FDA Drug recall D-0710-2018
Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle
- FDA Drug
- Class III
- terminated
- Published 2018-05-09
On 2018-05-09 the FDA classified a Class III recall of Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle by Rhodes Pharmaceuticals L P, citing failed Dissolution Specification: Low dissolution outside of specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0710-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-04-17 |
| Published | 2018-05-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Rhodes Pharmaceuticals L P |
| Distribution | US |
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
Failed Dissolution Specification: Low dissolution outside of specifications
Identifiers
| code_info | Lot# AG8679B Exp. 01/2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0710-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.