CLASS II ONGOING Drug recall · Reported 28 Oct 2026 · FDA Enforcement Report
Abirtega (abiraterone acetate) USP, 250 mg recalled
Hikma Pharmaceuticals USA is recalling Abirtega (abiraterone acetate) USP, 250 mg, distributed nationwide in the US. The recall was initiated on 6 Oct 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0076-2027
- FDA event ID
- 100046
- Recalling firm
- Hikma Pharmaceuticals USA, Columbus, OH
- Brand
- Abirtega
- Manufacturer
- CivicaScript, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Oct 2026
- FDA classified
- 23 Oct 2026
- Reported
- 28 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 6 Oct 2026 | Recall initiated by company | |
| 23 Oct 2026 | Classified by FDA | +17 days |
| 28 Oct 2026 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.
Product as listed by the FDA
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.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.
Which lots are affected?
Lot #: 3047, Exp Date July 2027.
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 3 Nov 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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