Largo, FL, United States
VistaPharm, Inc. recalls
9 recalls recorded since 2018, most recently on 26 October 2023. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls9
Ongoing (FDA)0
Terminated or completed9
Class I (FDA)1
Terminated Class III Drugs
- Recall started
- 26 October 2023
- Terminated
- 21 March 2025
- Reason
- Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
- Distribution
- Nationwide and Saudi Arabia
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0093-2024
- Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#66689-307-08.
Terminated Class I Drugs
- Recall started
- 18 October 2023
- Terminated
- 30 April 2024
- Reason
- Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0047-2024
- 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
Terminated Class III Drugs
- Recall started
- 17 October 2023
- Terminated
- 26 July 2024
- Reason
- Failed Excipient Specifications: high content of ethylene glycol (EG)
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0126-2024
- Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for: VistaPharm, Inc., Largo, FL 33771, UAS, NDC 66689-330-08
Terminated Class II Drugs
- Recall started
- 30 August 2023
- Terminated
- 26 July 2024
- Reason
- Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
- Distribution
- Distributed nationwide to 68 consignees in the U.S.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1149-2023
- 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
Terminated Class II Drugs
- Recall started
- 30 September 2022
- Terminated
- 30 April 2024
- Reason
- cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0018-2023
- 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
Terminated Class II Drugs
- Recall started
- 7 January 2022
- Terminated
- 13 December 2024
- Reason
- Failed Stability Specifications
- Distribution
- Nationwide within the United States including Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0376-2022
- Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-058-04
Terminated Class III Drugs
- Recall started
- 25 September 2020
- Terminated
- 28 September 2022
- Reason
- Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
- Distribution
- Distributed Nationwide in the USA including Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0019-2021
- 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,
Terminated Class III Drugs
- Recall started
- 23 June 2020
- Terminated
- 28 September 2022
- Reason
- Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
- Distribution
- United States including Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1377-2020, D-1378-2020
- 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.
- 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.
Terminated Class III Drugs
- Recall started
- 30 November 2018
- Terminated
- 25 November 2020
- Reason
- Failed Impurities/Degradation Specifications:Out of specification for impurities.
- Distribution
- Nationwide in the USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0348-2019
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.