FDA recall, , Moderate risk
Glenmark Abiraterone Acetate Tablets
Abiraterone Acetate Tablets have a labeling issue.
Summary by Recall Canary from the FDA notice
What happened
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, due to a labeling issue classified as Not Elsewhere Classified by the FDA. The recall involves 1296 bottles and was initiated on October 9, 2026.
The product was distributed nationwide within the United States. The FDA added the recall to its Enforcement Report and classified it on October 23, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your bottle affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Abiraterone Acetate Tablets USP 500 mg, 60-count bottles
- NDC
- 68462-882-60
- Lot code
- 13250135
Recall details
- Company began the recall
- Sold in
Nationwide within the United States
- Company
- Glenmark Pharmaceuticals Inc., USA
- Hazard
- Labeling error
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 100128
- Recall number
- D-0074-2027
- Quantity recalled
- 1296 bottles
All recalls from Glenmark Pharmaceuticals Inc., USA
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
