Abirtega recall (Hikma Pharmaceuticals USA INC.)
DrugClass IIOngoing
Summary: Hikma Pharmaceuticals USA INC. is recalling 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.
What is being recalled
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.
Why
Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide within the United States
How to tell if yours is affected
Lot #: 3047, Exp Date July 2027.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0076-2027 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | October 6, 2026 |
| Reported | October 28, 2026 |
| Company | Hikma Pharmaceuticals USA INC. |
| Company location | Columbus, OH, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 2136 bottles |
More recalls from Hikma Pharmaceuticals USA INC. · all drug recalls · recalls from October 2026