Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Ropinirole recalled?

Not under an active recall. Ropinirole was recalled 13 times in the past — all now closed. Most recent: Mar 20, 2023.

Most common reason: cGMP deviation (11 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Ropinirole. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Ropinirole recalls on record

none so far in 2026; 13 on record, newest first
Class II · Moderate risk

Ropinirole

cGMP deviations

Terminated cGMP deviation Direct Rx NDC 72189-0364-30 D-0479-2023
Class II · Moderate risk

Ropinirole

cGMP deviations

Terminated cGMP deviation Direct Rx NDC 72189-0364-30 D-0478-2023
Class II · Moderate risk

rOPINIRole Tablets USP 3 mg*

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-236-01 D-0429-2023
Class II · Moderate risk

rOPINIRole Tablets USP 2 mg*

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-235-01 D-0428-2023
Class II · Moderate risk

rOPINIRole Tablets USP 1 mg*

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-234-01 D-0427-2023
Class II · Moderate risk

Ropinirole

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.

Terminated Cross-contamination Sandoz, Inc NDC 0781-5780-92 D-66458-1
Class II · Moderate risk

Ropinirole hydrochloride tablets

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..

Terminated Labeling / mix-up Mylan Pharmaceuticals Inc. NDC 0378-5504-01 D-500-2013