Use cautionDrug recall · FDA · Published March 2, 2015
Safecor Health Recalls Haloperidol Oral Solution Due to Leaking Bottles
Safecor Health recalls 3,532 bottles of Haloperidol Oral Solution due to defective containers causing leaks. Check your lot number and expiration date.
Defective Container: Confirmed customer complaints of leaking bottles.
Take action
Contact the company
📍Recalling firmSafecor Health, LLC317 New Boston St · Woburn, MA 01801-6231
✎ GovInfoNow plain-language explainer
Safecor Health, LLC is recalling Haloperidol Oral Solution, USP (Concentrate) because customers have confirmed that the amber bottles are leaking. The recall affects 3,532 units distributed in New Jersey. The product was manufactured by Silarx Pharmaceuticals Inc. and packaged by Safecor Health. Read more at govinfonow.com/recall/44910-safecor-health-llc-recalls-haloperidol-oral-solution-usp-concentrate-2.
“Safecor Health Recalls Haloperidol Oral Solution Due to Leaking Bottles.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/44910-safecor-health-llc-recalls-haloperidol-oral-solution-usp-concentrate-2. Based on FDA recall #D-0661-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0661-2016%22&limit=1).
Safecor Health, LLC recalled Haloperidol Oral Solution due to defective containers that may leak, the FDA said on March 2, 2015. The agency announced the Class II recall under number D-0661-2016.
The recall addresses confirmed customer complaints of leaking bottles. The defect poses a risk of product loss or contamination.
Context
GovInfoNow's records show Safecor Health, LLC has 11 other recalls on record since July 16, 2015. Other recent recalls include the August 13, 2026 Fluphenazine Elixir recall for failed stability specifications and the May 1, 2026 Vitamin B-Complex Liquid recall due to foreign particles. Similar product recalls in May 2026 included Keystone Dental City Topical Anesthetic Gel and Keystone DHP Topical Anesthetic Gel, both citing defective container risks.
How to tell if you have this one
Look for an amber bottle containing Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL. Check the label for Lot #846881 and an expiration date of 01/16. The NDC is 54838-0501-40. The product was distributed in New Jersey.
Brand
Safecor Health
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Your Bottle
Verify if your Haloperidol Oral Solution bottle matches Lot #846881 and expires on 01/16.
Contact Provider or Pharmacist
If you have the recalled product, contact your healthcare provider or pharmacist for instructions on disposal or replacement.
Where it went and when
Where it was distributed
Distributed in New Jersey.
Listed by the agency
Not listed
FDA distribution: “NJ” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New Jersey.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0661-2016 (March 2, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0661-2016 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 12, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.