Agency classClass IIOur severity:Severe FDA (Drugs)·D-0821-2026·Announced 2026-09-09

Baxter Recalls Daptomycin Injection Due to Manufacturing Deviations

Baxter Healthcare is voluntarily recalling specific lots of Daptomycin Injection due to Current Good Manufacturing Practice (CGMP) deviations. The recall covers the US, Puerto Rico, and Chile.

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 FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe), as the agency's own classification mandates a minimum score of 4.

Plain-English summary

Baxter Healthcare Corporation is voluntarily recalling Daptomycin in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1,000 mL Single Dose Container. The recall is limited to Lot # NC193856 with an expiration date of 04/18/2028. The product is identified by NDC 0338-0718-12.

The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations. The FDA has classified this recall as Class II, which indicates 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.

The affected product was distributed in the United States, Puerto Rico, and Chile. Baxter Healthcare initiated the recall on August 6, 2026, and the status is ongoing. The company notified initial customers via letter.

The recalled product

Product: Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0718-12.
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 # NC193856
Exp Date: 04/18/2028.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Baxter Healthcare Corporation

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