Drug company (FDA labeler)

VistaPharm, LLC

NDC labeler code: 66689

What is a labeler?

The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.

Official FDA data only

Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.

Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.

At a glance

9Prescription medicines

14Products (NDC)

13FDA applications

7Recalls

Prescription medicines

Methadone hydrochlorideMethadone Hydrocloride Dye-Free, Sugar-Free, Unflavored, Methadose, Methadose Sugar-Free · 6 products
SucralfateCarafate · 1 product
Chlorhexidine gluconatePeriogard Alcohol Free, Dash Chlorhexidine Gluconate 0.12% Oral Rinse, Chlorhexidine Gluconate 0.12% Oral Rinse · 1 product
SirolimusHyftor, Fyarro · 1 product
Pyridostigmine bromideMestinon, Pryidostigmine Bromide, Regonol · 1 product
Mycophenolate mofetilCellcept, Myhibbin · 1 product
Metformin hydrochlorideGlumetza · 1 product
DigoxinLanoxin · 1 product
AripiprazoleAbilify, Opipza, Abilify Asimtufii · 1 product

FDA applications for these products

ANDA: Abbreviated New Drug Application: how a generic version is approved.

Approved	Application	Medicine	Sponsor
August 19, 2022	ANDA212677	Metformin hydrochloride METFORMIN HYDROCHLORIDE	Vistapharm LLC
March 15, 2022	ANDA211884	Sucralfate SUCRALFATE	Vistapharm LLC
March 16, 2020	ANDA204166	Methadone hydrochloride METHADONE HYDROCHLORIDE	Vistapharm LLC
December 26, 2019	ANDA212870	Aripiprazole ARIPIPRAZOLE	Vistapharm LLC
October 4, 2019	ANDA213000	Digoxin DIGOXIN	Vistapharm LLC
March 8, 2019	ANDA211694	Pyridostigmine bromide PYRIDOSTIGMINE BROMIDE	Novitium Pharma
February 12, 2019	ANDA210370	Mycophenolate mofetil MYCOPHENOLATE MOFETIL	Vistapharm LLC
January 28, 2019	ANDA211040	Sirolimus SIROLIMUS	Novitium Pharma
January 28, 2016	ANDA203212	Chlorhexidine gluconate PERIOGARD	Colgate-Palmolive Co
June 30, 2010	ANDA090707	Methadone hydrochloride METHADONE HYDROCHLORIDE	Vistapharm LLC
May 29, 1998	ANDA040241	Methadone hydrochloride METHADONE HYDROCHLORIDE	Vistapharm LLC
March 25, 1998	ANDA075082	Methadone hydrochloride METHADONE HYDROCHLORIDE	Vistapharm LLC
November 30, 1994	ANDA040088	Methadone hydrochloride METHADONE HYDROCHLORIDE	Vistapharm LLC

The sponsor is the company that holds the FDA application; it can differ from the labeler.

Recall timeline

2023

October 26, 2023 · Class III · Terminated · D-0093-2024 · Mycophenolate mofetil

Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.

Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#66689-307-08.
October 18, 2023 · Class I · Terminated · D-0047-2024 · Sucralfate

Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.

Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771 USA, NDC 66689-305-16
August 30, 2023 · Class II · Terminated · D-1149-2023 · Sucralfate

Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results

Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-305-16

2022

September 30, 2022 · Class II · Terminated · D-0018-2023 · Pyridostigmine bromide

cGMP Deviations: Out of specification for assay of one of the preservative ingredients.

Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 66689-406-01

2017

January 18, 2017 · Class II · Terminated · D-0466-2017 · Methadone hydrochloride

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

Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000 mL), 4 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-695-79.
January 18, 2017 · Class II · Terminated · D-0467-2017 · Methadone hydrochloride

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

Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-711-16.
January 18, 2017 · Class II · Terminated · D-0465-2017 · Methadone hydrochloride

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

Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (30 mL), 12 bottles per case (NDC No. 66689-695-30), b). 1 liter (1000 mL), 4 bottles per case, (NDC No. 66689-695-79), Rx only, Manufactured by

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Next steps

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Sources

NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

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