Oxytocin Injectable Solution Recalled for Sterility Assurance Questions
Central Admixture Pharmacy Services is recalling oxytocin injectable solution after FDA inspection questioned sterility. Over 104,000 bags distributed nationwide are affected.
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 drug recall for a high-risk injectable product with lack of sterility assurance. No illnesses or injuries have been reported, making this a risk-of-harm product where injury has not yet occurred, which per the rubric is rated High (3).
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling oxytocin 30 units added to 0.9% sodium chloride 500 mL per bag. This is a prescription-only injectable medication. The recall affects approximately 104,807 bags with multiple lot numbers and expiration dates ranging from April to June 2023.
The recall was initiated after an FDA inspection raised questions about whether these products maintain the required sterility assurance. For injectable medications, lack of sterility assurance poses a risk of infection to patients who receive the medication.
The recalled product was distributed nationwide to healthcare facilities and pharmacies. Healthcare providers should immediately quarantine affected lots and contact their suppliers about replacement products. Patients or providers who have received this medication should not use it and should consult with healthcare providers about appropriate follow-up.
The recalled product
- Product
- oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6044-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable / Prescription
- Hazard
- sterility-failure
- infection-risk
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 # 37-883041
- 37-883043
- 37-883044
- 37-883045
- 37-883047
- 37-883059
- 37-883060
- 37-883067
- 37-883071
- 37-883072
- 37-883131
- 37-883185
- Exp 04/28/2023
- 37-883492
- 37-883499
- 37-883501
- 37-883503
- 37-883514
- 37-883525
- 37-883526
Distribution
Distributed nationwide across the United States.
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