Agency classClass IIOur severity:Severe FDA (Drugs)·D-0808-2026·Announced 2026-09-09

Baxter Recalls Clindamycin Injection Due to Manufacturing Deviations

Baxter Healthcare is voluntarily recalling specific lots of Clindamycin 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. According to the severity rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when no specific hospitalization reports are present to elevate it to Critical, but the classification itself mandates a minimum of 4.

Plain-English summary

Baxter Healthcare Corporation is voluntarily recalling Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Containers. The recall was initiated on August 6, 2026, due to Current Good Manufacturing Practice (CGMP) deviations.

The affected product is identified by NDC 0338-3612-50. The specific lots subject to the recall are Lot # NC193764 (Expiration Date: 10/18/2027) and Lot # NC195232 (Expiration Date: 11/25/2027). The product was distributed nationwide in the United States, as well as in Puerto Rico and Chile.

This is a Class II recall, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Healthcare providers and patients should discontinue use of the affected lots and contact Baxter Healthcare for further instructions.

The recalled product

Product: CLINDAMYCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE)
Brand: CLINDAMYCIN PHOSPHATE
Manufacturer: Baxter Healthcare Corporation
Category: Drug — Antibiotic Injection
Hazard: manufacturing-deviation
quality-control

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 (4)

Lot # NC193764
Exp Date: 10/18/2027
Lot # NC195232
Exp Date: 11/25/2027.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same brand · CLINDAMYCIN PHOSPHATE

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