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.
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 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.
See all 86 products in this recall →Related recalls
Same manufacturer · RXQ Compounding LLC
See all →- HighRXQ Compounding Recalls Niacinamide Vials Due to Sterility Concerns
FDA (Drugs) · 2019-08-14
- SevereRXQ Compounding Recalls Glutathione Injection Due to Sterility Concerns
FDA (Drugs) · 2019-08-14
- SevereRXQ Compounding Recalls Methylcobalamin Injectable Solution Due to Sterility Concerns
FDA (Drugs) · 2019-08-14
- SevereRXQ Compounding Recalls Folic Acid Injection Due to Sterility Concerns
FDA (Drugs) · 2019-08-14
- SevereRXQ Compounding Recalls Midazolam Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-08-14
Same hazard · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- SevereUS Compounding Recalls Fentanyl Syringes Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-11-25
- SevereAssurance Infusion Recalls Fentanyl Injection Due to Sterility Concerns
FDA (Drugs) · 2020-01-22
- HighFDA Recalls Fentanyl Injectable Syringes Over Sterility Assurance Failure
FDA (Drugs) · 2023-10-11
- SevereAssurance Infusion Recalls Fentanyl Syringes Due to Sterility Concerns
FDA (Drugs) · 2020-01-22
- HighFDA Recalls Fentanyl Syringes Due to Sterility Validation Concerns
FDA (Drugs) · 2023-08-09
- HighFDA Recalls Fentanyl Injectable for Lack of Sterility Assurance
FDA (Drugs) · 2023-10-11