Norepinephrine Injectable Recalled Due to Lack of Sterility Assurance
SterRx recalled 2,088 bags of Norepinephrine 32 mg per 250 mL (Lot #490100) distributed nationwide due to lack of sterility assurance. The recall affects a critical care medication used in intensive care settings.
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 a sterile injectable product due to lack of sterility assurance. No illnesses or injuries have been reported in the source. The hazard is theoretical rather than confirmed contamination, but the product is a critical care medication where sterility failure poses significant risk of harm.
Plain-English summary
SterRx, LLC has recalled 2,088 bags of Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, Single Dose bags (Lot #490100, expiration date July 27, 2023). The product was distributed nationwide in the United States.
The recall was issued due to a lack of assurance of sterility. This means the manufacturer cannot guarantee that the product meets sterility standards. Norepinephrine is a critical care medication administered intravenously to support blood pressure in patients, typically in intensive care environments.
Healthcare facilities and providers should immediately stop using the affected product and verify their inventory for Lot #490100. Any units with this lot number should not be used.
For additional information, healthcare professionals should contact the FDA or SterRx, LLC directly.
The recalled product
- Product
- Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-702-01.
- Manufacturer
- SterRx, LLC
- Hazard
- lack-of-sterility
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 (2)
- Lot #: 490100
- Exp 27-Jul-23
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