Hikma Pharmaceuticals USA Inc.: Abirtega (abiraterone Acetate) Usp, 250 Mg, 120-count Bottles
Hikma Pharmaceuticals is recalling Abirtega (abiraterone acetate) 250 mg tablets in 120-count bottles nationwide because the tablets don't meet weight uniformity specifications. This is a prescription medication used to treat prostate cancer, and the recall affects all U.S. states and territories. The issue is classified as a Class II recall, meaning there is potential for adverse health effects.
- Recalling firm
- Hikma Pharmaceuticals USA INC.
- Product
- 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.
- Reason
- Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-10-06
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within the United States
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/4b68d9f8-5811-49da-a425-c4cfe34cb5a3