Tolterodine Tartrate Extended-Release Capsules — Class III drug recall D-0304-2025
Terminated recall by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, reported 2025-04-09, distributed nationwide. Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for
| Recall number | D-0304-2025 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, La Vergne, TN, United States |
| Recall initiated | 2025-03-04 |
| Classified | 2025-03-28 |
| Reported by FDA | 2025-04-09 |
| Terminated | 2026-02-23 |
| Distributed | Nationwide (US) |
| Quantity | 224 cartons |
| Reason classes | specification failure |
| NDC | 00904-6592-04 |
| Lot numbers | T05393 |
| Expiration dates | 2025-09-30 |
Product
Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6592-04.
Reason for recall
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
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-0304-2025. 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.