The FDA enforcement report lists a Class II recall of Abirtega (abiraterone acetate) 250 mg tablets in 120-count bottles, manufactured for Hikma Pharmaceuticals USA. The stated reason is failed tablet specifications for weight uniformity. The recall is listed as ongoing.
A Class II recall means use of the product may cause temporary or medically reversible effects, or that serious harm is remote. Weight uniformity failures can mean individual tablets carry more or less drug than labelled. This is a manufacturing quality action on one product, not a new safety finding for abiraterone.
The notice covers a US-distributed product. Whether any related batches reached India is not stated, and no CDSCO action is known.
- Check whether patients on abiraterone 250 mg are taking the recalled US product
- Do not stop abiraterone because of this notice without an alternative supply
- Report unexpected changes in PSA control or side effects in patients on affected stock
- Confirm local supply with your pharmacy; no Indian action is known
Why it matters
Patients on long-term abiraterone need uninterrupted, correctly dosed supply.
Don't overread it
A tablet-weight recall is a manufacturing issue, not evidence that abiraterone is unsafe.
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