Hikma Pharmaceuticals USA INC. recalls Abirtega
- Recalling company
- 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 – may cause temporary or medically reversible health consequences
- Recall date
- Oct 6, 2026
- Reported
- Oct 28, 2026
- Distribution
- Nationwide within the United States
- Status
- Ongoing
- Quantity
- 2136 bottles
- Lot / codes
- Lot #: 3047, Exp Date July 2027.
- Company location
- Columbus, OH
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0076-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0076-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.