Eagle Pharma Recalls Oxytocin Injection Due to Sterility Concerns
Eagle Pharma Outsourcing LLC is recalling specific lots of Oxytocin injection 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 due to a lack of assurance of sterility, which may cause temporary or medically reversible adverse health consequences. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Eagle Pharma Outsourcing LLC is recalling 500-mL single-use containers of Oxytocin, 30 USP Units, added to 0.9% Sodium Chloride. The recall involves Lot OXY30-1006 with an expiration date of 10/10/2026. The product was distributed nationwide within the U.S.
The recall was initiated because of a lack of assurance of sterility. This means the manufacturer cannot guarantee that the product is free from microorganisms, which poses a risk of infection if administered to patients.
Healthcare providers and patients should stop using the affected product immediately. Consumers should check their medication for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be returned to the pharmacy or healthcare provider for disposal or replacement.
The recalled product
- Product
- OXYTOCIN, 30 USP UNITS, Added to 0.9% Sodium Chloride 500 mL - Single-Use Container, Rx Only, EAGLE PHARMA OUTSOURCING, 2200 Riverchase Center, Suite 675, Hoover, AL 35244, UPC: 6985203050. NDC 69852-030-50
- Manufacturer
- Eagle Pharma Outsourcing LLC
- Category
- Drug — Injectable Medication
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 (2)
- Lot: OXY30-1006
- Expiry: 10/10/2026.
Distribution
Distributed nationwide across the United States.
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