Oxytocin injection recalled for incorrect sodium chloride concentration
QuVa Pharma is recalling oxytocin injections due to incorrect formulation. Bags contain 0.45% sodium chloride instead of the intended 0.9%.
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 III recall involving an incorrect formulation of a high-alert compounded medication (oxytocin). The formulation error creates direct risk of patient harm through delivery of an incorrect saline concentration. No illnesses or injuries have been reported. Per the rubric, this constitutes a risk-of-harm product where injury has not yet been reported, warranting a High severity score.
Plain-English summary
QuVa Pharma is recalling oxytocin 30 Units/500 mL injection due to an incorrect product formulation. The sodium chloride concentration in the bags is 0.45% instead of the intended 0.9%.
The affected product is oxytocin 30 Units/500 mL (0.06 Units/mL) added to 0.45% sodium chloride, labeled for IV use. This is a compounded medication for institutional or office use only. The recall affects 1,994 bags distributed nationwide with Lot number 30027403 and Beyond Use Date of 11/14/2022.
Healthcare facilities and providers should not use product from the affected lot. Remaining product should be quarantined and returned to QuVa Pharma. Patients receiving this medication should contact their healthcare provider if they have questions about potential exposure.
The recalled product
- Product
- oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This is a Compounded Product for Institutional or Office Use Only, Not for Resale, QuVa PHARMA 519 Route 173, Bloomsbury, NJ 08804, Total volume: 500 mL bag, NDC: 70092-1068-
- Manufacturer
- QuVa Pharma, Inc.
- Category
- Drug — Compounded Injectable
- Hazard
- formulation-error
- concentration-error
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 30027403
- BUD 11/14/2022
Distribution
Distributed nationwide across the United States.
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