Abiraterone Acetate Tablets USP 500 mg recall (Glenmark Pharmaceuticals Inc., USA)
DrugClass IIOngoing
Summary: Glenmark Pharmaceuticals Inc., USA is recalling 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.
What is being recalled
Abiraterone Acetate Tablets USP 500 mg, 60-count bottles, Rx only, Distributed by: Glenmark Pharmaceuticals USA, Elmwood Park, NJ 07407, NDC 68462-882-60
Why
Labeling: Not Elsewhere Classified
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide within the United States
How to tell if yours is affected
Lot #: 13250135, Exp. Date 11/2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0074-2027 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | October 9, 2026 |
| Reported | November 4, 2026 |
| Company | Glenmark Pharmaceuticals Inc., USA |
| Company location | Elmwood Park, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 1296 bottles |
More recalls from Glenmark Pharmaceuticals Inc., USA · all drug recalls · recalls from October 2026