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Class II · ModerateActive recall

Abirtega

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 3047, Exp Date July 2027.
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byCivicaScript, LLC
Brand nameABIRTEGA
Generic nameABIRATERONE ACETATE
Active ingredient(s)ABIRATERONE ACETATE
Distributed by / forHikma Pharmaceuticals USA INC.
NDC82249-011-12
Show the full FDA record
Full product labelAbirtega (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.
Recalling firmHikma Pharmaceuticals USA INC.
DistributionNationwide within the United States
Quantity2136 bottles
Recall initiated2026-10-06
Report date2026-10-28
Recall completed—
Recall numberD-0076-2027
ClassificationClass II
FDA statusOngoing
Origin on fileColumbus OH United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.