Theophylline extended-release tablets 400mg recall
FDA recall D-0583-2025 · initiated Aug 8, 2025
Glenmark Pharmaceuticals Inc., USA recalled Theophylline extended-release tablets 400mg in Aug 2025 — an FDA Class II recall (D-0583-2025) because 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.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
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.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 22,656 bottles
Details
- Product
- Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ, NDC 68462-380-01
- Recalling company
- Glenmark Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA nationwide.
- Initiated
- Aug 8, 2025
- FDA report date
- Aug 20, 2025
Frequently asked
- Was Theophylline extended-release tablets 400mg recalled?
- Glenmark Pharmaceuticals Inc., USA recalled Theophylline extended-release tablets 400mg in Aug 2025 — an FDA Class II recall (D-0583-2025) because 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. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Theophylline extended-release tablets 400mg recalled?
- Per the FDA enforcement record, the reason for recall D-0583-2025 was: 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.
- Is a recalled Theophylline extended-release tablets 400mg dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Theophylline extended-release tablets 400mg are affected?
- Distributed: USA nationwide.. The recall covers these lots — Batch # 19243193, 19243215, 19243231,19243248, 19243283, Exp 7/31/2026; 19244530, 19244561, Exp 10/31/2026; 19250178, Exp 12/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0583-2025.