Mylan Institutional Haloperidol Decanoate Injection Recall

Why it was recalled

Lack of Assurance of Sterility; due to leaking vials

Product description

Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten (NDC 67457-410-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103

Lot numbers, UPCs & expiration codes

Lot 7602368, Exp 7/16; Lot 7602369, Exp 7/16

Where it was sold

Nationwide and Puerto Rico

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-0422-2015
Classification: Class II
Status: Terminated
Recall initiated: Feb 18, 2015
FDA report date: Apr 1, 2015
Quantity: 2,523 cartons (25,936 vials)
Recall type: Voluntary: Firm initiated
Recalling firm: Mylan Institutional LLC

Original FDA data

Every field from FDA enforcement report D-0422-2015, exactly as published.

Show all FDA fields

City: Rockford
State: IL
Status: Terminated
Country: United States
Event ID: 70564
Address: 4901 Hiawatha Dr
Code information: Lot 7602368, Exp 7/16; Lot 7602369, Exp 7/16
Postal code: 61103-1287
Report date: Apr 1, 2015
Product type: Drugs
Recall number: D-0422-2015
Classification: Class II
Recalling firm: Mylan Institutional LLC
Product quantity: 2,523 cartons (25,936 vials)
Termination date: Feb 23, 2017
Reason for recall: Lack of Assurance of Sterility; due to leaking vials
Voluntary / mandated: Voluntary: Firm initiated
Product description: Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten (NDC 67457-410-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103
Distribution pattern: Nationwide and Puerto Rico
Recall initiation date: Feb 18, 2015
Initial firm notification: Letter
Center classification date: Mar 23, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0422-2015, published Apr 1, 2015. 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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