CLASS II Drug recall · Reported 10 Mar 2021 · FDA Enforcement Report
Metoclopramide Injection USP, 10 mg/ (5 mg/mL) recalled
Teva Pharmaceuticals USA is recalling Metoclopramide Injection USP, 10 mg/ (5 mg/mL), 25x2mL Single Dose Vials kits, distributed nationwide in the US. The recall was initiated on 15 Feb 2021 and the FDA has classified it as Class II.
Check your package
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-0297-2021
- FDA event ID
- 87330
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Brand
- Metoclopramide
- Manufacturer
- Teva Parenteral Medicines, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Feb 2021
- FDA classified
- 3 Mar 2021
- Reported
- 10 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 15 Feb 2021 | Recall initiated by company | |
| 3 Mar 2021 | Classified by FDA | +16 days |
| 10 Mar 2021 | 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
Chemical contamination; Unknown brown residue adhering to the inside of one vial.
Product as listed by the FDA
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)
Where it was distributed
Nationwide, including Puerto Rico
Questions about this recall
Why was it recalled?
Chemical contamination; Unknown brown residue adhering to the inside of one vial.
Which lots are affected?
Lot # 31325335B, exp. date 07/2021
Where was it sold?
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 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.
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|---|---|---|---|---|---|
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Other Metoclopramide recalls
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metoclopramide Tablets, USP 10 mg recalled by Teva Pharmaceuticals USAMetoclopramide | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Metoclopramide Injection USP, 10 mg/ (5 mg/mL) single-use vial recalledMetoclopramide | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Metoclopramide Injection USP, 10 mg/ (5 mg/mL) Single-Use Vial recalledMetoclopramide | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Metoclopramide Injection USP, 10 mg/ (5 mg/mL) Single-Use recalledMetoclopramide | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Metoclopramide Oral Solution, USP 10 mg/ dose cups recalled | VistaPharm | Sterility | Nationwide |