Theophylline Extended-Release Tablets recalled for dissolution test failure
Glenmark Pharmaceuticals is recalling Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, due to out-of-specification results on dissolution testing. The recall affects 8,520 bottles distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard—dissolution test failure—is a quality/manufacturing defect without documented adverse health consequences, placing it in the Moderate category per the rubric.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Theophylline (Anhydrous) Extended-Release Tablets, 600 mg (NDC: 68462-356-01), manufactured by Glenmark Pharmaceuticals Limited in Colvale-Bardez, Goa, India. The recall was initiated due to out-of-specification results reported for the Dissolution (by UV) test.
The affected product consists of 8,520 bottles (100 tablets per bottle) distributed nationwide in the USA. The specific lot numbers subject to recall are: Lots 19234121 and 19234148 (expiring September 30, 2025) and Lots 19242881 and 19242899 (expiring June 30, 2026).
Consumers who have bottles of Theophylline (Anhydrous) Extended-Release Tablets matching the affected lot numbers should stop using the product and contact their pharmacist or healthcare provider. Do not discard the medication; return it to your pharmacy for proper disposal. Patients should consult their physician regarding alternative therapy or next steps.
The recalled product
- Product
- THEOPHYLLINE (THEOPHYLLINE)
- Brand
- THEOPHYLLINE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Hazard
- dissolution-defect
- quality-control-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 (6)
- Lots: 19234121
- 19234148
- Exp Sep-30-25
- Lots 19242881
- 19242899
- Exp Jun-30-26
UPCs (2)
- 0368462380017
- 0368462356012
Distribution
Distributed nationwide across the United States.
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