Abirtega USP 250 mg Recall
Abirtega (abiraterone acetate) USP, 250 mg, 120-count bottles, Rx only, Rx only, Mfd for: Hikma Pharmaceuticals USA Inc., Berkley Heights, NJ 07922…
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Abirtega USP 250 mg recalled?
Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full 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.
Which lot codes, UPCs or models are affected?
Lot #: 3047, Exp Date July 2027.
- Agency record number
- D-0076-2027
- Product
- Abirtega (abiraterone acetate) USP, 250 mg, 120-count bottles, Rx only, Rx only, Mfd for: Hikma Pharmaceuticals USA Inc., Berkley Heights, NJ 07922…
- Recalling firm
- Hikma Pharmaceuticals USA INC.
- Quantity
- 2136 bottles
- Distribution
- Nationwide within the United States
- Recall started
- October 6, 2026
- Report date
- October 28, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)