CLASS II Drug recall · Reported 18 Dec 2013 · FDA Enforcement Report

Phenytoin Oral Suspension USP 125mg/, For Oral Administration Only recalled

VistaPharm is recalling Phenytoin Oral Suspension USP 125mg/, For Oral Administration Only, distributed nationwide in the US. The recall was initiated on 15 Oct 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots #'s: 268200, Exp 06/14; 274600, Exp 08/14; 279500, Exp 09/14; 290700, Exp 12/14; 296700, Exp 02/15; 305100, Exp 06/15

Quantity recalled27,788 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-342-2014
FDA event ID: 66945
Recalling firm: VistaPharm, Largo, FL
Classification: Class II
Status: Terminated
Recall initiated: 15 Oct 2013
FDA classified: 6 Dec 2013
Reported: 18 Dec 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Seizure Medication

Timeline

15 Oct 2013	Recall initiated by company
6 Dec 2013	Classified by FDA	+52 days
18 Dec 2013	Published in enforcement report	+12 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: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm Inc, Largo, FL 33771, NDC 66689-036-50

Where it was distributed

Nationwide and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.

Which lots are affected?

Lots #'s: 268200, Exp 06/14; 274600, Exp 08/14; 279500, Exp 09/14; 290700, Exp 12/14; 296700, Exp 02/15; 305100, Exp 06/15

Where was it sold?

Nationwide and Puerto Rico

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 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