CLASS II ONGOING Drug recall · Reported 16 Apr 2025 · FDA Enforcement Report
Haloperidol Decanoate Injection 100mg/mL Single-Dose Vial recalled
Somerset Therapeutics Private is recalling Haloperidol Decanoate Injection 100mg/mL Single-Dose Vial, distributed nationwide in the US. The recall was initiated on 21 Mar 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-0357-2025
- FDA event ID
- 96569
- Recalling firm
- Somerset Therapeutics Private, Bengaluru, N/A
- Manufacturer
- BluePoint Laboratories
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Mar 2025
- FDA classified
- 8 Apr 2025
- Reported
- 16 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 21 Mar 2025 | Recall initiated by company | |
| 8 Apr 2025 | Classified by FDA | +18 days |
| 16 Apr 2025 | Published in enforcement report | +8 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: Media fill with bacterial contamination
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, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (individual carton) and NDC 68001-581-48 (5x1 mL cartons)
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Media fill with bacterial contamination
Which lots are affected?
NDC 68001-581-41; A240482A, exp. date 08/2026; NDC 68001-581-48; A240482B, exp. date 08/2026
Where was it sold?
U.S. Nationwide
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 96569This product is part of a recall event; the main page for the event is Haloperidol Decanoate Injection 50mg/mL Single-Dose Vial recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Haloperidol Decanoate Injection 50mg/mL Single-Dose Vial recalledHaloperidol Decanoate | Somerset Therapeutics Private | Sterility | Nationwide | |
| CLASS II | Methocarbamol Injection USP 1,000 mg/ (100 mg/mL) Single Dose Vial recalledMethocarbamol | Somerset Therapeutics Private | Sterility | Nationwide | |
| CLASS II | Haloperidol Decanoate Injection, 100 mg/mL Single-Dose Vial recalledHaloperidol Decanoate | Somerset Therapeutics Private | Sterility | Nationwide | |
| CLASS II | Haloperidol Decanoate Injection 50mg/mL Single-Dose Vial recalledHaloperidol Decanoate | Somerset Therapeutics Private | Sterility | Nationwide |
More recalls from Somerset Therapeutics Private
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Drug | CLASS II | Methocarbamol Injection USP 1,000 mg/ (100 mg/mL) Single Dose Vial recalledMethocarbamol | Somerset Therapeutics Private | Sterility | Nationwide |
| Drug | CLASS II | Haloperidol Decanoate Injection 50mg/mL Single-Dose Vial recalledHaloperidol Decanoate | Somerset Therapeutics Private | Sterility | 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, 100mg/mL*, mL Single-Dose Vials 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 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 |