CLASS II Drug recall · Reported 1 Apr 2015 · FDA Enforcement Report

Haloperidol Decanoate Injection, 50 mg/mL recalled

Mylan Institutional is recalling Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only single dose vials (, distributed nationwide in the US. The recall was initiated on 18 Feb 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 7602368, Exp 7/16; Lot 7602369, Exp 7/16

NDC67457-409, 67457-410

Quantity recalled2,523 cartons (25,936 vials)

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-0422-2015
FDA event ID: 70564
Recalling firm: Mylan Institutional, Rockford, IL
Brand: Haloperidol Decanoate
Manufacturer: Mylan Institutional LLC
Classification: Class II
Status: Terminated
Recall initiated: 18 Feb 2015
FDA classified: 23 Mar 2015
Reported: 1 Apr 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

18 Feb 2015	Recall initiated by company
23 Mar 2015	Classified by FDA	+33 days
1 Apr 2015	Published in enforcement report	+9 days

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

Reason for recall

Lack of Assurance of Sterility; due to leaking vials

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

Nationwide and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility; due to leaking vials

Which lots are affected?

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

Where was it sold?

Nationwide and Puerto Rico

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.

Other products in this recall event

1 other product · FDA event 70564

This product is part of a recall event; the main page for the event is Haloperidol Decanoate Injection, 100 mg/mL recalled.

Reported	Class	Recall	Company	Reason	Where
1 Apr 2015	CLASS II	Haloperidol Decanoate Injection, 100 mg/mL recalledHaloperidol Decanoate	Mylan Institutional	Sterility	Nationwide

More recalls from Mylan Institutional

All 24

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26 Mar 2025Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg) recalledLevothyroxine Sodium	Mylan Institutional	Potency & Assay	Nationwide
26 Mar 2025Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg) recalledLevothyroxine Sodium	Mylan Institutional	Potency & Assay	Nationwide
18 Dec 2024Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 137 mcg recalledLevothyroxine Sodium	Mylan Institutional	Potency & Assay	Nationwide
18 Dec 2024Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 112 mcg recalledLevothyroxine Sodium	Mylan Institutional	Potency & Assay	Nationwide
18 Dec 2024Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 150 mcg recalledLevothyroxine Sodium	Mylan Institutional	Potency & Assay	Nationwide

Other Haloperidol Decanoate recalls

All 15

Reported	Class	Recall	Company	Reason	Where
30 Apr 2025Drug	CLASS II	Haloperidol Decanoate Injection, 50mg/mL* Single-Dose Vial recalledHaloperidol Decanoate	Amerisource Health Services	Sterility	Nationwide
30 Apr 2025Drug	CLASS II	Haloperidol Decanoate Injection, 100mg/mL*, mL Single-Dose Vials recalledHaloperidol Decanoate	Amerisource Health Services	Sterility	Nationwide
30 Apr 2025Drug	CLASS II	Haloperidol Decanoate Injection, 100 mg/mL*, mL Single-Dose Vial recalledHaloperidol Decanoate	Amerisource Health Services	Sterility	Nationwide
16 Apr 2025Drug	CLASS II	Haloperidol Decanoate Injection 100mg/mL Single-Dose Vial recalledHaloperidol Decanoate	Somerset Therapeutics Private	Sterility	Nationwide
16 Apr 2025Drug	CLASS II	Haloperidol Decanoate Injection 50mg/mL Single-Dose Vial recalledHaloperidol Decanoate	Somerset Therapeutics Private	Sterility	Nationwide