Phenylephrine Injection Recalled Due to Manufacturing Quality Violations
Fresenius Kabi Compounding recalled phenylephrine HCl injectable due to cGMP violations. The recall affects 2,756 doses distributed to 125 direct accounts nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II drug recall involving a sterile injectable with manufacturing quality violations. No illnesses or injuries reported, but this represents a risk-of-harm product where actual harm has not yet occurred, meeting the rubric criterion for High severity.
Plain-English summary
Fresenius Kabi Compounding, LLC, is recalling Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL in single-dose bags supplied as Fagron Sterile Services product. The recall affects 2,756 units with lot numbers C274-000037039 (expires 9-Oct-24) and C274-000037239 (expires 21-Oct-24), NDC 71506-010-58.
The product was recalled due to current Good Manufacturing Practice (cGMP) violations discovered during the manufacturing process. This is a voluntary recall initiated by the manufacturer and was classified as FDA Class II on October 21, 2024.
The affected product was distributed to 125 direct accounts nationwide. Healthcare facilities who received affected lots should discontinue use and contact Fresenius Kabi Compounding for instructions regarding return or disposal.
No illnesses or injuries have been reported in connection with this recall. The recall was terminated on August 15, 2025.
The recalled product
- Product
- Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58
- Manufacturer
- Fresenius Kabi Compounding, LLC
- Category
- Drug — Sterile Injectable
- Affected units
- 2,756
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 (3)
- Lot #C274-000037039
- exp. date 9-Oct-24 C274-000037239
- exp. date 21-Oct-24
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Fresenius Kabi Compounding, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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