FDA-Drug2026-10-23Class IIPROCESSING DEFECT
Hikma Abirtega abiraterone acetate 250 mg recalled for failed tablet weight uniformity
What this means
Hikma Pharmaceuticals is recalling Abirtega (abiraterone acetate) 250 mg tablets due to failed weight uniformity specifications. Lot 3047 (expiring July 2027) does not meet quality standards. The issue was identified during quality testing; no injuries have been reported.
- If you take Abirtega from lot 3047, contact your pharmacy or doctor before stopping or replacing your medication.
- Do not dispose of medication without guidance from a healthcare provider or pharmacy.
- Check your bottle label for lot number 3047 and expiration date July 2027.
The agency's original wording
Hazard
Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the United States
Affected count
2136 bottles
Manufactured in
1809 Wilson Rd, Columbus, Ohio, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0076-2027More Hikma Pharmaceuticals recalls
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.