CLASS II Drug recall · Reported 17 Feb 2016 · FDA Enforcement Report
Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL amber recalled
Safecor Health is recalling Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL amber, distributed in New Jersey. The recall was initiated on 2 Mar 2015 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-0661-2016
- FDA event ID
- 72947
- Recalling firm
- Safecor Health, Woburn, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Mar 2015
- FDA classified
- 11 Feb 2016
- Reported
- 17 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 2 Mar 2015 | Recall initiated by company | |
| 11 Feb 2016 | Classified by FDA | +346 days |
| 17 Feb 2016 | 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
Defective Container: Confirmed customer complaints of leaking bottles.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
NJ
Questions about this recall
Why was it recalled?
Defective Container: Confirmed customer complaints of leaking bottles.
Which lots are affected?
Lot #846881; Exp 01/16
Where was it sold?
NJ
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.
More recalls from Safecor Health
All 30| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 2.5 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 5 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 5 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 10 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 20 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
Other Haloperidol recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Haloperidol Tablets 20mg recalled by Cardinal HealthHaloperidol | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |