Agency classClass IIOur severity:Severe FDA (Drugs)·D-0422-2015·Announced 2015-04-01

Mylan Recalls Haloperidol Decanoate Injection Due to Sterility Concerns

Mylan Institutional LLC is recalling Haloperidol Decanoate Injection because leaking vials raised concerns about the product's sterility.

The agency’s classification

FDA (Drugs): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of infection or serious injury.

Plain-English summary

Mylan Institutional LLC is recalling Haloperidol Decanoate Injection, 50 mg/mL, for intra-muscular use. The recall involves 2,523 cartons (25,936 vials) of the medication, which is packaged in 1 mL single-dose vials. The affected lots are 7602368 and 7602369, both with an expiration date of 7/16.

The recall was initiated due to a lack of assurance of sterility caused by leaking vials. The product was distributed nationwide and in Puerto Rico. Haloperidol Decanoate is a prescription-only medication manufactured in India for Mylan Institutional LLC.

Healthcare providers and patients should stop using the affected lots and contact Mylan Institutional LLC for further instructions or replacement products. Consumers should not use the recalled medication and should consult their healthcare provider regarding alternative treatments.

The recalled product

Product: HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
Brand: HALOPERIDOL DECANOATE
Manufacturer: Mylan Institutional LLC
Category: Drug — Injectable Prescription Medication
Hazard: sterility
leaking-vial

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Lot 7602368
Exp 7/16
Lot 7602369

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Mylan Institutional LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same brand · HALOPERIDOL DECANOATE

Severe
Haloperidol Decanoate Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2025-04-30
Severe
Haloperidol Decanoate Injection Recalled Due to Sterility Concerns
FDA (Drugs) · 2025-04-30
Severe
Haloperidol Decanoate Injection Recalled Due to Sterility Concerns
FDA (Drugs) · 2025-04-30
Severe
Haloperidol Decanoate Injection Recalled for Sterility Assurance Failure
FDA (Drugs) · 2025-04-16
Severe
Haloperidol Decanoate Injection Recalled for Sterility Assurance Failure
FDA (Drugs) · 2025-04-16

Same manufacturer · Mylan Institutional LLC

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Same hazard · sterility