Agency classClass IIOur severity:Severe FDA (Drugs)·D-0732-2021·Announced 2021-08-25

Haloperidol Decanoate Injection recalled due to sterility concerns

Teva Pharmaceuticals USA is recalling Haloperidol Decanoate Injection 100 mg/mL due to lack of assurance of sterility. The recall affects 16,226 vials distributed nationwide, including Puerto Rico.

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 FDA classified this as a Class II recall. Lack of assurance of sterility in a parenteral drug product constitutes a serious hazard because non-sterile injections can cause life-threatening infections. This meets the rubric criterion for Severe (FDA Class II with risk of serious harm).

Plain-English summary

Teva Pharmaceuticals USA is recalling Haloperidol Decanoate Injection 100 mg/mL because the manufacturer cannot assure the sterility of the product. The recall includes two presentations: 1 mL single-dose vials (NDC 0703-7131-01) and 5 mL multi-dose vials (NDC 0703-7133-01), each containing 100 mg/mL of haloperidol decanoate.

The affected lots are: 31327056B (expiration 03/2022) and 31328547B (expiration 01/2023) for single-dose vials; and 31327066B (expiration 03/2022) for multi-dose vials. A total of 16,226 vials have been distributed nationwide, including Puerto Rico.

Haloperidol decanoate is a prescription antipsychotic medication administered by injection. Patients who have received injections from the recalled lots should contact their healthcare provider. Healthcare providers should stop using affected vials immediately and contact Teva Pharmaceuticals USA for information on returning the product and obtaining replacements.

The recalled product

Product: Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose vials (NDC 0703-7133-01), Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454.
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Injectable pharmaceutical
Hazard: lack-of-sterility
infection-risk
Affected units: 16,226

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 (5)

Lot #: a) 31327056B
exp. date 03/2022
31328547B
exp. date 01/2023
b) 31327066B

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 19 recalled by Teva Pharmaceuticals USA 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 19 products in this recall →

Same manufacturer · Teva Pharmaceuticals USA

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Same hazard · lack of sterility