Ropinirole recalls

The FDA has published 8 recalls involving Ropinirole since 2013. The latest was reported on 8 Mar 2023. Most were for manufacturing (cgmp) deviations. Accord Healthcare has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls8since 2013

Last 12 months0reported

Class I00% of total

Ongoing0latest 8 Mar 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 8 100%Class III 0 0%

Why ropinirole is recalled

Manufacturing (CGMP) Deviations788%
Labeling Errors113%

Companies

Accord Healthcare788%
Mylan Pharmaceuticals113%

By year

2023788%
2013113%

All ropinirole recalls, newest first

8 total

Reported	Class	Recall	Company	Reason	Where
8 Mar 2023Drug	CLASS II	rOPINIRole Tablets USP 5 mg* recalled by Accord HealthcareRopinirole	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	rOPINIRole Tablets USP 4 mg* recalled by Accord HealthcareRopinirole	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	rOPINIRole Tablets USP 1 mg* recalled by Accord HealthcareRopinirole	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	rOPINIRole Tablets USP 3 mg* recalled by Accord HealthcareRopinirole	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	rOPINIRole Tablets USP 5 mg* recalled by Accord HealthcareRopinirole	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	rOPINIRole Tablets USP 2 mg* recalled by Accord HealthcareRopinirole	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	rOPINIRole Tablets USP 25 mg* recalled by Accord HealthcareRopinirole	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
5 Jun 2013Drug	CLASS II	Ropinirole hydrochloride tablets, USP 4 mg bottle recalled	Mylan Pharmaceuticals	Labeling Errors	Nationwide

Should you stop taking Ropinirole?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.