CLASS II ONGOING Drug recall · Reported 30 Apr 2025 · FDA Enforcement Report
Haloperidol Decanoate Injection, 100mg/mL*, mL Single-Dose Vials recalled
Amerisource Health Services is recalling Haloperidol Decanoate Injection, 100mg/mL*, mL Single-Dose Vials, distributed nationwide in the US. The recall was initiated on 2 Apr 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0369-2025
- FDA event ID
- 96636
- Recalling firm
- Amerisource Health Services, Columbus, OH
- Manufacturer
- BluePoint Laboratories
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Apr 2025
- FDA classified
- 18 Apr 2025
- Reported
- 30 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 2 Apr 2025 | Recall initiated by company | |
| 18 Apr 2025 | Classified by FDA | +16 days |
| 30 Apr 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Haloperidol Decanoate Injection, 100mg/mL*, mL Single-Dose Vials recalled?
Yes. Amerisource Health Services recalled Haloperidol Decanoate Injection, 100mg/mL*, mL Single-Dose Vials on 2 Apr 2025. The recall is Class II and its status is Ongoing. Recall number D-0369-2025.
Why was it recalled?
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Which lots are affected?
A240482B, EXP 08/31/2026
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS III | Primidone Tablets, USP, 250 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS III | Primidone Tablets, USP, 50 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Meclizine Hydrochloride Tablets, USP 5 mg, (a) [] recalledMeclizine Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Prazosin Hydrochloride, Capsules, USP, 1 mg recalledPrazosin Hydrochloride | Amerisource Health Services | Nitrosamine Impurity | Nationwide |
Other Haloperidol Decanoate recalls
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Haloperidol Decanoate Injection, 50mg/mL* Single-Dose Vial recalledHaloperidol Decanoate | Amerisource Health Services | Sterility | Nationwide |
| Drug | CLASS II | Haloperidol Decanoate Injection, 100 mg/mL*, mL Single-Dose Vial recalledHaloperidol Decanoate | Amerisource Health Services | Sterility | Nationwide |
| Drug | CLASS II | Haloperidol Decanoate Injection 100mg/mL Single-Dose Vial recalledHaloperidol Decanoate | Somerset Therapeutics Private | Sterility | Nationwide |
| Drug | CLASS II | Haloperidol Decanoate Injection 50mg/mL Single-Dose Vial recalledHaloperidol Decanoate | Somerset Therapeutics Private | Sterility | Nationwide |
| Drug | CLASS II | Haloperidol Decanoate Injection, 100 mg/mL Single-Dose Vial recalledHaloperidol Decanoate | Somerset Therapeutics Private | Sterility | Nationwide |