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.
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 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
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
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