The Recall Desk
SevereFDA (Drugs)·D-0277-2021·Announced 2021-03-03

Teva Recalls Metoclopramide Injection Due to Sterility Concerns

Teva Pharmaceuticals is recalling Metoclopramide Injection because manufacturing areas exceeded microbial acceptance levels, creating a lack of sterility assurance.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a sterile injectable product with a lack of sterility assurance (implying significant injury risk) corresponds to a severity score of 4 (Severe).

Plain-English summary

Teva Pharmaceuticals USA is recalling specific lots of Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vials. The recall involves 29,357 vials distributed nationwide in the USA and Puerto Rico. The affected lots are 31325042B, 31325336B, 31326042B, 31326137B, 31326230B, and 31323816B, with expiration dates ranging from February 2021 to December 2021.

The recall was initiated due to a lack of assurance of sterility. The source text states that manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery, which led to a lack of sterility assurance for these sterile injectable products.

Healthcare providers and patients should check their inventory and medication records for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, it should not be used. Consumers and healthcare professionals should contact Teva Pharmaceuticals USA or their local FDA office for further instructions on how to return or dispose of the recalled medication.

The recalled product

Product
METOCLOPRAMIDE (METOCLOPRAMIDE)
Brand
METOCLOPRAMIDE
Manufacturer
Teva Pharmaceuticals USA
Category
Drug — Injectable
Hazard
Affected units
29,357

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 (7)

  • Lot # 31325042B
  • exp. date 06/2021 31325336B
  • exp. date 07/2021 31326042B
  • exp. date 10/2021 31326137B
  • exp. date 11/2021 31326230B
  • exp. date 12/2021 31323816B
  • exp. date 02/2021

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 15 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 15 products in this recall →

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Same brand · METOCLOPRAMIDE

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Same hazard · sterility

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