D-0076-2027 Class II Ongoing
FDA drug recall D-0076-2027 was initiated by Hikma Pharmaceuticals USA INC. on Oct 6, 2026 and is designated Class II. Reason for recall: Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity. The recall status is ongoing. Affected quantity: 2136 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Oct 28, 2026
- Initiation Date
- Oct 6, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2136 bottles
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.
Reason for recall
Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.
Distribution pattern
Nationwide within the United States
Code information
Lot #: 3047, Exp Date July 2027.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0076-2027
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026