Class II · Moderate risk
Haloperidol Lactate Injection
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Haloperidol Oral Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Defective Container: Confirmed customer complaints of leaking bottles.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL amber bottle, Rx Only, Manufactured by Silarx Pharmaceuticals Inc. Carmel, NY 10512, Packaged by Safecor Health, Woburn, MA 01801, NDC 54838-0501-40.
Affected NDC
54838-0501-40
Compare with the code on your package — it is the most precise check available.
Drug: Haloperidol
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Haloperidol NDC 54838-0501 |
LACTATE 2 mg/mL | Solution Oral |
Lannett Company, Inc. | Rx |
- Recalling firm
- Safecor Health, LLC
- NDC code
- 54838-0501-40
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0661-2016 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Haloperidol recalls
See all
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of Assurance of Sterility: Media fill with bacterial contamination
Other recalls by Safecor Health, LLC
All 2015 recalls
Class II · Moderate risk
Fluphenazine HCl Elixir
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Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
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