FDA recall, , Moderate risk
Hikma Abirtega (Abiraterone Acetate) Tablets
Abirtega (abiraterone acetate) USP tablets failed weight uniformity specifications.
Summary by Recall Canary from the FDA notice
What happened
Hikma Pharmaceuticals USA INC. recalled Abirtega (abiraterone acetate) USP, 250 mg, 120-count bottles, Rx only, because the tablets failed specifications for weight uniformity. The recall began October 6, 2026, and was added to the FDA's Enforcement Report on October 16, 2026, with FDA classification on October 23, 2026. The product, manufactured for Hikma by Arab Pharmaceuticals Manufacturing PSC, was distributed nationwide within the United States.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Abirtega (abiraterone acetate) USP
- NDC
- 82249-011-12
- Lot code
- 3047
Recall details
- Company began the recall
- Sold in
Nationwide within the United States
- Company
- Hikma Pharmaceuticals USA INC.
- Hazard
- Quality testing problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 100046
- Recall number
- D-0076-2027
- Quantity recalled
- 2136 bottles
All recalls from Hikma Pharmaceuticals USA INC.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
Classified by FDA
Summary updated
