Haloperidol Decanoate Injection recall
FDA recall D-0369-2025 · initiated Apr 2, 2025
Amerisource Health Services LLC recalled Haloperidol Decanoate Injection in Apr 2025 — an FDA Class II recall (D-0369-2025) because Lack of assurance of sterility. Bacterial contamination detected in some media fill units.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
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: 143 1x5 vials
Details
- Product
- Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-581-48.
- Recalling company
- Amerisource Health Services LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Apr 2, 2025
- FDA report date
- Apr 30, 2025
Frequently asked
- Was Haloperidol Decanoate Injection recalled?
- Amerisource Health Services LLC recalled Haloperidol Decanoate Injection in Apr 2025 — an FDA Class II recall (D-0369-2025) because Lack of assurance of sterility. Bacterial contamination detected in some media fill units. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Haloperidol Decanoate Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0369-2025 was: Lack of assurance of sterility. Bacterial contamination detected in some media fill units
- Is a recalled Haloperidol Decanoate Injection 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 are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — A240482B, EXP 08/31/2026. 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-0369-2025.