Safecor Health Haloperidol Oral Solution Recall: FDA Class II

Why it was recalled

Defective Container: Confirmed customer complaints of leaking bottles.

Product description

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.

Lot numbers, UPCs & expiration codes

Lot #846881; Exp 01/16

Where it was sold

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0661-2016
Classification: Class II
Status: Terminated
Recall initiated: Mar 2, 2015
FDA report date: Feb 17, 2016
Quantity: 3,532 amber bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Safecor Health, LLC

Original FDA data

Every field from FDA enforcement report D-0661-2016, exactly as published.

Show all FDA fields

City: Woburn
State: MA
Status: Terminated
Country: United States
Event ID: 72947
Address: 317 New Boston St
Code information: Lot #846881; Exp 01/16
Postal code: 01801-6231
Report date: Feb 17, 2016
Product type: Drugs
Recall number: D-0661-2016
Classification: Class II
Recalling firm: Safecor Health, LLC
Product quantity: 3,532 amber bottles
Termination date: Feb 25, 2016
Reason for recall: Defective Container: Confirmed customer complaints of leaking bottles.
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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.
Distribution pattern: NJ
Recall initiation date: Mar 2, 2015
Initial firm notification: Letter
Center classification date: Feb 11, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0661-2016, published Feb 17, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Safecor Health Haloperidol Oral Solution Recall

Summary