Glenmark Recalls Theophylline 600 mg Tablets Due to Dissolution Failure
Glenmark Pharmaceuticals recalls specific lots of Theophylline 600 mg extended-release tablets because they fail dissolution tests, potentially affecting drug potency.
Use caution until it’s fixed
OOS results reported for the Dissolution (by UV) test.
Contact the company
What happened, in plain English
Glenmark Pharmaceuticals Inc., USA is recalling specific lots of Theophylline (Anhydrous) Extended-Release Tablets, 600 mg. The recall was initiated because Out-of-Specification (OOS) results were reported for the Dissolution test. This means the tablets may not release the medication into the body as intended. Read more at govinfonow.com/recall/32076-glenmark-recalls-theophylline-600-mg-tablets-due-to-dissolution-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/32076-glenmark-recalls-theophylline-600-mg-tablets-due-to-dissolution-failure · Updated October 9, 2026 · FDA enforcement record: FDA #D-0452-2025
Cite this page
“Glenmark Recalls Theophylline 600 mg Tablets Due to Dissolution Failure.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32076-glenmark-recalls-theophylline-600-mg-tablets-due-to-dissolution-failure. Based on FDA recall #D-0452-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0452-2025%22&limit=1).
Why it’s dangerous
The product failed the Dissolution test, which measures how well a drug releases its active ingredient. If the tablets do not dissolve properly, patients may receive less medication than prescribed, potentially leading to inadequate treatment of their condition.
Who’s affected
Patients currently taking Theophylline 600 mg extended-release tablets prescribed by a healthcare provider. Individuals who purchased the specific lots listed in this recall are at risk of receiving medication that may not work effectively.
How to tell if you have this one
Check your bottle for NDC 68462-356-01 and look for one of the following lot numbers: 19234121 (Expires Sep-30-25), 19234148 (Expires Sep-30-25), 19242881 (Expires Jun-30-26), or 19242899 (Expires Jun-30-26). The product is manufactured by Glenmark Pharmaceuticals Limited in India and distributed nationwide in the USA.
- Brand
Glenmark- Category
Drug
What to do — step by step
Check your medication
Verify if your bottle has NDC 68462-356-01 and matches one of the recalled lot numbers listed above.
Contact your pharmacist
If you have a recalled product, contact your pharmacy or healthcare provider to discuss returning the medication and obtaining a replacement.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 20 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-0452-2025 (May 15, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0452-2025 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 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.