VistaPharm Recalls
36 recalls on record · July 18, 2012 to December 6, 2023 · Drugs
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 6, 2023DrugsFDA
VistaPharm LLC recalls Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for
Hazard: Failed Excipient Specifications: high content of ethylene glycol (EG)
November 15, 2023DrugsFDA
VistaPharm LLC recalls Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, F
Hazard: Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
October 25, 2023DrugsFDA
VistaPharm LLC recalls Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Dist
Hazard: Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
September 20, 2023DrugsFDA
VistaPharm LLC recalls Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distribu
Hazard: Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
November 2, 2022DrugsFDA
VistaPharm, Inc. recalls Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: Vi
Hazard: cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
January 26, 2022DrugsFDA
VistaPharm, Inc. recalls Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771, NDC 666
Hazard: Failed Stability Specifications
October 14, 2020DrugsFDA
VistaPharm, Inc. recalls NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL)
Hazard: Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
July 15, 2020DrugsFDA
VistaPharm, Inc. recalls Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Us
Hazard: Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
July 15, 2020DrugsFDA
VistaPharm, Inc. recalls Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 337
Hazard: Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
December 26, 2018DrugsFDA
VistaPharm, Inc. recalls NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose
Hazard: Failed Impurities/Degradation Specifications:Out of specification for impurities.
September 20, 2017DrugsFDA
VistaPharm, Inc. recalls Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx onl
Hazard: Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
August 9, 2017DrugsFDA
VistaPharm, Inc. recalls Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case, Manufactured by Vist
Hazard: Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
August 9, 2017DrugsFDA
VistaPharm, Inc. recalls Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufactured by Vi
Hazard: Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
June 7, 2017DrugsFDA
VistaPharm, Inc. recalls Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000
Hazard: Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
February 15, 2017DrugsFDA
VistaPharm, Inc. recalls Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15 mL unit dose cups (NDC 66689-047-01), 50 u
Hazard: Defective Container: Leakage of unit dose cups that may occur at the seal.
February 8, 2017DrugsFDA
VistaPharm, Inc. recalls Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per case, Rx only, Manufactured by Vista
Hazard: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
February 8, 2017DrugsFDA
VistaPharm, Inc. recalls Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000 mL), 4 bottles per case, Rx only
Hazard: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
February 8, 2017DrugsFDA
VistaPharm, Inc. recalls Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (30 mL), 12 bottles per case (NDC No. 66689-6
Hazard: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
February 8, 2017DrugsFDA
VistaPharm, Inc. recalls 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
Hazard: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
February 8, 2017DrugsFDA
VistaPharm, Inc. recalls Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL
Hazard: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
February 8, 2017DrugsFDA
VistaPharm, Inc. recalls Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL
Hazard: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
February 8, 2017DrugsFDA
VistaPharm, Inc. recalls 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
Hazard: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
February 8, 2017DrugsFDA
VistaPharm, Inc. recalls Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case., Rx only, Manufactured by VistaPharm, L
Hazard: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
February 8, 2017DrugsFDA
VistaPharm, Inc. recalls Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL per case, Rx only, Manufactured by VistaPharm
Hazard: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
February 8, 2017DrugsFDA
VistaPharm, Inc. recalls Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles
Hazard: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
February 8, 2017DrugsFDA
VistaPharm, Inc. recalls 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
Hazard: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
November 30, 2016DrugsFDA
VistaPharm, Inc. recalls 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
Hazard: Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
May 11, 2016DrugsFDA
VistaPharm, Inc. recalls Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-01), shrink- wrapped in 10 unit dose cups x
Hazard: Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.
October 7, 2015DrugsFDA
VistaPharm, Inc. recalls METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only. Manufactured by VistaPharm, Inc, Largo, FL. NDC: 666
Hazard: Defective Container: Lids on unit dose cups are not fully qualified.
October 15, 2014DrugsFDA
VistaPharm, Inc. recalls METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, (present as the hydrochloride), 10 mL cups, Rx only. Manufactured by VistaP
Hazard: Defective Container: Product leaks when inverted.