October 2026 FDA Recall Abirtega by Hikma Pharmaceuticals Usa Inc.
D-0076-2027 - Failed Tablet/Capsule Specifications

This Class II drug recall was voluntarily initiated by Hikma Pharmaceuticals Usa Inc. on October 6, 2026 for the product Abirtega. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0076-2027

Reason for Recall
Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.
Initiated
10-06-2026
Reported
10-28-2026
Quantity
2136 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
100046
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hikma Pharmaceuticals USA INC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# : 3047, Exp Date July 2027.

Affected Packages Involved in this Recall

82249-011-12 Abirtega