Food, drugs, devices › Mylan Pharmaceuticals Inc.

Drug recall: Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only, Manufactured for: Mylan Pharma

FDA enforcement event 65008 · Class II · initiated 22 Apr 2013 · status Terminated · terminated 14 Apr 2014

DrugVoluntary: Firm initiated1 product recordMorgantown, WV

Mylan Pharmaceuticals Inc. (Morgantown, WV) initiated this drug recall on 22 Apr 2013; FDA lists 1 product record under event 65008, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 56% of the 370 drug enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 14 Apr 2014. Initiation: voluntary: firm initiated. Mylan Pharmaceuticals Inc. has 55 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Mylan Pharmaceuticals Inc., Morgantown, WV.

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.."

Distribution

"Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-500-2013	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	3,048 bottles	Class II	Terminated	5 Jun 2013

Context

56%of 2013 drug events are Class II370 events that year

1product record in this eventfirm median: 1

55events on this register for the firm

Other enforcement events for Mylan Pharmaceuticals Inc.

Initiated	Product (first record)	Type	Class	Records
26 Aug 2026	Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured	Drug	Class II	1
17 Aug 2026	Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morganto	Drug	Class II	1
24 Jul 2026	Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufact	Drug	Class II	1
2 Jul 2026	Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: M	Drug	Class II	1
24 Feb 2026	Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: My	Drug	Class II	1
25 Feb 2025	Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 265	Drug	Class II	1
5 Jul 2022	Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packag	Drug	Class I	1
12 Apr 2022	Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vial inside	Drug	Class I	1
7 Apr 2022	Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morga	Drug	Class II	1
1 Apr 2022	Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morga	Drug	Class II	1

All 55 events for Mylan Pharmaceuticals Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "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.."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 14 Apr 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.