Ropinirole recalls

The FDA has published 13 recalls involving Ropinirole since 2013. The latest was reported on 12 Apr 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 recalls13since 2013

Last 12 months0reported

Class I00% of total

Ongoing0latest 12 Apr 2023

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 13 100%Class III 0 0%

Why ropinirole is recalled

Companies

By year

20231185%
2013215%

All ropinirole recalls, newest first

13 total

Reported	Class	Recall	Company	Reason	Where
12 Apr 2023Drug	CLASS II	Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only recalled	RemedyRepack	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Ropinirole 2mg tablets recalled by RemedyRepack	RemedyRepack	Manufacturing (CGMP) Deviations	Nationwide
5 Apr 2023Drug	CLASS II	Ropinirole recalled by Direct Rx	Direct Rx	Manufacturing (CGMP) Deviations	Nationwide
5 Apr 2023Drug	CLASS II	Ropinirole recalled by Direct Rx	Direct Rx	Manufacturing (CGMP) Deviations	Nationwide
8 Mar 2023Drug	CLASS II	rOPINIRole Tablets USP 0.5 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 0.25 mg* recalled by Accord HealthcareRopinirole	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
13 Nov 2013Drug	CLASS II	Ropinirole, extended-release tablets, 2 mg recalled by Sandoz	Sandoz	Other	Nationwide
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.