Lower risk Drug recall · FDA · Published August 8, 2025

Glenmark Theophylline Tablets 400mg Recall: Failed Dissolution Test Risk

Glenmark Pharmaceuticals recalls 400mg theophylline extended-release tablets with failed dissolution test results. These Rx-only tablets may not release medication properly over time. Consumers should contact the manufacturer for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0583-2025Drug Glenmark ›

Lower-risk recall

Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.

Take action

Contact the company

Recalling firmGlenmark Pharmaceuticals Inc., USA750 Corporate Dr · Mahwah, NJ 07430-2009

✎ GovInfoNow plain-language explainer

Glenmark Pharmaceuticals is recalling 400mg theophylline extended-release tablets that failed dissolution testing. This means the medication might not release properly over time, potentially affecting treatment effectiveness. Read more at govinfonow.com/recall/31876-glenmark-theophylline-tablets-400mg-recall-failed-dissolution-test-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/31876-glenmark-theophylline-tablets-400mg-recall-failed-dissolution-test-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0583-2025

Cite this page

“Glenmark Theophylline Tablets 400mg Recall: Failed Dissolution Test Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/31876-glenmark-theophylline-tablets-400mg-recall-failed-dissolution-test-risk. Based on FDA recall #D-0583-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0583-2025%22&limit=1).

The FDA announced on Aug. 8, 2025, that Glenmark Pharmaceuticals Inc., USA voluntarily recalled Theophylline extended-release tablets 400mg due to failed dissolution specifications. The agency issued recall number D-0583-2025 for the Class II recall affecting products distributed nationwide.

How to tell if you have it

Brand: Glenmark
Product: Theophylline extended-release tablets 400mg, 100-count bottle
NDC: 68462-380-01
Batch numbers: 19243193, 19243215, 19243231, 19243248, 19243283 (Exp 7/31/2026); 19244530, 19244561 (Exp 10/31/2026); 19250178 (Exp 12/31/2026)
Quantity: 22,656 bottles

The hazard

The FDA stated that the recall is due to failure results for the Dissolution (by UV) test during commercial annual stability at the long-term shelf life interval. These results do not comply with L3 stage dissolution criteria, according to the agency.

Context

GovInfoNow's records show Glenmark Pharmaceuticals Inc., USA has 54 other recalls on record since Nov. 20, 2017. Other recent recalls of similar products include Glenmark Azelaic Acid Gel 15% Recall (July 23, 2026), Glenmark Alyacen Birth Control Tablets Recall (May 27, 2026), and Glenmark Ondansetron Tablets Recall (Dec. 30, 2025). Other recent recalls of similar products include Ascend Minocycline Tablets Recall (June 1, 2026), Teva Metoprolol Succinate Tablets Recall (Jan. 29, 2026), and Golden State NIACIN Extended-Release Tablets Recall (May 29, 2026).

How to tell if you have this one

Check for theophylline extended-release tablets 400mg, 100-count bottles with NDC 68462-380-01. Look for batch numbers 19243193, 19243215, 19243231, 19243248, 19243283, 19244530, or 19244561. The expiration dates range from 7/31/2026 to 10/31/2026.

Brand
Glenmark
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the batch number and expiration date on the product label to confirm if it is recalled.

Where it went and when

Where it was distributed

Distributed nationwide.

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

Distributed nationwide.

Recall timeline

FDA published this recall 12 days after the firm started it.

Aug 8, 2025Firm started the recall
Aug 12, 2025FDA classified it Class II
Aug 20, 2025Published in FDA’s Enforcement Report

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

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Other Glenmark recalls

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/31876-glenmark-theophylline-tablets-400mg-recall-failed-dissolution-test-risk">Glenmark Theophylline Tablets 400mg Recall: Failed Dissolution Test Risk (GovInfoNow)</a>

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-0583-2025 (August 8, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0583-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.