Drug recall: NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL)…

Class III FDA enforcement event 86486. Recall start date: 25 Sep 2020. Status in the FDA record: Terminated. Termination date: 28 Sep 2022.

Reason for recall, in the words of FDA

Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot

Class III, in the words of FDA

a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

VistaPharm, Inc. started this drug recall on 25 Sep 2020. The firm address in the FDA record is in Largo, FL. FDA put the recall in Class III. FDA event 86486 has 1 product record. The first FDA enforcement report date is 14 Oct 2020. The record gives the status Terminated, with the termination date 28 Sep 2022.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Distributed Nationwide in the USA including Puerto Rico

Recalling firm

VistaPharm, Inc., Largo, FL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 86486: product records
Recall number	Product	Quantity	Class	Status	Report date
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,	14,244 16 oz bottles	Class III	Terminated	14 Oct 2020

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class III: The lowest of the three FDA recall classes.

The event in context

Drug events that started in 2020: 342
Share of these events in Class III: 21%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 20

Other events of the firm

Other FDA enforcement events of VistaPharm, Inc.
Initiated	Product (first record)	Type	Class	Records
30 Sep 2022	Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: Vi	Drug	Class II	1
7 Jan 2022	Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771, NDC 6668	Drug	Class II	1
23 Jun 2020	Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 3377	Drug	Class III	2
30 Nov 2018	NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose	Drug	Class III	1
17 Aug 2017	Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx onl	Drug	Class III	1
26 Jun 2017	Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufactured by Vi	Drug	Class II	2
17 May 2017	Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000	Drug	Class III	1
18 Jan 2017	Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15 mL unit dose cups (NDC 66689-047-01), 50 un	Drug	Class II	1
18 Jan 2017	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	Drug	Class II	11
9 Nov 2016	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	Drug	Class II	1

VistaPharm, Inc.: all 20 events

Official channels

FDA enforcement report D-0019-2021The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 86486. https://recallregister.com/fda/iii/86486/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Distributed Nationwide in the USA including Puerto Rico
What quantity of product is in FDA event 86486?: The FDA record gives this quantity: 14,244 16 oz bottles
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2020 have the same class?: 21% of the 342 drug events that started in 2020 are in Class III.