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.
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.
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.
The tablets failed dissolution tests, meaning they may not release medication as intended over time. This could lead to improper treatment levels. However, the hazard is not described as causing serious injury in normal use.
Prescription patients using the recalled theophylline tablets. Those with respiratory conditions requiring this medication are most at risk.
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.
Identify the batch number and expiration date on the product label to confirm if it is recalled.
The recall indicates the product failed dissolution testing, but the official notice does not state it causes serious injury. It may affect medication effectiveness.
The recall record does not specify a remedy. Contact Glenmark Pharmaceuticals for further instructions.
Check for theophylline extended-release tablets 400mg, 100-count bottles with NDC 68462-380-01 and batch numbers listed in the recall.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0583-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0583-2025 from Glenmark. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
