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Home › FDA recalls › Abiraterone Acetate Tablets USP 500 mg
CLASS II · ModerateFDA

Glenmark Pharmaceuticals Inc., USA recalls Abiraterone Acetate Tablets USP 500 mg

📅 Oct 9, 2026 · 📍 Nationwide
Recalling company
Glenmark Pharmaceuticals Inc., USA
Product
Abiraterone Acetate Tablets USP 500 mg, 60-count bottles, Rx only, Distributed by: Glenmark Pharmaceuticals USA, Elmwood Park, NJ 07407, NDC 68462-882-60
Reason
Labeling: Not Elsewhere Classified
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Oct 9, 2026
Reported
Nov 4, 2026
Distribution
Nationwide within the United States
Status
Ongoing
Quantity
1296 bottles
Lot / codes
Lot #: 13250135, Exp. Date 11/2027
Company location
Elmwood Park, NJ
Recall type
Voluntary: Firm initiated
Recall number
D-0074-2027
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0074-2027 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.