CLASS III Drug recall · Reported 5 Sep 2012 · FDA Enforcement Report

Metoclopramide Oral Solution, USP 5 mg/, This cup delivers recalled

VistaPharm is recalling Metoclopramide Oral Solution, USP 5 mg/, This cup delivers, distributed nationwide in the US. The recall was initiated on 19 Jan 2011 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codes195900 exp. 01/12.

Quantity recalled73,800 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-1669-2012
FDA event ID: 62887
Recalling firm: VistaPharm, Largo, FL
Classification: Class III
Status: Terminated
Recall initiated: 19 Jan 2011
FDA classified: 29 Aug 2012
Reported: 5 Sep 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Drug class: Stomach & Acid Reflux Medication

Timeline

19 Jan 2011	Recall initiated by company
29 Aug 2012	Classified by FDA	+588 days
5 Sep 2012	Published in enforcement report	+7 days

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

Reason for recall

Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," instead of "10 mL x 50,"

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, This cup delivers 10 mL, Rx Only, Manufactured by VistaPharm, Inc., Largo FL33771

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," instead of "10 mL x 50,"

Which lots are affected?

195900 exp. 01/12.

Where was it sold?

Nationwide

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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.

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
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Other Metoclopramide recalls

All 12

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 USA	Sterility	Nationwide
26 May 2021Drug	CLASS II	Metoclopramide Injection USP, 10 mg/ (5 mg/mL) Single-Use Vial recalledMetoclopramide	Teva Pharmaceuticals USA	Sterility	Nationwide
10 Mar 2021Drug	CLASS II	Metoclopramide Injection USP, 10 mg/ (5 mg/mL) recalledMetoclopramide	Teva Pharmaceuticals USA	Other	Nationwide
3 Mar 2021Drug	CLASS II	Metoclopramide Injection USP, 10 mg/ (5 mg/mL) Single-Use recalledMetoclopramide	Teva Pharmaceuticals USA	Sterility	Nationwide