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.
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 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 →- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- SevereSterling Recalls Carboxymethylcellulose Sodium Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereSterling Pharmaceutical Recalls Lubricating Tears Due to Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereWalgreens Lubricant Eye Drops Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2026-09-30
- SevereSodium Chloride Ophthalmic Solution Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
Similar recalls
- SeverePharMEDium Recalls Fentanyl Citrate Infusions Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SevereSCA Pharmaceuticals Recalls Fentanyl Citrate Injection Bags Due to Sterility Concerns
FDA (Drugs) · 2017-08-02
- HighFentanyl Citrate Injection Recall Due to Lack of Sterility Assurance
FDA (Drugs) · 2022-07-27
- HighFDA Recalls Compounded Fentanyl Citrate IV Bags Due to Sterility Concerns
FDA (Drugs) · 2025-02-26
- HighFentanyl Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2022-06-08
- SevereSCA Pharmaceuticals Recalls Fentanyl Injectable Bags Due to Sterility Concerns
FDA (Drugs) · 2017-06-07