Teva Pharmaceuticals Haloperidol Decanoate Injection Recall

Why it was recalled

Lack of Assurance of Sterility

Product description

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Product was distributed nationwide.

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0378-2021
Classification: Class II
Status: Terminated
Recall initiated: Apr 26, 2021
FDA report date: May 26, 2021
Quantity: 7020 vials
Recall type: Voluntary: Firm initiated
Recalling firm: Teva Pharmaceuticals USA

Original FDA data

Every field from FDA enforcement report D-0378-2021, exactly as published.

Show all FDA fields

City: Parsippany
State: NJ
Status: Terminated
Country: United States
Event ID: 87875
Address: 400 Interpace Pkwy
Code information: Lot # 31325394C, exp. date 09/2021 Lot # 31327161B, exp. date 04/2022
Postal code: 07054-1120
Report date: May 26, 2021
Product type: Drugs
Recall number: D-0378-2021
Classification: Class II
Recalling firm: Teva Pharmaceuticals USA
Product quantity: 7020 vials
Termination date: Jun 4, 2024
Reason for recall: Lack of Assurance of Sterility
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: Product was distributed nationwide.
Recall initiation date: Apr 26, 2021
Initial firm notification: Letter
Center classification date: May 14, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0378-2021, published May 26, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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