Abiraterone acetate Recall: Abirtega 250 mg 120-count bottles
Announced 2026-10-28 · FDA
FDA recall for Abirtega (abiraterone acetate) 250 mg, 120-count Rx bottles. Lot 3047, Exp July 2027. The issue is failed tablet specifications related to weight uniformity; 2136 bottles were distributed nationwide within the United States.
| Brand | Hikma Pharmaceuticals USA INC. |
|---|---|
| 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 | Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity. |
| Severity | moderate |
| Units affected | 2136 |
| Distribution | Nationwide within the United States |
| Agency | FDA |
WHAT YOU SHOULD DO
- Check your bottle for Lot 3047 and expiration date July 2027; stop using the product.
- Do not take this product; contact your pharmacist or prescriber for guidance and a substitute.
- Return the product to the place of purchase or follow the manufacturer's recall instructions; keep packaging for reference.
How to identify the recalled item
| Lot / date codes | Lot #: 3047, Exp Date July 2027. |
|---|---|
| Lot / date codes | Lot #: 3047, Exp Date July 2027. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other Hikma Pharmaceuticals USA INC. recalls
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.