Agency classClass IIOur severity:Severe FDA (Drugs)·D-0378-2021·Announced 2021-05-26

Teva Recalls Haloperidol Decanoate Injection Due to Sterility Concerns

Teva Pharmaceuticals is recalling specific lots of Haloperidol Decanoate Injection because the company cannot guarantee the product is sterile.

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 sterile injectable medication where a lack of sterility assurance poses a significant risk of serious health consequences, meeting the criteria for a Severe rating.

Plain-English summary

Teva Pharmaceuticals USA is recalling 7,020 vials of Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials. The recall was initiated due to a lack of assurance of sterility for the affected product.

The recalled product includes Lot # 31325394C with an expiration date of 09/2021 and Lot # 31327161B with an expiration date of 04/2022. The product was distributed nationwide. The NDC number for the recalled product is 0703-7131-03.

Healthcare providers and patients should stop using the affected vials and contact their pharmacist or the manufacturer for instructions on how to return the product.

The recalled product

Product: Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 0703-7131-03
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Injectable
Hazard: sterility
infection
Affected units: 7,020

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 # 31325394C
exp. date 09/2021 Lot # 31327161B
exp. date 04/2022

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