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

Phenytoin Oral Suspension, USP 100 mg/ dose cups recalled by VistaPharm

VistaPharm is recalling Phenytoin Oral Suspension, USP 100 mg/ dose cups of, 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 codesLot No. 428700 (Exp. 11/17), 409500 (Exp. 06/17)

Quantity recalled12,059 unit dose cups

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-0460-2017
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: Seizure 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

Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case., Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-036-50.

Where it was distributed

Nationwide

Questions about this recall

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?

Lot No. 428700 (Exp. 11/17), 409500 (Exp. 06/17)

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 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.

Other products in this recall event

10 other products · FDA event 75650

This product is part of a recall event; the main page for the event is Metoclopramide Oral Solution, USP 10 mg/ dose cups recalled.

Reported	Class	Recall	Company	Reason	Where
8 Feb 2017	CLASS II	Metoclopramide Oral Solution, USP 10 mg/ dose cups recalled	VistaPharm	Sterility	Nationwide
8 Feb 2017	CLASS II	Lactulose Solution, USP dose cups recalled by VistaPharm	VistaPharm	Sterility	Nationwide
8 Feb 2017	CLASS II	Lactulose Solution, USP dose cups recalled by VistaPharm	VistaPharm	Sterility	Nationwide
8 Feb 2017	CLASS II	Nystatin Oral Suspension, USP, a) recalled by VistaPharm	VistaPharm	Sterility	Nationwide
8 Feb 2017	CLASS II	Hydrocodone Bitartrate and Acetaminophen Oral Solution recalled	VistaPharm	Sterility	Nationwide
8 Feb 2017	CLASS II	Methadone Hydrochloride Oral Concentrate, USP 5 mg/ C-II recalled	VistaPharm	Sterility	Nationwide
8 Feb 2017	CLASS II	Oxycodone Hydrochloride Oral Solution, USP 5 mg/, a) recalled	VistaPharm	Sterility	Nationwide
8 Feb 2017	CLASS II	Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II recalledMethadone Hydrochloride	VistaPharm	Sterility	Nationwide
8 Feb 2017	CLASS II	Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) recalledMethadone Hydrochloride	VistaPharm	Sterility	Nationwide
8 Feb 2017	CLASS II	Nystatin Oral Suspension, USP per mL, a) recalled by VistaPharm	VistaPharm	Sterility	Nationwide

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	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 Phenytoin recalls

All 10

Reported	Class	Recall	Company	Reason	Where
27 Dec 2023Drug	CLASS I	Phenytoin Oral Suspension, USP, 100 mg recalled	The Harvard Drug Group	Packaging Defects	Nationwide
15 Nov 2023Drug	CLASS II	Extended Phenytoin Sodium Capsules, USP, 100 mg recalledExtended Phenytoin Sodium	Amneal Pharmaceuticals of New York	Potency & Assay	Nationwide
21 Jun 2023Drug	CLASS II	Extended Phenytoin Sodium Capsules, USP, 100 mg recalledExtended Phenytoin Sodium	Amneal Pharmaceuticals of New York	Potency & Assay	LA, OH, PA
30 Nov 2022Drug	CLASS III	Phenytoin Sodium Injection, USP 100 mg recalledPhenytoin Sodium	Acella Pharmaceuticals	Packaging Defects	Nationwide
30 Nov 2022Drug	CLASS III	Phenytoin Sodium Injection, USP, 250 mg recalledPhenytoin Sodium	Acella Pharmaceuticals	Packaging Defects	Nationwide