VistaPharm, Inc.

FDA Regulatory Profile

VistaPharm, Inc. has 36 FDA recalls (1 Class I), 11 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest recall
D-0093-2024 · Class III · Oct 26, 2023
Latest inspection
Apr 17, 2024 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls36 (1 Class I)Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections11Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
D-0093-2024Class IIIMycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for…Oct 26, 2023
D-0047-2024Class ISucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only…Oct 18, 2023
D-0126-2024Class IIIAminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE…Oct 17, 2023
D-1149-2023Class IISucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only…Aug 30, 2023
D-0018-2023Class IIPyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup…Sep 30, 2022
D-0376-2022Class IIClobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc…Jan 7, 2022
D-0019-2021Class IIINYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored)…Sep 25, 2020
D-1377-2020Class IIINystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by…Jun 23, 2020
D-1378-2020Class IIINystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL)…Jun 23, 2020
D-0348-2019Class IIINYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose…Nov 30, 2018
D-1139-2017Class IIIHydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored)…Aug 17, 2017
D-1052-2017Class IILactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per…Jun 26, 2017
D-1053-2017Class IILactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case…Jun 26, 2017
D-0869-2017Class IIINystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC…May 17, 2017
D-0467-2017Class IIMethadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per case, Rx only…Jan 18, 2017
D-0459-2017Class IIMetoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL per case, Rx only…Jan 18, 2017
D-0458-2017Class IIHydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz…Jan 18, 2017
D-0460-2017Class IIPhenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case., Rx only…Jan 18, 2017
D-0457-2017Class IINystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC…Jan 18, 2017
D-0464-2017Class IIOxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5 mL per case…Jan 18, 2017

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 17, 2024Largo, FLDrugsNo Action Indicated (NAI)1036352
Sep 2, 2022Largo, FLDrugsOfficial Action Indicated (OAI)1036352
Jan 16, 2018Largo, FLDrugsVoluntary Action Indicated (VAI)1036352
Nov 9, 2017Largo, FLDrugsNo Action Indicated (NAI)1036352
Dec 13, 2016Largo, FLDrugsVoluntary Action Indicated (VAI)1036352
May 28, 2015Largo, FLDrugsVoluntary Action Indicated (VAI)1036352
Jun 15, 2012Largo, FLDrugsVoluntary Action Indicated (VAI)1036352
Jun 15, 2012Largo, FLDrugsVoluntary Action Indicated (VAI)1036352
Mar 1, 2010Largo, FLDrugsNo Action Indicated (NAI)1036352
Jun 19, 2009Largo, FLDrugsVoluntary Action Indicated (VAI)1036352
Jun 19, 2009Largo, FLDrugsVoluntary Action Indicated (VAI)1036352

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 1036352Largo, FL11Apr 17, 2024

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.