Norepinephrine injectable medication recalled nationwide for sterility assurance
SterRx recalled 125,598 bags of norepinephrine injectable medication nationwide because the manufacturer could not guarantee the product's sterility. The recalled medication has expiration dates from July 2023 to April 2024.
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 an injectable medication where sterility cannot be assured. The hazard is a manufacturing control issue with potential for product contamination, but no illnesses or injuries have been reported. The score reflects a risk-of-harm product without confirmed harm.
Plain-English summary
SterRx, LLC has recalled 125,598 bags of norepinephrine injectable medication distributed nationwide. The product contains norepinephrine 8 mg per 250 mL in 0.9% sodium chloride solution, supplied in 250 mL single-dose bags. The medication is prescription-only.
The recall is due to lack of assurance of sterility. Norepinephrine is an injectable medication that must meet strict sterility requirements. The manufacturer was unable to provide adequate assurance that all affected lots met those required sterility standards.
The affected lots include multiple lot numbers with expiration dates from July 2023 through April 2024, identified by FDA recall number D-0932-2023. The affected lot numbers are: 490071, 490089, 490118, 490126, 490169, 491276, 491284, 491612, 497467, 497475, 499104, 499112, 499121, 499278, 499358, 502019, 502027, 502035, 503513, and 504217.
Anyone with affected inventory should stop using the recalled medication immediately and contact SterRx, LLC at 141 Idaho Avenue, Plattsburgh, NY 12903, or their pharmaceutical supplier, for guidance on return or disposal.
The recalled product
- Product
- Norepinephrine 8 mg per 250 mL (32 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 70324-577-01.
- Manufacturer
- SterRx, LLC
- Category
- Drug — Injectable / Intravenous
- Hazard
- 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 (20)
- Lot #: 490071
- Exp 30-Jul-23
- 490089
- Exp 4-Aug-23
- 490118
- 490126
- Exp 5-Aug-23
- 490169
- Exp 10-Aug-23
- 491276
- Exp 11-Aug-23
- 491284
- Exp 12-Aug-23
- 491612
- Exp 18-Aug-23
- 497467
- Exp 8-Dec-23
- 497475
- Exp 9-Dec-23
- 499104
Distribution
Distributed nationwide across the United States.
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