FDA-Drug2026-10-23Class IIMISBRANDING
Glenmark Abiraterone Acetate 500 mg tablets recalled for labeling defect
What this means
Glenmark Pharmaceuticals is recalling Abiraterone Acetate Tablets USP 500 mg in 60-count bottles due to a labeling defect. The affected lot (13250135, expiring 11/2027) was distributed nationwide. No injuries have been reported.
- Check if you have Abiraterone Acetate 500 mg from Glenmark with lot number 13250135.
- Contact your pharmacy or doctor if you have this medication for guidance on next steps.
The agency's original wording
Hazard
Labeling: Not Elsewhere Classified
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the United States
Affected count
1296 bottles
Manufactured in
619 River Dr, Elmwood Park, New Jersey, United States
Products
Abiraterone Acetate Tablets USP 500 mg, 60-count bottles, Rx only, Distributed by: Glenmark Pharmaceuticals USA, Elmwood Park, NJ 07407, NDC 68462-882-60
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0074-2027More Glenmark recalls
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