The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-1034-2018·Announced 2018-08-15

Baxter Recalls Levofloxacin Injection Due to High Potency Levels

Baxter Healthcare is recalling 191,256 bags of Levofloxacin Injection in 5% Dextrose due to high out-of-specification potency results.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this as a Class III recall, which is typically associated with minor labeling errors or low-risk contamination where adverse health consequences are unlikely. The hazard involves potency deviation rather than a high-risk pathogen or structural defect.

Plain-English summary

Baxter Healthcare Corporation is recalling 191,256 bags of Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 50 mL Single Use Container bags. The product is a prescription-only intravenous antibiotic manufactured for Claris Lifesciences Inc. and by Claris Injectables Ltd. The recall covers specific lots with expiration dates ranging from September 2018 to October 2019.

The recall was initiated because the product had high out-of-specification results for levofloxacin, resulting in an increased concentration of the solution. This condition is classified as a superpotent drug issue. The affected product was distributed nationwide in the United States and Puerto Rico.

Healthcare providers and patients should stop using the recalled product and contact Baxter Healthcare or their supplier for instructions on return or replacement. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

The recalled product

Product
LEVOFLOXACIN (LEVOFLOXACIN)
Brand
LEVOFLOXACIN
Manufacturer
Baxter Healthcare Corporation
Category
Drug — Antibiotic
Hazard
Affected units
191,256

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 (9)

  • Lot #: A061178
  • A061183
  • A061236
  • Exp 09/18
  • A0A0937
  • Exp 08/19
  • A0A1044
  • A0A1048
  • Exp 10/19

UPCs (3)

  • 0336000047241
  • 0336000045018
  • 0336000046244

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 3 recalled by Baxter Healthcare Corporation 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 3 products in this recall →

Related recalls

Same brand · LEVOFLOXACIN

Same manufacturer · Baxter Healthcare Corporation

See all →

Same hazard · potency deviation

See all →

Similar recalls