Hikma recalls Abirtega (abiraterone acetate) 250 mg tablets over failed weight uniformity check
The recalled 120-count bottles of Abirtega (abiraterone acetate) USP, 250 mg, failed tablet specifications for weight uniformity, and 2136 bottles were sent out nationwide within the United States.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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.
- Hazard
- Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.
- Units
- 2136 bottles
- Where sold
- Nationwide within the United States
- FDA classification
- Class II · Ongoing
- Classified by FDA
- October 23, 2026
- Recall started
- October 6, 2026
- FDA enforcement report
- October 28, 2026
- Identifiers
- Codes: Lot #: 3047, Exp Date July 2027.
- FDA recall number: D-0076-2027
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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.
- Reason for recall
- Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.
- Classification
- Class II (Ongoing)
- Distribution
- Nationwide within the United States
- Quantity
- 2136 bottles
Related recalls
Hikma recalls Ramipril 10 mg capsules because of too much of a manufacturing impurity
Testing found a process impurity called dicyclohexylurea (DCU) at a level outside the allowed limit in these ramipril capsules, so they failed purity standards.
Hikma Pharmaceuticals USA INC. · 25,970 units
Hikma recalls Alendronate Sodium Oral Solution over out-of-specification test results in some bottles
A limited number of bottles of Alendronate Sodium Oral Solution that were stored on their side had assay test results that were out of specification.
Hikma Pharmaceuticals USA INC · 4 single dose 75 ml bottles
Greenwich Rx recalls Glutathione Injection 10 mL vials over microbial contamination
The notice says the sterile Glutathione Injection (200 mg/mL, 10 mL multi-dose vial, Subcutaneous Only) has microbial contamination, and 4,319 vials were sent across the US.
Greenwich Rx · 4,319 vials
Pritam International recalls Brush Buddies and evo toothpastes over manufacturing practice problems
The notice says these anticavity fluoride toothpastes were made with deviations from current good manufacturing practices and were distributed across the US.
Pritam International Private Limited · 3,309,696 units
Strides Pharma recalls Cinacalcet Tablets 30 mg because they failed dissolution specifications
The 30 mg Cinacalcet Tablets in 30-count bottles failed dissolution specifications, and 49,488 bottles were distributed across the US.
Strides Pharma INC · 49,488 30-count bottles
Viatris recalls telmisartan and amlodipine tablets because telmisartan content may be too high
The tablets may contain more telmisartan than they are supposed to, so the content in these lots could go over the limit set for the product.
Viatris, Inc. · 21,620 30-count bottles