Fagron norepinephrine injection recalled for sterility concerns and port defect
Fagron Compounding Services is recalling norepinephrine bitartrate injection due to two issues: the sterility of the product cannot be assured, and a blue plastic part on the administration port may detach during use. This medication is used in hospitals and medical facilities to treat critical conditions. Six specific lots distributed nationwide are affected.
From the FDA notice · Read the official notice ↗
What to do
- If you work in a hospital or medical facility, check if you have any of the affected lots (C274-000050004, C274-000050295, C274-000050773, C274-000051219, C274-000051318, or C274-000051602)
- Do not use any affected bags; remove them from stock immediately
- Contact Fagron Compounding Services or your supplier for instructions on return or disposal
- Notify your pharmacy or medical director if you have already used any affected doses
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5027-02
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 5 products — see all of them.
Details
- Units affected
- 5140 bags
- Illnesses reported
- None reported
- Manufactured in
- 8710 E 34th St N, Wichita, KS, United States
- Classification
- Class II
- Recall number
- D-0439-2026
In the FDA's words
- Description
- norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5027-02 Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port Lot: C274-000050004, Exp.: 4/24/2026; C274-000050295, Exp.:5/8/2026; C274-000050773, Exp.: 6/4/2026; C274-000051219, Exp.: 6/21/2026; C274-000051318, Exp.: 6/27/2026; C274-000051602, Exp.: 7/12/2026. Distribution: Nationwide in the U.S.A. Affected quantity: 5140 bags
- Hazard
- Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
5 products in this recall
Fagron IV norepinephrine and vancomycin bags recalled for sterility concerns
Fagron Compounding Services is recalling five premixed IV bags in 0.9% sodium chloride: norepinephrine bitartrate (16 mg and 32 mg per 250 mL) and vancomycin (1 g, 1.25 g and 1.5 g per 250 mL). The bags were made by Fagron Sterile Services in Wichita, Kansas, and sold nationwide, and the company cannot assure they are sterile. A blue break-off part on the administration port could also detach. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5026-02D-0438-2026 · 25,260 bags
- norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5027-02 (this page)D-0439-2026 · 5140 bags
- Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5083-01D-0440-2026 · 34,260 bags
- Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01D-0441-2026 · 16,130 bags
- Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5082-01D-0442-2026 · 11,680 bags