FDA Recalls Oxytocin IV Bags Due to Sterility Assurance Deficiency
Central Admixture Pharmacy Services is recalling oxytocin IV bags nationwide due to insufficient validation of sterilization decontamination processes. The recall affects 6,037 bags distributed across multiple lots.
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 with a serious theoretical hazard—lack of sterility assurance due to insufficient decontamination validation. No illnesses or injuries have been reported. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, placing it at High severity.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling oxytocin 20 units in 0.9% sodium chloride solution, supplied in 1,000 mL IV bags. The recall affects 6,037 bags distributed nationwide.
The FDA found that the manufacturer lacks adequate validation data for decontamination cycles used in the production process. This deficiency creates insufficient assurance that the bags meet sterility standards required for injectable medications.
Healthcare facilities and pharmacies that received affected lots should stop using the product immediately and contact the manufacturer for return instructions. Affected lot numbers include 36-239496 through 36-254396, with expiration dates ranging from July 12, 2023, to September 4, 2023. If any of this product has been administered to patients, healthcare providers should follow FDA guidance regarding patient follow-up and notification.
The recalled product
- Product
- oxyTOCIN 20 units added to 0.9% sodium chloride 1,000 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6043-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Hazard
- lack-of-sterility
- 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: 36-239496
- Exp. 7/12/2023
- 36-240256
- Exp. 7/17/2023
- 36-241134
- Exp. 7/19/2023
- 36-241928
- Exp. 7/23/2023
- 36-243835
- Exp. 7/31/2023
- 36-245010
- 36-245011
- Exp. 8/1/2023
- 36-245529
- 36-245532
- Exp. 8/2/2023
- 36-246255
- 36-246256
- 36-246258
- 36-246259
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
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27