Haloperidol Decanoate Injection recall
FDA recall D-0358-2025 · initiated Mar 21, 2025
Somerset Therapeutics Private Limited recalled Haloperidol Decanoate Injection in Mar 2025 — an FDA Class II recall (D-0358-2025) because Lack of Assurance of Sterility: Media fill with bacterial contamination.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility: Media fill with bacterial contamination
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: 240 vials
Details
- Product
- Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-383-10
- Recalling company
- Somerset Therapeutics Private Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide
- Initiated
- Mar 21, 2025
- FDA report date
- Apr 16, 2025
Frequently asked
- Was Haloperidol Decanoate Injection recalled?
- Somerset Therapeutics Private Limited recalled Haloperidol Decanoate Injection in Mar 2025 — an FDA Class II recall (D-0358-2025) because Lack of Assurance of Sterility: Media fill with bacterial contamination. 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-0358-2025 was: Lack of Assurance of Sterility: Media fill with bacterial contamination
- 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: U.S. Nationwide. The recall covers these lots — A240482D, exp. date 08/2026. 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-0358-2025.