Fresenius Kabi epinephrine injection vials failed impurities and degradation specifications
Epinephrine Injection, USP, 1 mg/mL single-dose vials from Fresenius Kabi are being recalled because they failed impurities and degradation specifications. 898,050 vials affected.
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 graded this Class III, which the rubric places in the 1-2 band, and the source describes a specification failure without any stated health consequence.
Plain-English summary
Epinephrine Injection, USP, 1 mg/mL, 1 mL single-dose vial, prescription only, from Fresenius Kabi USA, LLC of Lake Zurich, Illinois, NDC 63323-696-02 for the vial and 63323-696-25 for the carton, is being recalled. The action covers 898,050 vials.
The stated reason is that the product failed impurities and degradations specifications. The FDA classified the action as Class III, its least serious classification, which is applied where use of the product is not likely to cause adverse health consequences.
Affected batches are 6133313 and 6133314 (expiring 06/2026), 6133315 (07/2026), 6133682 (09/2026), and 6134812 and 6134813 (04/2027). Distribution was USA nationwide. The vials are supplied to healthcare providers rather than sold directly to consumers.
Facilities should identify affected stock using the NDC and batch numbers above and follow the instructions issued by Fresenius Kabi.
The recalled product
- Product
- EPINEPHRINE (EPINEPHRINE)
- Brand
- EPINEPHRINE
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injectable
- Affected units
- 898,050
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 (10)
- Batch # 6133313
- 6133314
- Exp Date: 06/2026
- Batch # 6133315
- Exp Date: 07/2026
- Batch # 6133682
- Exp Date: 09/2026
- Batch # 6134812
- 6134813
- Exp Date: 04/2027.
UPCs (1)
- 0363323696023
Distribution
Distributed nationwide across the United States.
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