CLASS III Drug recall · Reported 19 Nov 2014 · FDA Enforcement Report
Haloperidol Decanoate Injection, 50 mg/mL vial recalled
Fresenius Kabi USA is recalling Haloperidol Decanoate Injection, 50 mg/mL vial, distributed nationwide in the US. The recall was initiated on 14 Apr 2014 and the FDA has classified it as Class III.
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-0247-2015
- FDA event ID
- 68019
- Recalling firm
- Fresenius Kabi USA, Melrose Park, IL
- Manufacturer
- Fresenius Kabi USA, LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 14 Apr 2014
- FDA classified
- 13 Nov 2014
- Reported
- 19 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 14 Apr 2014 | Recall initiated by company | |
| 13 Nov 2014 | Classified by FDA | +213 days |
| 19 Nov 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
Which lots are affected?
Lot 6105149, Exp.05/14; 6105696, Exp. 07/14; 6105836, Exp. 08/14; Lot 6106516, Exp. 12/14; Lot 6106837, Exp. 02/15
Where was it sold?
Nationwide and Puerto Rico
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Fresenius Kabi USA
All 95| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Tyenne (tocilizumab-aazg) Injection, 400 mg/ (20 mg/mL) vial recalledTyenne | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS I | Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate | Fresenius Kabi USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Glycopyrrolate Injection, USP, 1 mg per (0.2 mg per mL) recalledGlycopyrrolate | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine | Fresenius Kabi USA | Particulate Matter | 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 |