Haloperidol Decanoate Injections Recalled for Trace Water Contamination
Somerset Therapeutics is recalling Haloperidol Decanoate injections nationwide due to the potential presence of trace amounts of water in some vials, which may affect product quality.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a potential quality defect with no reported illnesses or injuries. Per the rubric, FDA Class II recalls without reported harm, where the hazard is theoretical and injury has not yet been reported, qualify as High severity.
Plain-English summary
Somerset Therapeutics LLC is recalling Haloperidol Decanoate Injection 50mg/mL due to the potential presence of trace amounts of water for injection in this oil-based product. The recall affects approximately 5,578 units of 1 mL single-dose vials and multi-packs distributed nationwide in the United States.
Water contamination in an oil-based injectable formulation is a quality control concern that could compromise the product's safety and efficacy. No illnesses or injuries have been reported in association with this product.
Patients taking this medication should contact their healthcare provider or pharmacist to determine if their supply contains affected product. The recall involves lot numbers A230412A and A230412B, both with an expiration date of July 2025. Healthcare providers should verify that patient supplies are not from the recalled lots and discuss appropriate alternatives if necessary.
The recalled product
- Product
- HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
- Brand
- HALOPERIDOL DECANOATE
- Manufacturer
- SOMERSET THERAPEUTICS LLC
- Category
- Drug — Prescription Injectable
- Hazard
- contamination-water
- quality-defect
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 #: a) A230412A
- Exp. Date 07/2025
- b)A230412B
UPCs (5)
- 0370069382011
- 0370069383018
- 0370069031018
- 0370069030011
- 0370069384015
Distribution
Distributed nationwide across the United States.
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