Norepinephrine Injectable Recalled Due to Sterility and Equipment Safety Concerns
Fagron Compounding Services is recalling 5,140 bags of norepinephrine injectable nationwide due to lack of sterility assurance and a potentially detachable component in the administration port. The affected lots expire between April and July 2026.
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: This is an FDA Class II recall of an injectable medication with two serious manufacturing defects: sterility assurance failure and equipment malfunction. However, no illnesses or injuries are reported in the source. Under the severity rubric, FDA Class II recalls without reported hospitalization or injury reports, but involving potential risk of harm, are classified as High (3).
Plain-English summary
Fagron Compounding Services is recalling norepinephrine bitartrate 32mg per 250mL in 0.9% sodium chloride injection USP. The recall affects 5,140 bags distributed nationwide in the United States.
The recall is due to two issues: (1) lack of assurance of sterility in the manufactured product, and (2) the potential for a blue break-off component to detach from the administration port. Norepinephrine is a critical injectable medication used in hospital and emergency settings to treat severe low blood pressure and shock.
The affected lot numbers are C274-000050004 (expiration 4/24/2026), C274-000050295 (5/8/2026), C274-000050773 (6/4/2026), C274-000051219 (6/21/2026), C274-000051318 (6/27/2026), and C274-000051602 (7/12/2026). Healthcare facilities and providers should contact the FDA or the manufacturer for instructions regarding the return or proper disposal of affected product.
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 — Injectable
- Hazard
- sterility-failure
- equipment-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 (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.
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
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27