Theophylline Extended-Release Tablets Recalled for Failed Dissolution Specifications
Glenmark Pharmaceuticals is recalling 22,656 bottles of Theophylline extended-release 400mg tablets nationwide due to failed dissolution specifications during stability testing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a dissolution specification failure in a prescription respiratory medication. Although no illnesses or injuries are reported in the source, this qualifies as a risk-of-harm product where the defect could affect drug bioavailability without yet-reported injury.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling 22,656 bottles of Theophylline extended-release tablets 400mg nationwide. The affected batches are 19243193, 19243215, 19243231, 19243248, and 19243283 (expiring July 31, 2026), 19244530 and 19244561 (expiring October 31, 2026), and 19250178 (expiring December 31, 2026).
The recall was initiated because the tablets failed dissolution testing specifications. During annual stability testing at the long-term shelf life interval, the tablets' dissolution test results did not comply with L3 stage dissolution criteria. Dissolution testing measures how completely and at what rate a tablet dissolves in the body, which is critical for ensuring proper drug delivery and effectiveness.
Patients who have this medication should contact their healthcare provider or pharmacist for guidance. Do not discontinue use of theophylline without consulting a healthcare professional, as this medication treats respiratory conditions and stopping it without guidance could affect your health.
The recalled product
- Product
- THEOPHYLLINE (THEOPHYLLINE)
- Brand
- THEOPHYLLINE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- dissolution-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Batch # 19243193
- 19243215
- 19243231
- 19243248
- 19243283
- Exp 7/31/2026
- 19244530
- 19244561
- Exp 10/31/2026
- 19250178
- Exp 12/31/2026
UPCs (2)
- 0368462380017
- 0368462356012
Distribution
Distributed nationwide across the United States.
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