FDA Recalls Oxytocin Injectable Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 3,821 bags of oxytocin IV bags nationwide due to lack of sterility assurance and missing validation data for decontamination cycles.
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 medication with documented sterility assurance failure and missing validation data. No illnesses or contamination incidents have been reported, placing this in the High category per the rubric as a risk-of-harm product without reported injury.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 3,821 bags of oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL intravenous bags. The U.S. Food and Drug Administration classified this as a Class II recall.
The reason for the recall is a lack of assurance of sterility and inadequate validation data for the decontamination cycles used in manufacturing. While no illnesses or contamination incidents have been reported to date, the sterility concern poses a potential risk to patients who receive this injectable medication.
The product was distributed nationwide throughout the United States. Affected lot numbers include those expiring from July 20, 2023 through September 5, 2023.
Healthcare providers, hospitals, and pharmacies should immediately stop using affected lots and follow recall instructions. Patients who may have received this medication should consult with their healthcare provider for guidance.
The recalled product
- Product
- oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6042-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable Medication
- Hazard
- sterility-failure
- contamination-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: 36-241662
- Exp. 7/20/2023
- 36-242725
- Exp. 7/26/2023
- 36-243607
- Exp. 7/30/2023
- 36-243837
- 36-243838
- Exp. 7/31/2023
- 36-245517
- 36-245523
- 36-245525
- 36-245662
- Exp. 8/2/2023
- 36-247254
- 36-247255
- Exp. 8/8/2023
- 36-247983
- Exp. 8/10/2023
- 36-254917
Distribution
Distributed nationwide across the United States.
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