VistaPharm Oxycodone Hydrochloride Oral Solution Recall

Why it was recalled

Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.

Product description

Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-01), shrink- wrapped in 10 unit dose cups x 5 trays per case (NDC 66689-401-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771

Lot numbers, UPCs & expiration codes

Lot # 435200, EXP 01/18

Where it was sold

Nationwide

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-0838-2016
Classification: Class II
Status: Terminated
Recall initiated: Apr 18, 2016
FDA report date: May 11, 2016
Quantity: 8,901 cases
Recall type: Voluntary: Firm initiated
Recalling firm: VistaPharm, Inc.

Original FDA data

Every field from FDA enforcement report D-0838-2016, exactly as published.

Show all FDA fields

City: Largo
State: FL
Status: Terminated
Country: United States
Event ID: 73909
Address: 7265 Ulmerton Rd
Code information: Lot # 435200, EXP 01/18
Postal code: 33771-4809
Report date: May 11, 2016
Product type: Drugs
Recall number: D-0838-2016
Classification: Class II
Recalling firm: VistaPharm, Inc.
Product quantity: 8,901 cases
Termination date: Aug 3, 2018
Reason for recall: Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-01), shrink- wrapped in 10 unit dose cups x 5 trays per case (NDC 66689-401-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771
Distribution pattern: Nationwide
Recall initiation date: Apr 18, 2016
Initial firm notification: E-Mail
Center classification date: May 4, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0838-2016, published May 11, 2016. View the source record (openFDA) · FDA enforcement reports

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

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