Sterile drug injection bags recalled for manufacturing process violations
Fresenius Kabi Compounding recalled 1,631 bags of Phenylephrine HCl injection due to manufacturing process violations. The product was distributed to 125 healthcare facilities nationwide. The recall was concluded in August 2025.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II voluntary recall for current good manufacturing practice violations in a sterile injectable product with no reported illnesses or injuries. Manufacturing compliance-based recalls are classified as precautionary.
Plain-English summary
Fresenius Kabi Compounding recalled 1,631 bags of Phenylephrine HCl 0.9% Sodium Chloride Injection USP (20 mg per 250 mL) in single-dose bags. The affected lot number is C274-000037046, which expired on October 13, 2024.
The recall was initiated on September 25, 2024, due to violations of current good manufacturing practice (cGMP) in the manufacturing process.
The product had been distributed to 125 direct accounts nationwide. Healthcare facilities that received the product were directed to stop use of the affected lot and quarantine any remaining units.
This recall was voluntary, initiated by the manufacturer. The FDA terminated the recall on August 15, 2025.
The recalled product
- Product
- Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58
- Manufacturer
- Fresenius Kabi Compounding, LLC
- Hazard
- cgmp-violation
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 # C274-000037046
- exp. date 13-Oct-24
Distribution
Distributed nationwide across the United States.
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