Haloperidol decanoate Injection 50mg/mL recall
FDA recall D-0506-2024 · initiated Apr 24, 2024
SOMERSET THERAPEUTICS LLC recalled Haloperidol decanoate Injection 50mg/mL in Apr 2024 — an FDA Class II recall (D-0506-2024) because Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 5,578 units
Details
- Product
- Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India.
- Recalling company
- Somerset Therapeutics, LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Apr 24, 2024
- FDA report date
- May 29, 2024
Frequently asked
- Was Haloperidol decanoate Injection 50mg/mL recalled?
- SOMERSET THERAPEUTICS LLC recalled Haloperidol decanoate Injection 50mg/mL in Apr 2024 — an FDA Class II recall (D-0506-2024) because Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI). May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Haloperidol decanoate Injection 50mg/mL recalled?
- Per the FDA enforcement record, the reason for recall D-0506-2024 was: Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
- Is a recalled Haloperidol decanoate Injection 50mg/mL dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Haloperidol decanoate Injection 50mg/mL are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: a) A230412A, Exp. Date 07/2025; b)A230412B, Exp. Date 07/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0506-2024.