Zions RX Formulations Recalls Oxytocin Bags Due to Sterility Concerns
Zions RX Formulations is recalling 1,495 bags of Oxytocin 30 Units in 500mL Sodium Chloride 0.9% due to a lack of assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility in injectable products, which poses a significant risk of infection or serious injury.
Plain-English summary
Zions RX Formulations Services LLC is recalling 1,495 bags of Oxytocin 30 Units in 500mL Sodium Chloride 0.9% (Not for Dispensing, For Hospital Administration Only). The recall was initiated because the firm expanded its recall to other injectable products due to a lack of assurance of sterility resulting from poor aseptic practices observed at the facility.
The affected product is distributed in Arizona. Specific lot numbers and expiration dates are listed in the recall documentation, including lots expiring between December 2013 and January 2014. The product is intended for hospital administration only.
Healthcare facilities and consumers should stop using the affected product and contact the recalling firm for further instructions or a refund. This recall is classified as FDA Class II.
The recalled product
- Product
- Oxytocin 30 Units in 500mL Sodium Chloride 0.9% Bags, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
- Category
- Drug — Injectable
- Affected units
- 1,495
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 7 recalled by Zions RX Formulations Services LLC dba RX Formuations Serv. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · Zions RX Formulations Services LLC dba RX Formuations Serv.
See all →- SevereZions RX Formulations Recalls Magnesium Sulfate Bags Due to Sterility Concerns
FDA (Drugs) · 2014-04-16
- SevereZions RX Formulations Recalls Bupivacaine Due to Sterility Concerns
FDA (Drugs) · 2014-04-16
- SevereZions RX Formulations Recalls Potassium Phosphates Vials Due to Sterility Concerns
FDA (Drugs) · 2014-04-16
- SevereZions RX Formulations Recalls Vitamin B-12 Injections Due to Sterility Concerns
FDA (Drugs) · 2014-04-16
- CriticalZions RX Formulations Recalls Calcium Gluconate Injection Due to Contamination
FDA (Drugs) · 2014-04-16
Same hazard · sterility
See all →- SevereK.C. Pharmaceuticals Recalls Target Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- SevereBanner Pharmacy Recalls Oxytocin Infusion Bags Due to Sterility Concerns
FDA (Drugs) · 2017-11-01
- SeverePharmakon Recalls Oxytocin Infusion Bags Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- HighOxytocin Injectable Solution Recalled for Sterility Assurance Questions
FDA (Drugs) · 2023-05-31
- HighFDA Recalls Oxytocin Injectable Due to Sterility Assurance Failure
FDA (Drugs) · 2023-08-09
- HighFDA Recalls Oxytocin Injection Bags Over Sterility Assurance Failure
FDA (Drugs) · 2023-05-31
- HighFDA Recalls OxyTOCIN IV Bags Over Sterility Assurance Defect
FDA (Drugs) · 2023-08-09