The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0741-2021·Announced 2021-08-25

Metoclopramide Injection Vials Recalled for Lack of Sterility Assurance

Teva Pharmaceuticals USA is recalling 25,653 vials of Metoclopramide Injection USP due to lack of assurance of sterility. The affected vials were distributed nationwide, including Puerto Rico.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall. Lack of sterility assurance in injectable medications poses a significant risk of infection and harm, particularly in a parenteral route of administration. While no specific illnesses or hospitalizations are reported in the source text, the class designation and inherent risk of non-sterile injected products meet the Severe threshold.

Plain-English summary

Teva Pharmaceuticals USA is recalling Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) in 2 mL single-use vials. The recall affects 25,653 vials due to lack of assurance of sterility.

The affected product was distributed nationwide, including Puerto Rico. The recalled lot numbers are: 31326043B (expiration date 10/2021), 31326138B (expiration date 11/2021), 31329399B (expiration date 08/2023), 31329539B (expiration date 08/2023), and 31329599B (expiration date 09/2023). The NDC is 0703-4502-01.

Patients and healthcare providers who have this medication should not use the affected vials and should contact Teva Pharmaceuticals USA or consult with their healthcare provider regarding the recall.

The recalled product

Product
METOCLOPRAMIDE (METOCLOPRAMIDE)
Brand
METOCLOPRAMIDE
Manufacturer
Teva Pharmaceuticals USA
Category
Drug — Injectable / Parenteral
Hazard
Affected units
25,653

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • Lot #: 31326043B
  • exp. date 10/2021
  • 31326138B
  • exp. date 11/2021 31329399B
  • 31329539B
  • exp. date 08/2023
  • 31329599B
  • exp. date 09/2023

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 19 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 19 products in this recall →

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Same hazard · sterility assurance failure

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