OVERLOOKED

Recalls › Medicines & devices

Class IIOngoing

Hikma Pharmaceuticals USA INC. recalls Abirtega (abiraterone acetate) USP

Recall date · record updated Oct 28, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Hikma Pharmaceuticals USA INC.
Reason
Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
Nationwide within the United States
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=100046…

Products

  1. 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.

    Codes/lots: Lot #: 3047, Exp Date July 2027.Quantity: 2136 bottlesRecall no. D-0076-2027Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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