Class II · Moderate risk
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
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Oxytocin 30 units in 0.9% Sodium Chloride 500 mL
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Class II · Moderate risk
Oxytocin all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Oxytocin 30 USP Units Added to 0.9% Sodium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Oxytocin 20 Units added to Lactated Ringers in a 1000 mL lntravia bag
Lack of Assurance of Sterility
Class II · Moderate risk
Oxytocin 30 Units added to Lactated Ringers in a 500 mL lntravia bag
Lack of Assurance of Sterility
Class II · Moderate risk
Oxytocin 10 Units added to Lactated Ringers in a 500 mL lntravia bag
Lack of Assurance of Sterility
Class II · Moderate risk
Oxytocin 20 Units added to 0.9% Sodium Chloride in a 1000mL lntravia bag
Lack of Assurance of Sterility
Class II · Moderate risk
Oxytocin 30 Units added to 0.9% Sodium Chloride in a 500 mL lntravia bag
Lack of Assurance of Sterility
Class II · Moderate risk
Oxytocin 100 units/ml Injection
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class I · High risk
oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Class II · Moderate risk
Oxytocin 30 Units in 500mL Sodium Chloride 0.9% Bags
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
Class II · Moderate risk
Oxytocin 10 Units/Ml
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Oxytocin Injection
Subpotent Drug; 15-month stability test station
Class II · Moderate risk
Oxytocin 20 units/ml Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class III · Low risk
Pitocin (Oxytocin Injection, USP)
Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C (68¿ to 77¿F)". Pitocin lot 225867 and part of Pitocin lot 231423 were labeled, "Store between 20¿ to 25¿C (28¿ to 77¿F)".
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