CLASS II Drug recall · Reported 5 Jun 2013 · FDA Enforcement Report

Ropinirole hydrochloride tablets, USP 4 mg bottle recalled

Mylan Pharmaceuticals is recalling Ropinirole hydrochloride tablets, USP 4 mg bottle (, distributed nationwide in the US. The recall was initiated on 22 Apr 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # ZRMB11004, Exp 09/13

Quantity recalled3,048 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-500-2013
FDA event ID: 65008
Recalling firm: Mylan Pharmaceuticals, Morgantown, WV
Classification: Class II
Status: Terminated
Recall initiated: 22 Apr 2013
FDA classified: 30 May 2013
Reported: 5 Jun 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors

Timeline

22 Apr 2013	Recall initiated by company
30 May 2013	Classified by FDA	+38 days
5 Jun 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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..

Product as listed by the FDA

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

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

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..

Which lots are affected?

Lot # ZRMB11004, Exp 09/13

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Mylan Pharmaceuticals

All 84

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel	Mylan Pharmaceuticals	Potency & Assay	Nationwide
9 Sep 2026Drug	CLASS II	Carton label: Mycophenolate Mofetil for injection recalledMycophenolate Mofetil	Mylan Pharmaceuticals	Potency & Assay	Nationwide
26 Aug 2026Drug	CLASS II	Acamprosate Calcium, Delayed-Release Tablets, 333 mg recalledAcamprosate Calcium	Mylan Pharmaceuticals	Potency & Assay	Nationwide
5 Aug 2026Drug	CLASS II	Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil	Mylan Pharmaceuticals	Other	Nationwide
11 Mar 2026Drug	CLASS II	Amnesteem (Isotretinoin) Capsules, USP 40 mg recalledAmnesteem	Mylan Pharmaceuticals	Potency & Assay	Nationwide

Other Ropinirole recalls

All 13

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