CLASS II Drug recall · Reported 9 Aug 2017 · FDA Enforcement Report

Lactulose Solution, USP, dose cups delivers recalled by VistaPharm

VistaPharm is recalling Lactulose Solution, USP, dose cups delivers, distributed in 7 states. The recall was initiated on 26 Jun 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 468300, Exp 09/2018; 474400, Exp 11/2018

Quantity recalled6150 cases

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1052-2017
FDA event ID: 77638
Recalling firm: VistaPharm, Largo, FL
Classification: Class II
Status: Terminated
Recall initiated: 26 Jun 2017
FDA classified: 1 Aug 2017
Reported: 9 Aug 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Mold

Timeline

26 Jun 2017	Recall initiated by company
1 Aug 2017	Classified by FDA	+36 days
9 Aug 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.

Product as listed by the FDA

Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-50

Where it was distributed

CA, IL, LA, NH, OH, PA, SC

California Illinois Louisiana New Hampshire Ohio Pennsylvania South Carolina

Questions about this recall

Why was it recalled?

Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.

Which lots are affected?

Lot #: 468300, Exp 09/2018; 474400, Exp 11/2018

Where was it sold?

CA, IL, LA, NH, OH, PA, SC

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 77638

Reported	Class	Recall	Company	Reason	Where
9 Aug 2017	CLASS II	Lactulose Solution, USP, dose cups delivers packaged dose cups recalled	VistaPharm	Mold	7 states

More recalls from VistaPharm

All 36

Reported	Class	Recall	Company	Reason	Where
6 Dec 2023Drug	CLASS III	Aminocaproic Acid Oral Solution/mL recalled by VistaPharm	VistaPharm	Packaging Defects	Nationwide
15 Nov 2023Drug	CLASS III	Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL recalled	VistaPharm	Other	Nationwide
25 Oct 2023Drug	CLASS I	Sucralfate Oral Suspension per PET bottle) recalled by VistaPharmSucralfate	VistaPharm	Other Bacterial Contamination	Nationwide
20 Sep 2023Drug	CLASS II	Sucralfate Oral Suspension per, For Oral Administration Only bottle) recalledSucralfate	VistaPharm	Potency & Assay	Nationwide
2 Nov 2022Drug	CLASS II	Pyridostigmine Bromide Oral Solution, USP 60 mg/ Delivers recalledPyridostigmine Bromide	VistaPharm	Potency & Assay	Nationwide

Other Lactulose recalls

All 9

Reported	Class	Recall	Company	Reason	Where
7 Jun 2023Drug	CLASS II	Lactulose Solution, USP (Oral) recalled by Akorn	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Lactulose Solution, USP (For oral or rectal administration) recalled	Akorn	Potency & Assay	Nationwide
19 Jun 2019Drug	CLASS II	Lactulose Solution, USP, For Oral Administration recalled	Torrent Pharma	Sterility	Nationwide
19 Jun 2019Drug	CLASS II	Lactulose Solution, USP, For Oral or Rectal Administration recalled	Torrent Pharma	Sterility	Nationwide
9 Aug 2017Drug	CLASS II	Lactulose Solution, USP, dose cups delivers packaged dose cups recalled	VistaPharm	Mold	7 states