Class II · Moderate risk
oxyTOCIN 10 units added to Lactated Ringer's 500 mL per bag
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Is Oxytocin recalled?
Yes — there is an active recall. 3 ongoing FDA recalls mention Oxytocin (76 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Oxytocin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Oxytocin recalls on record
none so far in 2026; 76 on record, newest first
Class II · Moderate risk
oxyTOCIN 30 units added to dextrose 5%/Lactated Ringer's 500 mL per bag
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
oxyTOCIN 20 units added to dextrose 5%/Lactated Ringer's 1
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class III · Low risk
Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL
Subpotent Drug: Out of specification results for low potency was obtained.
Class III · Low risk
oxyTOCIN 30 Units/500 mL
Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).
Class II · Moderate risk
Oxytocin 30 Units/500 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Oxytocin 30 Units/500 mL
Lack of Assurance of Sterility
Class II · Moderate risk
oxyTOCIN 30 Units/500 mL
Subpotent drug - Product did not contain drug.
Class II · Moderate risk
OxyTOCIN in 0.9% Sodium Chloride Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Oxytocin 60 units/1000 mL Lactated Ringers Intravenous Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Oxytocin 30 units in NS 500 mL bag
Lack of sterility assurance.
Class III · Low risk
Oxytocin 30 Units added to NS 500 mL
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class III · Low risk
Oxytocin 20 Units added to NS 1000 mL
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class III · Low risk
Oxytocin 10 Units added to NS 1000 mL
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class II · Moderate risk
Oxytocin 30 unit in LR 500 mL 0.06 units/mL IV
Lack of Assurance of Sterility
Class II · Moderate risk
Oxytocin USP
Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Class II · Moderate risk
15 units Oxytocin added to 0.9% Sodium Chloride Injection
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
Class II · Moderate risk
Oxytocin 30 Units in 0.9% Sodium Chloride Solution
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag
Lack Of Assurance Of Sterility.
Class II · Moderate risk
OXYtocin 30 units added to 0.9% Sodium Chloride 500 mL bag
Lack of Assurance of Sterility.
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
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