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.
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 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 SODIUM CHLORIDE (DAPTOMYCIN IN SODIUM CHLORIDE)
- Brand
- DAPTOMYCIN IN SODIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — Antibiotic Injection
- Hazard
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
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