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Use caution Drug recall · FDA · Published October 9, 2026

Glenmark Recalls Abiraterone Acetate Tablets Due to Labeling Issue

Glenmark Pharmaceuticals is recalling specific lots of Abiraterone Acetate Tablets USP 500 mg due to labeling errors. Check your bottle's lot number and expiration date.

🇺🇸 FDA recall #D-0074-2027DrugGlenmark Pharmaceuticals ›
✎ GovInfoNow plain-language explainer

What happened, in plain English

Glenmark Pharmaceuticals Inc., USA has issued a Class II recall for Abiraterone Acetate Tablets USP 500 mg in 60-count bottles. The recall is necessary because the product's labeling contains errors, though the specific nature of these errors is not detailed in the record. This affects 1,296 bottles distributed nationwide. Read more at govinfonow.com/recall/2084738-glenmark-pharmaceuticals-inc-usa-recalls-abiraterone-acetate-tablets-usp-500.

Source Summary by GovInfoNow · govinfonow.com/recall/2084738-glenmark-pharmaceuticals-inc-usa-recalls-abiraterone-acetate-tablets-usp-500 · Published November 10, 2026 · Updated November 11, 2026 · FDA enforcement record: FDA #D-0074-2027

Cite this page

“Glenmark Recalls Abiraterone Acetate Tablets Due to Labeling Issue.” GovInfoNow, updated November 11, 2026. https://govinfonow.com/recall/2084738-glenmark-pharmaceuticals-inc-usa-recalls-abiraterone-acetate-tablets-usp-500. Based on FDA recall #D-0074-2027 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0074-2027%22&limit=1).

Why it’s dangerous

The hazard stems from labeling errors on the packaging or container. Incorrect labeling can lead to medication confusion, such as taking the wrong dose or using expired medication, which poses a significant health risk for prescription drugs.

Who’s affected

Patients who have been prescribed Abiraterone Acetate Tablets USP 500 mg by a healthcare provider are affected. Specifically, individuals possessing bottles with Lot # 13250135 and an expiration date of 11/2027 are at risk.

How to tell if you have this one

Check your bottle of Abiraterone Acetate Tablets USP 500 mg (Rx only) distributed by Glenmark Pharmaceuticals USA. Look for NDC 68462-882-60, Lot # 13250135, and an expiration date of 11/2027.

  • Brand
    Glenmark Pharmaceuticals
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Your Bottle

    Verify if your bottle matches the recalled NDC 68462-882-60, Lot # 13250135, and Exp. Date 11/2027.

  2. Contact Your Pharmacist

    If you have the recalled product, contact your pharmacist or healthcare provider immediately for instructions on how to proceed.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 26 days after the firm started it.

1. Firm started the recall: Oct 9, 202612. FDA classified it Class II: Oct 23, 202623. Published in FDA’s Enforcement Report: Nov 4, 202634. Added to GovInfoNow: Nov 10, 202642026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Where were these tablets sold?

The tablets were distributed nationwide within the United States.

What is the NDC number for the recalled product?

The National Drug Code (NDC) is 68462-882-60.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0074-2027 (October 9, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0074-2027 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on November 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA