VistaPharm Recalls Lactulose Solution Due to Potential Bacterial Contamination
VistaPharm is recalling Lactulose Solution because the purified water used in manufacturing may have been contaminated with Burkholderia cepacia.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for potential serious temporary or medically reversible health consequences.
Plain-English summary
VistaPharm, Inc. is recalling Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case. The recall involves 18,437 unit dose cups distributed nationwide. The specific lots affected are 422800, 430500, 424000, 412500, 405500, and 414900.
The recall was initiated because the purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. This is a Current Good Manufacturing Practice (CGMP) deviation.
Patients and healthcare providers should discontinue use of the recalled product and contact their healthcare provider for alternative treatment options. The recalling firm is VistaPharm, Inc.
The recalled product
- Product
- Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-038-50.
- Manufacturer
- VistaPharm, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 18,437
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot No. 422800 (1Exp. 0/17)
- 430500 (Exp. 12/17)
- 424000 (Exp. 10/17)
- 412500 (Exp. 07/17)
- 405500 (Exp. 05/17)
- 414900 (Exp. 09/17)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by VistaPharm, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
Same manufacturer · VistaPharm, Inc.
See all →- ModeratePrescription pyridostigmine bromide oral solution recalled for out-of-specification preservative
FDA (Drugs) · 2022-11-02
- ModerateClobazam Oral Suspension Recalled for Failed Stability Specifications
FDA (Drugs) · 2022-01-26
- LowVistaPharm Recalls Nystatin Oral Suspension Due to Impurity
FDA (Drugs) · 2020-10-14
- LowVistaPharm Recalls Nystatin Oral Suspension Due to Impurity Exceeding Specifications
FDA (Drugs) · 2020-07-15
- LowVistaPharm Recalls Nystatin Oral Suspension Due to Impurity Peak
FDA (Drugs) · 2020-07-15
Same hazard · bacterial contamination
See all →- HighClorox Recalls Scented Mistolin and Lestoil Cleaners in Puerto Rico
CPSC · 2026-09-03
- HighCurry chicken salad flagged for possible Listeria contamination in two states
USDA FSIS · 2026-07-30
- ModerateMedline Medical Convenience Kits Recalled Due to Potential Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighMedline Convenience Kits Recalled Over Bacillus Contamination
FDA (Devices) · 2026-07-29
- SevereSurgical Convenience Kit Recalled for Bacterial Contaminant in Alcohol Prep Pads
FDA (Devices) · 2026-07-08