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Abirtega USP, 250 mg, 120-count bottles, Rx only, Rx only, Mfd for Hikma Recall 2026

ABIRTEGAIssued October 6, 2026Updated Reviewed by the Recall Watch editorial team

ABIRTEGA 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 Bo — recalled per FDA on 10/6/2026. Reason: Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity..

Agency
FDA
Issued
Oct 6, 2026
Brand
ABIRTEGA
Distribution
1 states
Lots affected
2
What to do right now

Steps to take for this recall

  1. Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

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Verified summary of the official U.S. Food and Drug Administration notice · Issued October 6, 2026 · Last synced Nov 2, 2026

What's recalled

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.

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Why it was recalled

Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.

Affected products & lot numbers
2 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
Lot #: 3047
Exp Date July 2027.
Where was it sold
1 state

Nationwide within the United States

nationwide
Official noticefda.gov
More recalls like this
4 related — by brand, contaminant, and category

Frequently asked questions

Is the ABIRTEGA recall still active?

Yes, this recall is currently active as of October 6, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot #: 3047, Exp Date July 2027.. Check the label on your product.

What should I do if I have the recalled ABIRTEGA?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.