CLASS II Drug recall · Reported 15 Oct 2014 · FDA Enforcement Report

Metoclopramide Oral Solution, USP 5 mg recalled by VistaPharm

VistaPharm is recalling Metoclopramide Oral Solution, USP 5 mg/, (present as the hydrochloride) cups, distributed nationwide in the US. The recall was initiated on 13 Aug 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 283700, Expiry: 11/14; Lot #: 291400, Expiry: 01/15; and Lot #: 303500, Expiry: 04/15.

Quantity recalled322,650 Cups

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-0010-2015
FDA event ID: 69250
Recalling firm: VistaPharm, Largo, FL
Classification: Class II
Status: Terminated
Recall initiated: 13 Aug 2014
FDA classified: 9 Oct 2014
Reported: 15 Oct 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Drug class: Stomach & Acid Reflux Medication

Timeline

13 Aug 2014	Recall initiated by company
9 Oct 2014	Classified by FDA	+57 days
15 Oct 2014	Published in enforcement report	+6 days

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

Reason for recall

Defective Container: Product leaks when inverted.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, (present as the hydrochloride), 10 mL cups, Rx only. Manufactured by VistaPharm Inc., Largo, FL 33771. NDC 66689-031-01.

Where it was distributed

U.S. Nationwide, including Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Is Metoclopramide Oral Solution, USP 5 mg/, (present as the hydrochloride) cups recalled?

Yes. VistaPharm recalled Metoclopramide Oral Solution, USP 5 mg/, (present as the hydrochloride) cups on 13 Aug 2014. The recall is Class II and its status is Terminated. Recall number D-0010-2015.

Why was it recalled?

Defective Container: Product leaks when inverted.

Which lots are affected?

Lot #: 283700, Expiry: 11/14; Lot #: 291400, Expiry: 01/15; and Lot #: 303500, Expiry: 04/15.

Where was it sold?

U.S. Nationwide, including Puerto Rico

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

More recalls from VistaPharm

All 36

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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 recalledMycophenolate Mofetil	VistaPharm	Other	Nationwide
25 Oct 2023Drug	CLASS I	Sucralfate Oral Suspension per PET bottle) recalled by VistaPharmSucralfate	VistaPharm	Sterility	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 Metoclopramide recalls

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Reported	Class	Recall	Company	Reason	Where
2 Jul 2025Drug	CLASS II	Metoclopramide Tablets, USP 10 mg recalled by Teva Pharmaceuticals USAMetoclopramide	Teva Pharmaceuticals USA	Other	Nationwide
25 Aug 2021Drug	CLASS II	Metoclopramide Injection USP, 10 mg/ (5 mg/mL) single-use vial recalledMetoclopramide	Teva Pharmaceuticals U	Sterility	Nationwide
26 May 2021Drug	CLASS II	Metoclopramide Injection USP, 10 mg/ (5 mg/mL) Single-Use Vial recalledMetoclopramide	Teva Pharmaceuticals U	Sterility	Nationwide
10 Mar 2021Drug	CLASS II	Metoclopramide Injection USP, 10 mg/ (5 mg/mL) recalledMetoclopramide	Teva Pharmaceuticals U	Other	Nationwide
3 Mar 2021Drug	CLASS II	Metoclopramide Injection USP, 10 mg/ (5 mg/mL) Single-Use Vial recalledMetoclopramide	Teva Pharmaceuticals U	Sterility	Nationwide