Fagron norepinephrine 32 mg bags recalled over sterility and port part
Fagron is recalling norepinephrine bitartrate 32 mg in 250 mL sodium chloride bags for lack of assurance of sterility and because a blue break-off part could detach from the administration port.
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 recall of a sterile injectable where sterility cannot be assured and a port component may detach, a risk of harm with no injuries reported.
Plain-English summary
Fagron Sterile Services is recalling norepinephrine bitartrate, 32 mg per 250 mL of 0.9% Sodium Chloride Injection USP, NDC 71266-5027-02. The action covers 5,140 bags.
Two reasons are stated: lack of assurance of sterility, and that the blue break-off part could detach from the administration port. Sterility is a defining requirement of an injectable product, and a detaching component at the administration port affects the integrity of the delivery route. The FDA classified the action as Class II.
Affected lots include C274-000050004 (exp 4/24/2026), C274-000050295 (exp 5/8/2026), C274-000050773 (exp 6/4/2026), C274-000051219 (exp 6/21/2026) and C274-000051318 (exp 6/27/2026), with the full list in the recall notice. Distribution was nationwide in the USA.
This is a compounded prescription product supplied to healthcare facilities. Facilities should check stock against the lot numbers in the recall notice, quarantine affected bags and follow the instructions issued by Fagron.
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
- Manufacturer
- Fagron Compounding Services
- Category
- Drug — Compounded injectable
- Affected units
- 5,140
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 (12)
- 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
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Fagron Compounding Services 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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