Aptensio XR — Class III drug recall D-0710-2018
Terminated recall by Rhodes Pharmaceuticals, L.P., reported 2018-05-09, distributed nationwide. Failed Dissolution Specification: Low dissolution outside of specifications
| Recall number | D-0710-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Rhodes Pharmaceuticals, L.P., Coventry, RI, United States |
| Recall initiated | 2018-04-17 |
| Classified | 2018-05-03 |
| Reported by FDA | 2018-05-09 |
| Terminated | 2020-05-19 |
| Distributed | Nationwide (US) |
| Quantity | 2,454 bottles |
| Reason classes | specification failure |
| NDC | 42858-0402-45 |
| Lot numbers | AG8679B |
| Expiration dates | 2020-01 |
Product
Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle. Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI 02816. Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834. NDC 42858-402-45
Reason for recall
Failed Dissolution Specification: Low dissolution outside of specifications
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-0710-2018. 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.