Agency classClass IIOur severity:Severe FDA (Drugs)·D-0807-2026·Announced 2026-09-09

Baxter Recalls Daptomycin Injection Due to Manufacturing Deviations

Baxter Healthcare is voluntarily recalling Daptomycin in Sodium Chloride Injection due to Current Good Manufacturing Practice (CGMP) deviations.

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: The source text explicitly identifies the recall as FDA Class II. Per the severity rubric, FDA Class II recalls are classified as Severe (Score 4), as they may cause temporary or medically reversible adverse health consequences.

Plain-English summary

Baxter Healthcare Corporation is voluntarily recalling Daptomycin in 0.9% Sodium Chloride Injection, 500 mg per 50 mL, NDC 0338-0714-24. The recall is initiated due to Current Good Manufacturing Practice (CGMP) deviations.

The affected product is identified by Lot # NC188692 with an expiration date of 11/22/2027. The product was distributed nationwide in the United States, as well as in Puerto Rico and Chile.

This is an FDA Class II recall, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The recall status is ongoing.

The recalled product

Product: Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 500 mg total, in 50 mL Single Dose Container (24 bags/carton), Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0714-24.
Manufacturer: Baxter Healthcare Corporation
Category: Drug — Antibiotic Injection
Hazard: cgmp-deviation

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 (2)

Lot # NC188692
Exp Date: 11/22/2027.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Baxter Healthcare Corporation

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