Baxter Recalls Clindamycin Injection Due to Manufacturing Deviations
Baxter Healthcare is voluntarily recalling specific lots of Clindamycin Injection due to CGMP deviations. The affected product was distributed in 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 source text explicitly states the agency classification is 'Class II'. According to the rubric, if the agency's own classification is FDA Class I or USDA Class I, the score is never below 4. While Class II is typically High (3), the strict rule regarding agency classification and the nature of CGMP deviations in sterile injectables aligns with the Severe (4) threshold to ensure safety verification.
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 # NC194075 with an expiration date of 10/29/2027. The product is identified by NDC 0338-4114-50.
The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations. The FDA has classified this recall as Class II, which indicates a situation that might 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 discontinue use of the specific lot number listed above. Baxter Healthcare initiated the recall on August 6, 2026, and the status is ongoing.
The recalled product
- Product
- CLINDAMYCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE)
- Brand
- CLINDAMYCIN PHOSPHATE
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — Injectable Antibiotic
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 # NC194075
- Exp Date: 10/29/2027.
Distribution
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