Theophylline Extended-Release Tablets Recalled for Dissolution Testing Failure
Glenmark Pharmaceuticals is recalling Theophylline extended-release tablets nationwide due to failed dissolution testing. The tablets may not release the medication at the proper rate.
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 with dissolution specification failure for a medication used in serious respiratory conditions. No reported illnesses, hospitalizations, or adverse events are documented in the source, limiting the score to a maximum of 3 per the rubric for theoretical hazards without reported injury.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Theophylline (Anhydrous) Extended-Release Tablets, 600 mg (NDC 68462-356-01) due to out-of-specification (OOS) results reported during dissolution testing.
Affected lots include 19234121 and 19234148 (expiring September 30, 2025) and 19242881 and 19242899 (expiring June 30, 2026). Approximately 8,520 bottles containing 100 tablets each were distributed nationwide.
Dissolution testing failure means the tablets may not release the active ingredient at the rate specified for this extended-release formulation. This could affect how the medication works in patients. Consumers or healthcare providers with questions should contact their healthcare provider or pharmacist to determine if their medication is affected and what steps to take.
The recalled product
- Product
- THEOPHYLLINE (THEOPHYLLINE)
- Brand
- THEOPHYLLINE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- dissolution-defect
- bioavailability-risk
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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