FDA recalls epinephrine injection for manufacturing compliance violations
Fresenius Kabi Compounding recalled epinephrine 0.9% sodium chloride injections due to current good manufacturing practice violations. The recall affecting 753 bags distributed to 125 healthcare accounts was terminated on August 15, 2025.
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: This is an FDA Class II recall for manufacturing compliance violations in an injectable drug product with no reported illnesses or injuries, qualifying as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Fresenius Kabi Compounding, LLC recalled EPINEPHrine 0.9% Sodium Chloride Injection USP (8 mg per 250 mL) due to current good manufacturing practice (cGMP) violations. The firm initiated the voluntary recall on September 25, 2024, and the recall was terminated on August 15, 2025.
The affected product included Lots C274-000038958 (expiration 17-Oct-24) and C274-000039206 (expiration 23-Oct-24), totaling 753 bags. The product was distributed to 125 direct accounts nationwide.
The FDA identified cGMP violations at the manufacturing facility. No illnesses or injuries were reported in connection with the recalled product. Patients who may have received this product should verify they do not possess affected lots and contact their healthcare provider if they have questions about their medication.
The recalled product
- Product
- EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58
- Manufacturer
- Fresenius Kabi Compounding, LLC
- Hazard
- Affected units
- 753
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 # C274-000038958
- exp. date 17-Oct-24 C274-000039206
- exp. date 23-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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