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 FDA classified this as a Class II recall involving a prescription drug due to CGMP deviations, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corporation is voluntarily recalling specific lots of Clindamycin Injection USP in 5% Dextrose. The affected product is a prescription-only, sterile, nonpyrogenic intravenous solution packaged in 50 mL single-dose containers. The recall was initiated on August 6, 2026, and is currently ongoing.
The recall was triggered by Current Good Manufacturing Practice (CGMP) deviations. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The affected lots are NC185424 (expiring 2/12/2027), NC185479 (expiring 2/13/2027), and NC193948 (expiring 10/23/2027).
The product was distributed nationwide in the United States, as well as in Puerto Rico and Chile. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected product. Patients who have received the medication should contact their healthcare provider for guidance.
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 (6)
- Lot # NC185424
- Exp Date: 2/12/2027
- Lot # NC185479
- Exp Date: 2/13/2027
- Lot # NC193948
- Exp Date: 10/23/2027.
Distribution
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