The Recall Desk

Manufacturer

VistaPharm, Inc.

32 recalls in our database name VistaPharm, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
32
Critical
0
Severe
14
Most recent
2022-11-02

Of the 32 recalls from VistaPharm, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 14 (44%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 32

  • ModerateFDA (Drugs)·D-0376-2022·2022-01-26

    Clobazam Oral Suspension Recalled for Failed Stability Specifications

    VistaPharm is recalling Clobazam Oral Suspension 2.5 mg/mL due to failed stability specifications. The recall affects 18,456 bottles distributed nationwide.

    Product
    Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-058-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0019-2021·2020-10-14

    VistaPharm Recalls Nystatin Oral Suspension Due to Impurity

    VistaPharm is recalling Nystatin Oral Suspension because one lot failed impurity specifications. The affected product was distributed nationwide.

    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,
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1378-2020·2020-07-15

    VistaPharm Recalls Nystatin Oral Suspension Due to Impurity Exceeding Specifications

    VistaPharm is recalling Nystatin Oral Suspension because an impurity peak exceeded approved specifications. The affected product is distributed in the United States and Puerto Rico.

    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.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-1377-2020·2020-07-15

    VistaPharm Recalls Nystatin Oral Suspension Due to Impurity Peak

    VistaPharm is recalling Nystatin Oral Suspension cups because an impurity peak exceeded approved specifications. The recall covers 380,700 cups distributed in the United States and Puerto Rico.

    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.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0348-2019·2018-12-26

    VistaPharm Recalls Nystatin Oral Suspension Due to Impurity Failures

    VistaPharm is recalling Nystatin Oral Suspension because it failed impurity specifications. The affected product is distributed nationwide and in Puerto Rico.

    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, Manufact
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1139-2017·2017-09-20

    VistaPharm Recalls Hydrocodone and Acetaminophen Oral Solution Due to Labeling Error

    VistaPharm, Inc. is recalling 3,084 bottles of Hydrocodone Bitartrate and Acetaminophen Oral Solution because the product was incorrectly labeled as a Class III controlled substance instead of a 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
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1052-2017·2017-08-09

    VistaPharm Recalls Lactulose Solution Due to Microbial Contamination

    VistaPharm is recalling Lactulose Solution, USP, because the product failed microbial testing for yeast and mold counts.

    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
    Category
    Drug
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-1053-2017·2017-08-09

    VistaPharm Recalls Lactulose Solution Due to Microbial Contamination

    VistaPharm is recalling Lactulose Solution, USP, because the product failed microbial testing for yeast and mold counts.

    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
    Category
    Drug
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0869-2017·2017-06-07

    VistaPharm Recalls Nystatin Oral Suspension Due to Impurity

    VistaPharm is recalling Nystatin Oral Suspension because it contains an impurity peak that exceeds approved specifications.

    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 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0469-2017·2017-02-15

    VistaPharm Recalls Potassium Chloride Oral Solution Due to Cup Leakage

    VistaPharm is recalling 13,609 cases of Potassium Chloride Oral Solution because the unit dose cups may leak 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.
    Category
    Drug
    Distribution
    36 states
  • SevereFDA (Drugs)·D-0464-2017·2017-02-08

    VistaPharm Recalls Oxycodone Hydrochloride Oral Solution Due to Water Contamination

    VistaPharm is recalling Oxycodone Hydrochloride Oral Solution because the purified water used in manufacturing 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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0460-2017·2017-02-08

    VistaPharm Recalls Phenytoin Oral Suspension Due to Water Contamination

    VistaPharm is recalling Phenytoin Oral Suspension because the purified water used in manufacturing 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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0463-2017·2017-02-08

    VistaPharm Recalls Lactulose Solution Due to Potential Bacterial Contamination

    VistaPharm is recalling Lactulose Solution USP because purified water used in manufacturing 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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0462-2017·2017-02-08

    VistaPharm Recalls Lactulose Solution Due to Potential Bacterial Contamination

    VistaPharm is recalling Lactulose Solution because the purified water used in manufacturing 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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0467-2017·2017-02-08

    VistaPharm Recalls Methadone Hydrochloride Oral Concentrate Due to Water Contamination

    VistaPharm is recalling 3,354 bottles of Methadone Hydrochloride Oral Concentrate because the purified water used in manufacturing 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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0461-2017·2017-02-08

    VistaPharm Recalls Nystatin Oral Suspension Due to Water Contamination

    VistaPharm is recalling Nystatin Oral Suspension because the purified water used in manufacturing 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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0457-2017·2017-02-08

    VistaPharm Recalls Nystatin Oral Suspension Due to Potential Water Contamination

    VistaPharm is recalling Nystatin Oral Suspension because the purified water used in manufacturing 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
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0466-2017·2017-02-08

    VistaPharm Recalls Methadone Hydrochloride Due to Potential Bacterial Contamination

    VistaPharm is recalling Methadone Hydrochloride Oral Concentrate because purified water used in manufacturing may have been contaminated with Burkholderia cepacia.

    Product
    METHADONE HYDROCHLORIDE — METHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0458-2017·2017-02-08

    VistaPharm Recalls Hydrocodone and Acetaminophen Oral Solution Due to Contamination

    VistaPharm is recalling Hydrocodone Bitartrate and Acetaminophen Oral Solution because purified water used in manufacturing 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 o
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0465-2017·2017-02-08

    VistaPharm Recalls Methadone Hydrochloride Due to Potential Bacterial Contamination

    VistaPharm is recalling Methadone Hydrochloride Oral Concentrate because purified water used in manufacturing may have been contaminated with Burkholderia cepacia.

    Product
    METHADONE HYDROCHLORIDE — METHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0459-2017·2017-02-08

    VistaPharm Recalls Metoclopramide Oral Solution Due to Potential Water Contamination

    VistaPharm is recalling specific lots of Metoclopramide Oral Solution because the purified water used in manufacturing 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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0146-2017·2016-11-30

    VistaPharm Recalls Lactulose Solution Due to Bacterial Contamination

    VistaPharm is recalling Lactulose Solution, USP, 10 g/15 mL, because bulk solution tested positive for Burkholderia cepacia bacteria.

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0838-2016·2016-05-11

    VistaPharm Recalls Oxycodone Hydrochloride Oral Solution Due to Defective Container Seals

    VistaPharm is recalling 8,901 cases of Oxycodone Hydrochloride Oral Solution because defective container seals may allow the medication to leak.

    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1831-2015·2015-10-07

    VistaPharm Recalls Metoclopramide Oral Solution Due to Defective Container Lids

    VistaPharm is recalling 84,100 cups of Metoclopramide Oral Solution because the unit dose cup lids 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.
    Category
    Drug
    Distribution
    6 states