Hikma Recalls Abirtega Tablets for Weight Uniformity Failures
Hikma Pharmaceuticals is recalling Abirtega (abiraterone acetate) 250 mg tablets because they failed weight uniformity specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Class II due to tablets failing weight uniformity specifications, a defect that may cause temporary or medically reversible adverse health consequences. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Hikma Pharmaceuticals USA Inc. is recalling Abirtega (abiraterone acetate) USP, 250 mg, 120-count bottles. The recall involves 2,136 bottles of Lot 3047, which has an expiration date of July 2027. The product was distributed nationwide within the United States.
The recall was initiated because the tablets failed specifications for weight uniformity. This is a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote.
The source text does not report any illnesses, injuries, or deaths associated with this recall. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance on replacement or disposal.
The recalled product
- Product
- ABIRTEGA (ABIRATERONE ACETATE)
- Brand
- ABIRTEGA
- Manufacturer
- Hikma Pharmaceuticals USA INC.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 2,136
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 3047
- Exp Date July 2027.
UPCs (1)
- 0382249011123
Distribution
Distributed nationwide across the United States.
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