Theophylline extended-release tablets failed dissolution at long-term stability testing
Theophylline extended-release tablets 400 mg from Glenmark are being recalled because dissolution results at the long-term shelf life stability interval did not comply with L3 stage criteria. 22,656 bottles affected.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: FDA Class II recall for an out-of-specification dissolution result found in stability testing, with no health consequence stated in the source.
Plain-English summary
Theophylline extended-release tablets, 400 mg, 100-count bottles, prescription only, manufactured by Glenmark Pharmaceuticals Limited of Goa, India for Glenmark Pharmaceuticals Inc. USA of Mahwah, New Jersey, are being recalled. The action covers 22,656 bottles.
The stated reason is failed dissolution specifications: failure results were reported for the dissolution test by UV for commercial annual stability at the long-term shelf life stability interval, where the dissolution results do not comply with L3 stage dissolution criteria. The FDA classified the action as Class II.
Affected batches include 19243193, 19243215, 19243231, 19243248 and 19243283 expiring 7/31/2026, together with the further batches listed in the recall notice. Distribution was nationwide in the USA.
Patients holding affected batches should speak to their pharmacist or prescriber before stopping treatment, and pharmacies should follow the instructions issued by Glenmark.
The recalled product
- Product
- THEOPHYLLINE (THEOPHYLLINE)
- Brand
- THEOPHYLLINE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Extended-release tablet
- Affected units
- 22,656
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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