 2027.
Units affected: 2136 bottles
Where it was sold: Nationwide within the United States
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Hikma Pharmaceuticals USA INC.
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.
Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.
Lack of sterility assurance.
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