[pending] THEOPHYLLINE (THEOPHYLLINE)
Pending LLM rewrite. Source: FDA_DRUG D-0583-2025.
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: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- THEOPHYLLINE (THEOPHYLLINE)
- Brand
- THEOPHYLLINE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Drugs
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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