Theophylline extended-release tablets 400mg — Class II drug recall D-0583-2025
Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2025-08-20, distributed nationwide. Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for
| Recall number | D-0583-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2025-08-08 |
| Classified | 2025-08-12 |
| Reported by FDA | 2025-08-20 |
| Distributed | Nationwide (US) |
| Quantity | 22,656 bottles |
| Reason classes | specification failure |
| NDC | 68462-0356, 68462-0356-01, 68462-0356-05, 68462-0380, 68462-0380-01, 68462-0380-05 |
| Lot numbers | 19243193, 19243215, 19243231, 19243248, 19243283, 19244530, 19244561, 19250178 |
| Expiration dates | 2026-07-31, 2026-10-31, 2026-12-31 |
Product
Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ, NDC 68462-380-01
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0583-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.