CLASS II Drug recall · Reported 11 May 2016 · FDA Enforcement Report

Oxycodone Hydrochloride Oral Solution, USP 5 mg/ (1mg/ml) recalled

VistaPharm is recalling Oxycodone Hydrochloride Oral Solution, USP 5 mg/ (1mg/ml) (, distributed nationwide in the US. The recall was initiated on 18 Apr 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 435200, EXP 01/18

Quantity recalled8,901 cases

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-0838-2016
FDA event ID: 73909
Recalling firm: VistaPharm, Largo, FL
Classification: Class II
Status: Terminated
Recall initiated: 18 Apr 2016
FDA classified: 4 May 2016
Reported: 11 May 2016
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Drug class: Pain Medication

Timeline

18 Apr 2016	Recall initiated by company
4 May 2016	Classified by FDA	+16 days
11 May 2016	Published in enforcement report	+7 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: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.

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

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

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot # 435200, EXP 01/18

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 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 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 recalled	VistaPharm	Other	Nationwide
25 Oct 2023Drug	CLASS I	Sucralfate Oral Suspension per PET bottle) recalled by VistaPharmSucralfate	VistaPharm	Other Bacterial Contamination	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 19

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
14 Jan 2026Drug	CLASS II	Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg recalledOxycodone And Acetaminophen	SpecGx	Other	Nationwide
14 Jan 2026Drug	CLASS II	Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg recalledOxycodone And Acetaminophen	SpecGx	Other	Nationwide
15 Nov 2023Drug	CLASS III	Oxaydo (oxycodone HCl, USP) tablets, 7.5 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