Quick answers
- What is Metoclopramide used for?
- The FDA-approved label (Reglan, ANI Pharmaceuticals, Inc., February 9, 2026) says: “Reglan tablets are indicated for the: • Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. • Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Limitations of Use …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Metoclopramide have a boxed warning?
- Yes. The FDA label for Reglan has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Metoclopramide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Metoclopramide been recalled?
- FDA enforcement reports list 8 recalls of products of this medicine; the newest started October 6, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Metoclopramide?
- 38 companies list prescription products of Metoclopramide in the FDA NDC Directory, including Bryant Ranch Prepack, NuCare Pharmaceuticals, Inc. and ANI Pharmaceuticals, Inc..
What Metoclopramide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Reglan tablets are indicated for the: • Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. • Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Limitations of Use …
— FDA label: Reglan, ANI Pharmaceuticals, Inc., effective February 9, 2026. Read the full label on DailyMed →
The FDA has 61 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
61 of 61 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| metoclopramide hydrochloride 10 mg tablet | Generic | $0.0432 per tablet |
| metoclopramide hydrochloride 5 mg tablet | Generic | $0.0352 per tablet |
| metoclopramide hydrochloride 5 mg/5 mL solution | Generic | $0.1300 per mL |
| metoclopramide hydrochloride 5 mg/mL injection | Generic | $0.5290 per mL |
| metoclopramide hydrochloride 5 mg/mL injection, solution | Generic | $0.5290 per mL |
NADAC list of November 4, 2026; these prices took effect between July 22, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack8 products
- NuCare Pharmaceuticals, Inc.6 products
- ANI Pharmaceuticals, Inc.5 products
- Cardinal Health 107, LLC4 products
- HF Acquisition Co LLC, DBA HealthFirst3 products
- Medical Purchasing Solutions, LLC3 products
- Remedyrepack Inc.3 products
- American Health Packaging3 products
- Ipca Laboratories Limited2 products
- Atlantic Biologicals Corp.2 products
- Proficient Rx LP2 products
- Hospira, Inc.2 products
- Teva Parenteral Medicines, Inc.2 products
- Coupler LLC2 products
- NCS HealthCare of KY, LLC dba Vangard Labs2 products
- Lupin Pharmaceuticals, Inc.2 products
- Safecor Health LLC2 products
- Mylan Institutional Inc.2 products
- Redpharm Drug2 products
- Teva Pharmaceuticals USA, Inc.2 products
- PAI Holdings, LLC dba PAI Pharma2 products
- Fresenius Kabi USA, LLC2 products
- ScieGen Pharmaceuticals, Inc.2 products
- AvKARE1 product
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 product
- A-S Medication Solutions1 product
- ProPharma Distribution1 product
- Baxter Healthcare Corporation1 product
- Aphena Pharma Solutions - Tennessee, LLC1 product
- Preferred Pharmaceuticals Inc.1 product
- Genus Lifesciences Inc.1 product
- NuCare Pharamceuticals, Inc.1 product
- Northwind Health Company, LLC1 product
- Avenacy, LLC1 product
- Chartwell RX, LLC1 product
- Henry Schein, Inc.1 product
- Chartwell Governmental & Specialty RX, LLC.1 product
- Evoke Pharma, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA017854 REGLAN | Ani Pharms | December 30, 1980 | 52, latest February 9, 2026 2026: Labeling · 2017: Labeling · 2015: Manufacturing (CMC) |
| NDA209388 GIMOTI | Qol Medcl | June 19, 2020 | 2, latest February 9, 2026 2026: Labeling · 2021: Labeling |
Generic approvals (13)
- ANDA070184Teva · July 29, 1985
- ANDA072215Aiping Pharm Inc · January 30, 1990
- ANDA073118Hospira · January 17, 1991
- ANDA072744Pai Holdings · May 28, 1991
- ANDA073135Teva Pharms USA · November 27, 1991
- ANDA073680Chartwell Molecular · October 27, 1992
- ANDA072801Teva · June 15, 1993
- ANDA071402Ani Pharms · June 25, 1993
- ANDA078807Ipca Labs Ltd · June 12, 2008
- ANDA091392Fresenius Kabi USA · April 19, 2013
- ANDA204756Avet Lifesciences · December 20, 2013
- ANDA202191Novel Labs Inc · August 15, 2014
- ANDA217072Baxter Hlthcare Corp · September 11, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
October 6, 2026 · Class II · Ongoing · D-0042-2027
Presence of Foreign Tablets/Capsules
Metoclopramide Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-620-01; NDC Unit Dose: 60687-620-11 — American Health Packaging
-
September 29, 2026 · Class II · Ongoing · D-0038-2027
Presence of Foreign Tablets/Capsules
Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC 100 Tablets: 0093-2204-01; NDC 500 Tablets: 0093-2204-05 — Teva Pharmaceuticals USA, Inc
-
May 23, 2025 · Class II · Ongoing · D-0473-2025
Presence of foreign tablets/capsules.
Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb, Croatia, Manufactured for Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 0093-2203-01. — Teva Pharmaceuticals USA, Inc
-
July 29, 2021 · Class II · Terminated · D-0741-2021
Lack of Assurance of Sterility
Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-4502-01 — Teva Pharmaceuticals USA
-
April 26, 2021 · Class II · Terminated · D-0377-2021
Lack of Assurance of Sterility
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx Only, TEVA Parenteral Medicines, Inc. Irvine, CA 92618 NDC 0703-4502-04 — Teva Pharmaceuticals USA
-
February 15, 2021 · Class II · Terminated · D-0297-2021
Chemical contamination; Unknown brown residue adhering to the inside of one vial.
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials, Rx only, Distributed by Teva Pharmaceuticals, USA, Inc., Parsippany, NJ Vial NDC 0703-4502-01 (vial) NDC# 0703-4502-04 (tray) — Teva Pharmaceuticals USA
-
February 10, 2021 · Class II · Terminated · D-0277-2021
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial NDC 0703-4502-01), packaged in 25 x 2 mL Single-Use Vials per tray (NDC 0703-4502-04), Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618. — Teva Pharmaceuticals USA
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September 24, 2013 · Class II · Terminated · D-012-2014
Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Metoclopramide Injection, USP 10 mg (5mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-3414-01 — Hospira Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Reglan, ANI Pharmaceuticals, Inc., effective February 9, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →