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.
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: 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
- Hazard
- manufacturing-defect
- sterility-defect
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.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- ModerateGas-X Simethicone 125 mg softgels recall for incomplete labeling
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27