CLASS II Drug recall · Reported 25 Aug 2021 · FDA Enforcement Report
Metoclopramide Injection USP, 10 mg/ (5 mg/mL) single-use vial recalled
Teva Pharmaceuticals USA is recalling Metoclopramide Injection USP, 10 mg/ (5 mg/mL) single-use vial, distributed nationwide in the US. The recall was initiated on 29 Jul 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-0741-2021
- FDA event ID
- 88442
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Brand
- Metoclopramide
- Manufacturer
- Teva Parenteral Medicines, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jul 2021
- FDA classified
- 16 Aug 2021
- Reported
- 25 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 29 Jul 2021 | Recall initiated by company | |
| 16 Aug 2021 | Classified by FDA | +18 days |
| 25 Aug 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Product was distributed Nationwide, including Puerto Rico.
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot #: 31326043B, exp. date 10/2021; 31326138B, exp. date 11/2021 31329399B, 31329539B, exp. date 08/2023; 31329599B, exp. date 09/2023
Where was it sold?
Product was distributed 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.
Other products in this recall event
18 other products · FDA event 88442This product is part of a recall event; the main page for the event is Epoprostenol Sodium for Injection, 1.5 mg/vial vials recalled.
More recalls from Teva Pharmaceuticals USA
All 280| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) recalledClaravis | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
| Drug | CLASS II | Isotretinoin Capsules, USP, 40 mg Prescription Pacs recalledIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
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) recalledMetoclopramide | Teva Pharmaceuticals USA | Other | 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 |