Pharmakon Recalls Oxytocin Lactated Ringers Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 384 units of compounded Oxytocin in Lactated Ringers 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 the hazard involves a lack of assurance of sterility in a compounded drug, which poses a significant risk of infection or serious injury.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 384 units of Oxytocin 20 Units added to Lactated Ringers in a 1000 mL Intravia bag. The product is compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana, and is available by prescription only. The recall is being conducted due to a lack of assurance of sterility.
The affected product has the NDC 45183-0769-04. The recall covers all sterile compounded products within their expiry dates. The distribution pattern is nationwide, with specific distribution to VA/DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia.
Consumers and healthcare providers should stop using the affected product and contact Pharmakon Pharmaceuticals or their healthcare provider for further instructions.
The recalled product
- Product
- Oxytocin 20 Units added to Lactated Ringers in a 1000 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0769-04
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Category
- Drug — Compounded Sterile Drug
- Affected units
- 384
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 (1)
- All Sterile Compounded Products within Expiry
Distribution
Part of a larger recall action
This product is one of 88 recalled by Pharmakon Pharmaceuticals, Inc. 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 88 products in this recall →Related recalls
Same manufacturer · Pharmakon Pharmaceuticals, Inc.
See all →- SeverePharmakon Recalls Fentanyl and Ropivacaine Bags Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- SeverePharmakon Recalls Phenylephrine Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- SeverePharmakon Recalls Methohexital Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- SeverePharmakon Recalls Fentanyl Citrate Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- SeverePharmakon Recalls Ketamine Bags Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
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
- SevereSCA Pharmaceuticals Recalls Oxytocin Bags Due to Sterility Concerns
FDA (Drugs) · 2017-11-08
- HighFDA Recalls Oxytocin Injectable Bags Due to Sterility Assurance Failure
FDA (Drugs) · 2023-05-31
- HighOxytocin and Lactated Ringer's Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2023-05-31
- HighFDA Recalls Oxytocin IV Bags for Sterility Assurance Issues
FDA (Drugs) · 2023-08-09
- HighFDA recalls oxytocin-lactated ringer IV bags due to sterility concerns
FDA (Drugs) · 2023-08-09
- HighInjectable oxyTOCIN and Lactated Ringer's Recalled Over Sterility Concerns
FDA (Drugs) · 2023-05-31