Abirtega (abiraterone acetate) USP, 250 mg, 120-count bottles, Rx only, Rx only, Mfd for: Hikma Pharmaceuticals USA Inc.
Summary
The FDA issued a Class II for Abirtega (abiraterone acetate) USP, 250 mg, 120-count bottles, Rx only, Rx only, by Hikma Pharmaceuticals USA INC.. Reason: Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity..
Details
Source
Drug Recall
External ID
D-0076-2027
Action Date
2026-10-28
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: Lot #: 3047, Exp Date July 2027.
Quantity Affected: 2136 bottles
Reason for Recall
Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2026-10-06
Company
Columbus, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 34 drug recalls issued in the same week, part of 76 drug-related FDA actions this month.
Hikma Pharmaceuticals USA INC. has 12 FDA actions in our database, including 12 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hikma Pharmaceuticals USA INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hikma Pharmaceuticals USA INC. have FDA actions?
Hikma Pharmaceuticals USA INC. has 12 FDA actions in our database, including 12 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0076-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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