CLASS II Drug recall · Reported 8 Feb 2017 · FDA Enforcement Report

Oxycodone Hydrochloride Oral Solution, USP 5 mg/, a) recalled

VistaPharm is recalling Oxycodone Hydrochloride Oral Solution, USP 5 mg/, a), distributed nationwide in the US. The recall was initiated on 18 Jan 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa). Lot No. 427900, 426700 (Exp. 11/17), 424800, 423600 (Exp. 10/17), 420800 (09/17), 416300 (08/17), 407700, 407300 (Exp. 06/17), 405900, 403900 (Exp. 05/17) b). Lot No. 426900 (Exp. 11/17), 404700 (Exp. 05/17), 390200 (Exp. 02/17)

Quantity recalled42,776 unit dose cups and 17,403 bottles

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-0464-2017
FDA event ID: 75650
Recalling firm: VistaPharm, Largo, FL
Classification: Class II
Status: Terminated
Recall initiated: 18 Jan 2017
FDA classified: 2 Feb 2017
Reported: 8 Feb 2017
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Drug class: Pain Medication

Timeline

18 Jan 2017	Recall initiated by company
2 Feb 2017	Classified by FDA	+15 days
8 Feb 2017	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

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5 mL per case (NDC No. 66689-401-50), b). 500 mL, 12 bottles per case (NDC No. 66689-403-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771.

Where it was distributed

Nationwide

Questions about this recall

Is Oxycodone Hydrochloride Oral Solution, USP 5 mg/, a) recalled?

Yes. VistaPharm recalled Oxycodone Hydrochloride Oral Solution, USP 5 mg/, a) on 18 Jan 2017. The recall is Class II and its status is Terminated. Recall number D-0464-2017.

Why was it recalled?

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Which lots are affected?

a). Lot No. 427900, 426700 (Exp. 11/17), 424800, 423600 (Exp. 10/17), 420800 (09/17), 416300 (08/17), 407700, 407300 (Exp. 06/17), 405900, 403900 (Exp. 05/17) b). Lot No. 426900 (Exp. 11/17), 404700 (Exp. 05/17), 390200 (Exp. 02/17)

Where was it sold?

Nationwide

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 21 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 VistaPharm

All 36

Reported	Class	Recall	Company	Reason	Where
6 Dec 2023Drug	CLASS III	Aminocaproic Acid Oral Solution/mL recalled by VistaPharm	VistaPharm	Packaging Defects	Nationwide
15 Nov 2023Drug	CLASS III	Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL recalledMycophenolate Mofetil	VistaPharm	Other	Nationwide
25 Oct 2023Drug	CLASS I	Sucralfate Oral Suspension per PET bottle) recalled by VistaPharmSucralfate	VistaPharm	Sterility	Nationwide
20 Sep 2023Drug	CLASS II	Sucralfate Oral Suspension per, For Oral Administration Only bottle) recalledSucralfate	VistaPharm	Potency & Assay	Nationwide
2 Nov 2022Drug	CLASS II	Pyridostigmine Bromide Oral Solution, USP 60 mg/ Delivers recalledPyridostigmine Bromide	VistaPharm	Potency & Assay	Nationwide

Other Oxycodone recalls

All 13

Reported	Class	Recall	Company	Reason	Where
18 Feb 2026Drug	CLASS II	Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone Hydrochloride	Amerisource Health Services	Packaging Defects	Nationwide
15 Nov 2023Drug	CLASS III	Oxaydo (oxycodone HCl, USP) tablets, 5 mg recalledOxaydo	Zyla Life Sciences US	Potency & Assay	Nationwide
16 Mar 2022Drug	CLASS II	Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg recalledOxycodone Hydrochloride	American Health Packaging	Potency & Assay	Nationwide
19 Jan 2022Drug	CLASS III	Oxycodone Hydrochloride Oral Solution, USP 5 mg per (1 mg/mL) recalled	Akorn	Labeling Errors	Nationwide
12 Jan 2022Drug	CLASS III	Oxycodone Hydrochloride Tablets, USP C-II, 5 mg recalledOxycodone Hydrochloride	Lupin Pharmaceuticals	Potency & Assay	NY, OH