Daytrana — Class II drug recall D-0473-2023
Ongoing recall by Noven Pharmaceuticals Inc, reported 2023-03-29, distributed nationwide. Defective Delivery System: Out of specification for shear.
| Recall number | D-0473-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Noven Pharmaceuticals Inc, Miami, FL, United States |
| Recall initiated | 2023-03-10 |
| Classified | 2023-03-20 |
| Reported by FDA | 2023-03-29 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 68968-5552, 68968-5552-03, 68968-5553, 68968-5553-03, 68968-5554, 68968-5554-03, 68968-5555, 68968-5555-03 |
| Lot numbers | 91474, 91958, 91959, 92198, 92199, 92478, 92479, 93040, 93041 |
| Expiration dates | 2023-03, 2023-06, 2023-07, 2023-08, 2023-09, 2023-10 |
Product
Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5555-3
Reason for recall
Defective Delivery System: Out of specification for shear.
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-0473-2023. 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.