Ropinirole hydrochloride tablets — Class II drug recall D-500-2013
Terminated recall by Mylan Pharmaceuticals Inc., reported 2013-06-05, distributed nationwide. Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be in
| Recall number | D-500-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc., Morgantown, WV, United States |
| Recall initiated | 2013-04-22 |
| Classified | 2013-05-30 |
| Reported by FDA | 2013-06-05 |
| Terminated | 2014-04-14 |
| Distributed | Nationwide (US) |
| Quantity | 3,048 bottles |
| Reason classes | labeling, potency |
| NDC | 00378-5504-01 |
| Lot numbers | 09/13, ZRMB11004 |
Product
Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. Made in India
Reason for recall
Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets..
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-500-2013. 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.