FDA Recalls Fentanyl Injection Due to Sterility Assurance Concerns
RXQ Compounding LLC is recalling fentanyl injection syringes because the agency could not ensure the product was sterile.
What this means for you
Illness, injury, or structural failure has been reported. 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 sterility assurance for an injectable drug, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for fentaNYL 0.05MG/ML INJ SOL (PF), 55ML per syringe, manufactured by RXQ Compounding LLC. The recall was initiated due to a lack of assurance of sterility for the product.
The affected product is identified by NDC 70731-0118-55 and includes all lots within their expiration dates. The recall covers distribution across the United States. The FDA classifies this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the recalled fentanyl injection and contact their healthcare provider or pharmacist for guidance on alternative treatments or replacement products.
The recalled product
- Product
- fentaNYL 0.05MG/ML INJ SOL (PF), 55ML per syringe (C-II) RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0118-55
- Manufacturer
- RXQ Compounding LLC
- Category
- Drug — Injectable
- Hazard
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 lots within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 86 recalled by RXQ Compounding LLC 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.
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