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
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II due to CGMP deviations. Per the rubric, risk-of-harm products where injury has not yet been reported are rated High (3).
Plain-English summary
Baxter Healthcare Corporation is voluntarily recalling Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container. The recall is limited to Lot # NC194068 with an expiration date of 10/29/2027. The product is a prescription-only, sterile, nonpyrogenic intravenous medication manufactured by Baxter Healthcare Corporation in Deerfield, Illinois.
The recall was initiated by the firm on August 6, 2026, due to Current Good Manufacturing Practice (CGMP) deviations. The FDA has classified this recall as Class II, indicating a situation in which use of, or exposure to, the 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 nationwide in the United States, as well as in Puerto Rico and Chile. Healthcare providers and patients should check their inventory and records for the specific lot number and expiration date listed above. If the product is found, it should be quarantined and not administered until further notice.
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 (2)
- Lot # NC194068
- Exp Date: 10/29/2027.
Distribution
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