CLASS II ONGOING Drug recall · Reported 29 May 2024 · FDA Enforcement Report
Haloperidol decanoate Injection 50mg/mL recalled
Somerset Therapeutics is recalling Haloperidol decanoate Injection 50mg/mL, distributed nationwide in the US. The recall was initiated on 24 Apr 2024 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-0506-2024
- FDA event ID
- 94452
- Recalling firm
- Somerset Therapeutics, Somerset, NJ
- Manufacturer
- Somerset Therapeutics, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Apr 2024
- FDA classified
- 21 May 2024
- Reported
- 29 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Injectable & IV Drugs
Timeline
| 24 Apr 2024 | Recall initiated by company | |
| 21 May 2024 | Classified by FDA | +27 days |
| 29 May 2024 | 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
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Haloperidol decanoate Injection 50mg/mL recalled?
Yes. Somerset Therapeutics recalled Haloperidol decanoate Injection 50mg/mL on 24 Apr 2024. The recall is Class II and its status is Ongoing. Recall number D-0506-2024.
Why was it recalled?
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Which lots are affected?
Lot #: a) A230412A, Exp. Date 07/2025; b)A230412B, Exp. Date 07/2025
Where was it sold?
Nationwide within the United States
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.
More recalls from Somerset Therapeutics
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dexamethasone Sodium Phosphate Injection, USP, 100 mg recalledDexamethasone Sodium Phosphate | Somerset Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS III | Cisatracurium Besylate Injection USP, 10 mg/* (2mg/mL) recalledCisatracurium Besylate | Somerset Therapeutics | Foreign Material | Nationwide |
| Drug | CLASS III | Cisatracurium Besylate Injection USP, 200mg/*(10mg/mL) recalledCisatracurium Besylate | Somerset Therapeutics | Foreign Material | Nationwide |
| Drug | CLASS III | Cisatracurium Besylate Injection USP, 20 mg/*,(2 mg/mL) recalledCisatracurium Besylate | Somerset Therapeutics | Foreign Material | Nationwide |
| Drug | CLASS III | Atropine Sulfate Ophthalmic Solution recalled by Somerset TherapeuticsAtropine Sulfate | Somerset Therapeutics | Potency & Assay | 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 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 |