FDA Drug recall D-66458-1
Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufactured in India by Sandoz Private Ltd, for Sandoz Inc, Princeto…
- FDA Drug
- Class II
- terminated
- Published 2013-11-13
On 2013-11-13 the FDA classified a Class II recall of Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufactured in India by Sandoz Private Ltd, for Sandoz Inc, Princeto… by Sandoz, citing cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended Release Tablets 2 mg due to the potential presence of carryover coming from the pr….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-66458-1 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-09 |
| Published | 2013-11-13 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sandoz |
| Distribution | US |
Product
Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufactured in India by Sandoz Private Ltd, for Sandoz Inc, Princeton, NJ 08540, NDC 0781-5780-92
Reason
Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended Release Tablets 2 mg due to the potential presence of carryover coming from the previously manufactured product, mycophenolate mofetil.
Identifiers
| code_info | Lot DJ2744, Exp 12/2014 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-66458-1%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.