VistaPharm Metoclopramide Oral Solution Recall: Water Contamination Risk
VistaPharm recalls Metoclopramide Oral Solution (10 mg/10 mL) due to potential Burkholderia cepacia contamination in purified water used during manufacturing. This recall affects specific lots and requires immediate action.
Recall notice
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Contact the company
What happened, in plain English
VistaPharm is recalling Metoclopramide Oral Solution (10 mg/10 mL) because purified water used in manufacturing may contain Burkholderia cepacia bacteria. This could pose a health risk to patients using the medication. Read more at govinfonow.com/recall/42075-vistapharm-metoclopramide-oral-solution-recall-water-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42075-vistapharm-metoclopramide-oral-solution-recall-water-contamination-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0459-2017
Cite this page
“VistaPharm Metoclopramide Oral Solution Recall: Water Contamination Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42075-vistapharm-metoclopramide-oral-solution-recall-water-contamination-risk. Based on FDA recall #D-0459-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0459-2017%22&limit=1).
Why it’s dangerous
The recall is due to potential contamination of purified water used in manufacturing, which may introduce Burkholderia cep: a bacterium that can cause infections. This risk is specific to the recalled lots and does not apply to all products.
Who’s affected
Patients prescribed Metoclopramide Oral Solution by a doctor are affected. Those using the recalled lot numbers are at risk of potential contamination.
How to tell if you have this one
Check the product label for the lot number: 428700 (expires November 2017) or 409500 (expires June 2017). The product is a prescription-only oral solution in 50 unit dose cups.
- Brand
VistaPharm- Category
Drug
All 11 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0457-2017 | 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 fl. oz. (237 mL), 12 bottles per case (NDC 66689-008-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771; a) Lot No. 422600 (Exp. 10/17), 420000 (Exp. 09/17), 416100 (Exp. 08/17), 417400 (Exp. 09/17) b) Lot No. 424200 (Exp. 10/17), 415500 (Exp. 03/18) | 67,955 bottles | — |
| D-0458-2017 | Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles per case (NDC 66689-023-04), b) 16 fl.oz. (473 mL), 12 bottles per case (NDC 66689-023-16), c) 50 unit dose cups of 15 mL per case, (NDC No. 66689-023-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771; a). Lot No. 419000 (Exp. 03/17) b.) Lot No. 419800 (Exp. 03/17), 429100 (Exp. 06/17) c). Lot No. 418200 (Exp. 03/17), 430100 (Exp. 06/17), 423800 (Exp. 04/17), 413100 (Exp. 02/17), 410700 (Exp. 01/17) | 32,027 bottles and 16,310 unit dose cups | — |
| D-0459-2017 | Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-031-50.; Lot No. 428700 (Exp. 11/17), 409500 (Exp.06/17) | 3,496 unit dose cups | — |
| D-0460-2017 | Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case., Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-036-50.; Lot No. 428700 (Exp. 11/17), 409500 (Exp. 06/17) | 12,059 unit dose cups | — |
| D-0461-2017 | Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 mL per case (NDC No. 66689-037-50), b). 100 unit dose cups of 5 mL per case (NDC 66689-037-99), Rx only, Manufactured by VistaPharm, Largo, FL 33771.; a). Lot No. 428900, 425600 (Exp. 05/17); 421200 (Exp. 04/17), 413600 (Exp. 02/17), 411500 (Exp. 01/17), 417200 (Exp. 03/17) b). Lot No. 429300 (Exp. 06/17) ,426500 (Exp. 05/17), 420600 (Exp. 03/17), 417000 (Exp.03/17), 412900 (Exp. 01/17), 409900 (Exp. 01/17) | 55,191 unit dose cups | — |
| D-0462-2017 | 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.; 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) | 18,437 unit dose cups | — |
| D-0463-2017 | Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-039-50.; a). Lot No. 728300 (Exp. 11/17), 423200 (Exp. 10/17), 418400 (Exp. 09/17), 411100 (Exp. 07/17), 406500 (Exp. 06/17) | 7,404 unit dose cups | — |
| D-0464-2017 | Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5 mL per case (NDC No. 66689-401-50), b). 500 mL, 12 bottles per case (NDC No. 66689-403-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771.; a). Lot No. 427900, 426700 (Exp. 11/17), 424800, 423600 (Exp. 10/17), 420800 (09/17), 416300 (08/17), 407700, 407300 (Exp. 06/17), 405900, 403900 (Exp. 05/17) b). Lot No. 426900 (Exp. 11/17), 404700 (Exp. 05/17), 390200 (Exp. 02/17) | 42,776 unit dose cups and 17,403 bottles | — |
| D-0465-2017 | Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (30 mL), 12 bottles per case (NDC No. 66689-695-30), b). 1 liter (1000 mL), 4 bottles per case, (NDC No. 66689-695-79), Rx only, Manufactured by VistaPharm, Largo, FL 33771.; a). Lot No. 416600 (Exp. 09/17) b). Lot No.449100 , 447500 (Exp. 04/18), 421800 (Exp. 10/17), 418600 (Exp. 09/17), 408700 (Exp. 06/17), 411900 (Exp. 07/17), 413800 (Exp. 08/17), 416500 (Exp. 09/17), 408500 (Exp. 06/17), 389800 (Exp. 01/17), 429900 (Exp. 12/17), 406300, 406100 (Exp. 05/17), 429700 (Exp. 12/17), 427300, 427100, 425900 (11/17) | 127,193 bottles | 66689-694-30, 66689-694-79, 66689-694-88, 66689-695-79, 66689-695-30 |
| D-0466-2017 | Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000 mL), 4 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-695-79.; Lot No. 423000 (Exp. 10/17), 415100 (Exp. 08/17) | 14,368 bottles | 66689-694-30, 66689-694-79, 66689-694-88, 66689-695-79 |
| D-0467-2017 | Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-711-16.; Lot No. 388700 (Exp. 01/17) | 3,354 bottles | — |
What to do — step by step
Check Product Lot Number
Look for the lot number on the label: 428700 (expires November 2017) or 409500 (expires June 2017).
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “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 4.6 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0459-2017 (January 18, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0459-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.