thejoe VistaPharm, Inc.

VistaPharm, Inc.: 32 FDA recall reports

Every drug recall the FDA has published for VistaPharm, Inc.. The fault, and how the agency graded it.

32Reports

0Class I

0Ongoing

2022-11-02Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	24
Class III	8

By year reported

Year	Reports
2012	4
2013	2
2014	1
2015	1
2016	2
2017	16
2018	1
2020	3
2022	2

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Di

D-0018-2023 · Class II · reported 2022-11-02 · Terminated

Why it was recalled: cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
Product: 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
Where it went: USA Nationwide
How much: 1980 cups

Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 3377

D-0376-2022 · Class II · reported 2022-01-26 · Terminated

Why it was recalled: Failed Stability Specifications
Product: Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-058-04
Where it went: Nationwide within the United States including Puerto Rico
How much: 18,456 bottles

NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz.

D-0019-2021 · Class III · reported 2020-10-14 · Terminated

Why it was recalled: Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
Product: NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) Manufactured by: VistaPharm, Inc. Largo FL 33771, USA NDC 66689-008-16 UPC 6668900816,
Where it went: Distributed Nationwide in the USA including Puerto Rico
How much: 14,244 16 oz bottles

Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Lar

D-1377-2020 · Class III · reported 2020-07-15 · Terminated

Why it was recalled: Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Product: Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99.
Where it went: United States including Puerto Rico
How much: 380,700 cups

Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well

D-1378-2020 · Class III · reported 2020-07-15 · Terminated

Why it was recalled: Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Product: Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16.
Where it went: United States including Puerto Rico
How much: 14,760 bottles

NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml

D-0348-2019 · Class III · reported 2018-12-26 · Terminated

Why it was recalled: Failed Impurities/Degradation Specifications:Out of specification for impurities.
Product: NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 trays per case) NDC 66689-037-50; b) 100 unit dose cups (10x5ml unit dose cups per tray, 10 trays per case) NDC 66689-037-99. Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
Where it went: Nationwide in the USA and Puerto Rico
How much: 4,065,550 5 ml cups

Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottl

D-1139-2017 · Class III · reported 2017-09-20 · Terminated

Why it was recalled: Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
Product: Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16
Where it went: Nationwide
How much: 3084 bottles

Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufact

D-1052-2017 · Class II · reported 2017-08-09 · Terminated

Why it was recalled: Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Product: Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-50
Where it went: CA, IL, LA, NH, OH, PA, SC
How much: 6150 cases

Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case, Manufactur

D-1053-2017 · Class II · reported 2017-08-09 · Terminated

Why it was recalled: Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Product: Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-01
Where it went: CA, IL, LA, NH, OH, PA, SC
How much: 9945 cases

Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), an

D-0869-2017 · Class III · reported 2017-06-07 · Terminated

Why it was recalled: Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
Product: Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individual unit dose cup (NDC 66689-037-01) packaged in b) 50 count unit dose cups/case (NDC 66689-037-50) and c) 100 count unit dose cups/case (NDC 66689-037-99) Rx only, Manufactured by: VistaPharm, Largo, FL 33771.
Where it went: Nationwide in the US and Puerto Rico
How much: 2,208,500 cups/18696 bottles

Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15 mL unit dose cups (NDC 66689-047

D-0469-2017 · Class II · reported 2017-02-15 · Terminated

Why it was recalled: Defective Container: Leakage of unit dose cups that may occur at the seal.
Product: Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15 mL unit dose cups (NDC 66689-047-01), 50 unit dose cups per case (NDC 66689-047-50), Rx only, Xact Dose, Manufactured by VistaPharm, Largo, FL 33771.
Where it went: Domestic: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA WI, & WV.
How much: 13,609 cases

Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL per case, Rx only, Manufactured by

D-0459-2017 · Class II · reported 2017-02-08 · Terminated

Why it was recalled: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Product: Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-031-50.
Where it went: Nationwide
How much: 3,496 unit dose cups

Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx only, Manufactured by VistaPharm,

D-0463-2017 · Class II · reported 2017-02-08 · Terminated

Why it was recalled: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Product: Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-039-50.
Where it went: Nationwide
How much: 7,404 unit dose cups

Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx only, Manufactured by VistaPharm,

D-0462-2017 · Class II · reported 2017-02-08 · Terminated

Why it was recalled: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Product: Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-038-50.
Where it went: Nationwide
How much: 18,437 unit dose cups

Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 mL per case (NDC No. 66689-037-50

D-0461-2017 · Class II · reported 2017-02-08 · Terminated

Why it was recalled: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Product: Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 mL per case (NDC No. 66689-037-50), b). 100 unit dose cups of 5 mL per case (NDC 66689-037-99), Rx only, Manufactured by VistaPharm, Largo, FL 33771.
Where it went: Nationwide
How much: 55,191 unit dose cups

Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 1

D-0458-2017 · Class II · reported 2017-02-08 · Terminated

Why it was recalled: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Product: Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles per case (NDC 66689-023-04), b) 16 fl.oz. (473 mL), 12 bottles per case (NDC 66689-023-16), c) 50 unit dose cups of 15 mL per case, (NDC No. 66689-023-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771
Where it went: Nationwide
How much: 32,027 bottles and 16,310 unit dose cups

Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per case, Rx only, Manufacture

D-0467-2017 · Class II · reported 2017-02-08 · Terminated

Why it was recalled: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Product: 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.
Where it went: Nationwide
How much: 3,354 bottles

Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case., Rx only, Manufactured by Vis

D-0460-2017 · Class II · reported 2017-02-08 · Terminated

Why it was recalled: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Product: 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 went: Nationwide
How much: 12,059 unit dose cups

Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5 mL per case (NDC No. 66

D-0464-2017 · Class II · reported 2017-02-08 · Terminated

Why it was recalled: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Product: 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 went: Nationwide
How much: 42,776 unit dose cups and 17,403 bottles

Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000 mL), 4 bottles per cas

D-0466-2017 · Class II · reported 2017-02-08 · Terminated

Why it was recalled: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Product: 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.
Where it went: Nationwide
How much: 14,368 bottles

Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (30 mL), 12 bottles per case (NDC N

D-0465-2017 · Class II · reported 2017-02-08 · Terminated

Why it was recalled: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Product: 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 VistaPharm, Largo, FL 33771.
Where it went: Nationwide
How much: 127,193 bottles

Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC 66689-008-0

D-0457-2017 · Class II · reported 2017-02-08 · Terminated

Why it was recalled: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Product: Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC 66689-008-02), b) 16 fl. oz. (237 mL), 12 bottles per case (NDC 66689-008-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771
Where it went: Nationwide
How much: 67,955 bottles

Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose

D-0146-2017 · Class II · reported 2016-11-30 · Terminated

Why it was recalled: Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
Product: Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50), Rx only, Manufactured by VistaPharm, Inc., Largo, FL 33771.
Where it went: Nationwide
How much: 1497 cases

Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-01), shrink- wrapped in 10 unit d

D-0838-2016 · Class II · reported 2016-05-11 · Terminated

Why it was recalled: Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.
Product: 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 went: Nationwide
How much: 8,901 cases

METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only. Manufactured by VistaPharm, Inc, Largo, FL

D-1831-2015 · Class III · reported 2015-10-07 · Terminated

Why it was recalled: Defective Container: Lids on unit dose cups are not fully qualified.
Product: METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only. Manufactured by VistaPharm, Inc, Largo, FL. NDC: 66689-031-01.
Where it went: U.S. Including: CA, IL, LA, OH, PA, and SC.
How much: 84,100 Cups

METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, (present as the hydrochloride), 10 mL cups, Rx only. Manufactured

D-0010-2015 · Class II · reported 2014-10-15 · Terminated

Why it was recalled: Defective Container: Product leaks when inverted.
Product: METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, (present as the hydrochloride), 10 mL cups, Rx only. Manufactured by VistaPharm Inc., Largo, FL 33771. NDC 66689-031-01.
Where it went: U.S. Nationwide, including Puerto Rico
How much: 322,650 Cups

Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufacture

D-342-2014 · Class II · reported 2013-12-18 · Terminated

Why it was 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.
Product: 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 went: Nationwide and Puerto Rico
How much: 27,788 cases

Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, I

D-913-2013 · Class II · reported 2013-08-28 · Terminated

Why it was recalled: Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.
Product: Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
Where it went: Nationwide.
How much: 1,707,050 cups / 5ml ea.

METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only, Manufactured by VistaPharm, Inc

D-1669-2012 · Class III · reported 2012-09-05 · Terminated

Why it was recalled: Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," instead of "10 mL x 50,"
Product: METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only, Manufactured by VistaPharm, Inc., Largo FL33771
Where it went: Nationwide
How much: 73,800 cups

Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit dose cups, Manufactured by VistaPh

D-1658-2012 · Class II · reported 2012-08-29 · Terminated

Why it was recalled: Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume
Product: Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit dose cups, Manufactured by VistaPharm, Inc., Largo, FL --- NDC 66689-035-50
Where it went: Nationwide
How much: N/A

Showing the 30 most recent of 32. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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