Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x1 mL carton)
Why it was recalled
Lack of Assurance of Sterility: Media fill with bacterial contamination
The recall was initiated by Somerset Therapeutics Private Limited (the firm that distributes or relabels it); the product is made by Somerset Therapeutics, LLC. That is normal — the distributor, not always the maker, files the recall.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
NDC 70069-381-01; A240467A, exp. date 07/2026; NDC 70069-381-10; A240467C, exp. date 07/2026
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
U.S. Nationwide
Recall record
- Recalling firm
- Somerset Therapeutics Private Limited
- Manufacturer
- Somerset Therapeutics, LLC
- Brand name
- HALOPERIDOL DECANOATE
- Generic name
- HALOPERIDOL DECANOATE
- Product type
- Drugs
- Recall number
- D-0355-2025
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Bengaluru, N/A
- Recall initiated
- 2025-03-21
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall D-0355-2025 · Source: openFDA enforcement.