Lower risk Drug recall · FDA · Published September 30, 2022

VistaPharm Pyridostigmine Bromide Oral Solution Recall: Preservative Issue

VistaPharm recalls Pyridost: 60 mg/5mL oral solution with preservative out of spec. This medication may not be safe for use. Check NDC 66689-406-01, lot 832400, exp 08/2023.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0018-2023Drug VistaPharm ›

Lower-risk recall

cGMP Deviations: Out of specification for assay of one of the preservative ingredients.

Take action

Contact the company

Recalling firmVistaPharm, Inc.7265 Ulmerton Rd · Largo, FL 33771-4809

✎ GovInfoNow plain-language explainer

VistaPharm is recalling Pyridostigmine Bromide Oral Solution (60 mg/5 mL) due to a preservative ingredient not meeting quality standards. This could affect medication safety for people using this prescription drug. Read more at govinfonow.com/recall/34309-vistapharm-pyridostigmine-bromide-oral-solution-recall-preservative-issue.

Source Summary by GovInfoNow · govinfonow.com/recall/34309-vistapharm-pyridostigmine-bromide-oral-solution-recall-preservative-issue · Updated August 18, 2026 · FDA enforcement record: FDA #D-0018-2023

Cite this page

“VistaPharm Pyridostigmine Bromide Oral Solution Recall: Preservative Issue.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34309-vistapharm-pyridostigmine-bromide-oral-solution-recall-preservative-issue. Based on FDA recall #D-0018-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0018-2023%22&limit=1).

The FDA announced on September 30, 2022, that VistaPharm, Inc. is recalling Pyridostigmine Bromide Oral Solution due to cGMP deviations involving out-of-specification assay results for a preservative ingredient. The recall affects 1,980 unit-dose cups distributed nationwide.

How to tell if you have it

Brand: VistaPharm
Product: Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL
Packaging: 5mL unit-dose cup
NDC: 66689-406-01
Lot#: 832400
Expiration: 08/2023

The hazard

The recall is due to cGMP deviations where one of the preservative ingredients was found to be out of specification for its assay. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show VistaPharm, Inc. has had 19 other recalls on record since January 19, 2011. Other recent recalls of similar products include VistaPharm Clobazam Oral Suspension (January 7, 2022) and VistaPharm NYSTATIN Oral Suspension (September 25, 2020). Additional similar product recalls include VistaPharm Activated Charcoal Drink (May 15, 2026).

How to tell if you have this one

Check the product label for the NDC code 66689-406-01 and lot number 832400. The expiration date is August 2023.

Brand
VistaPharm
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the NDC code 66689-406-01 and lot number 832400 on the product label.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 19 months after the firm started it.

Sep 30, 2022Firm started the recall
Oct 21, 2022FDA classified it Class II
Nov 2, 2022Published in FDA’s Enforcement Report
Apr 30, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/34309-vistapharm-pyridostigmine-bromide-oral-solution-recall-preservative-issue">VistaPharm Pyridostigmine Bromide Oral Solution Recall: Preservative Issue (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0018-2023 (September 30, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0018-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.