Mylan Pharmaceuticals Ropinirole hydrochloride tablets Recall

Why it was 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..

Product description

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

Lot numbers, UPCs & expiration codes

Lot # ZRMB11004, Exp 09/13

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-500-2013
Classification: Class II
Status: Terminated
Recall initiated: Apr 22, 2013
FDA report date: Jun 5, 2013
Quantity: 3,048 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Mylan Pharmaceuticals Inc.

Original FDA data

Every field from FDA enforcement report D-500-2013, exactly as published.

Show all FDA fields

City: Morgantown
State: WV
Status: Terminated
Country: United States
Event ID: 65008
Address: 781 Chestnut Ridge Rd
Code information: Lot # ZRMB11004, Exp 09/13
Postal code: 26505-2730
Report date: Jun 5, 2013
Product type: Drugs
Recall number: D-500-2013
Classification: Class II
Recalling firm: Mylan Pharmaceuticals Inc.
Product quantity: 3,048 bottles
Termination date: Apr 14, 2014
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..
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: Nationwide
Recall initiation date: Apr 22, 2013
Initial firm notification: Letter
Center classification date: May 30, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-500-2013, published Jun 5, 2013. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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