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.
What this means for you
Illness, injury, or structural failure has been reported. 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
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.
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