Agency classClass IIOur severity:Severe FDA (Drugs)·D-0375-2021·Announced 2021-05-26

Teva Recalls Haloperidol Decanoate Injection Due to Sterility Concerns

Teva Pharmaceuticals is recalling 3,150 vials of Haloperidol Decanoate Injection due to a lack of assurance of sterility. The product was distributed nationwide.

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 involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of infection or serious injury.

Plain-English summary

Teva Pharmaceuticals USA is recalling 3,150 vials of Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials. The recall is being conducted due to a lack of assurance of sterility. The affected product is identified by Lot # 31325793C and has an expiration date of 09/2021.

The recalled product was distributed nationwide. Haloperidol Decanoate Injection is a prescription-only sterile medication. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and patients should discontinue use of the affected lot and contact Teva Pharmaceuticals for further instructions. Consumers should check their medication for the specific lot number and expiration date listed above.

The recalled product

Product: Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 00703-7121-03
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Injectable Medication
Hazard: sterility
infection
Affected units: 3,150

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 (2)

Lot # 31325793C
exp. date 09/2021

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

Same manufacturer · Teva Pharmaceuticals USA

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Same hazard · sterility