Pharmakon Recalls Fentanyl Citrate Injection Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 75 bags of Fentanyl Citrate injection due to a lack of assurance of sterility. The product was distributed nationwide and to specific VA/DOD facilities.
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 assurance of sterility in an injectable drug, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 75 units of Fentanyl Citrate 10 mcg/mL in 0.9% Sodium Chloride 100 mL fill bags. The recall is being conducted because of a lack of assurance of sterility for the compounded sterile products. The affected product is identified by NDC 45183-0869-48 and includes all sterile compounded products within their expiry dates.
The recalled product was distributed nationwide as well as to specific VA/DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should discontinue use of the affected Fentanyl Citrate injection bags and contact Pharmakon Pharmaceuticals for further instructions or returns. Consumers should not use the product if they have received it and should consult their healthcare provider for alternative treatment options.
The recalled product
- Product
- Fentanyl Citrate 10 mcg/mL(PF) in 0.9% Sodium Chloride 100 mL fill bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0869-48
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Category
- Drug — Injectable
- Affected units
- 75
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 Sterile Compounded Products within Expiry
Distribution
Part of a larger recall action
This product is one of 88 recalled by Pharmakon Pharmaceuticals, Inc. 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 88 products in this recall →Related recalls
Same manufacturer · Pharmakon Pharmaceuticals, Inc.
See all →- SeverePharmakon Recalls Fentanyl and Ropivacaine Bags Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- SeverePharmakon Recalls Phenylephrine Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- SeverePharmakon Recalls Methohexital Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- SeverePharmakon Recalls Fentanyl Citrate Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- SeverePharmakon Recalls Ketamine Bags Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
Same hazard · sterility
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29