Pharmakon Recalls Fentanyl Citrate Cadd Cassettes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling Fentanyl Citrate 10mcg/mL cadd cassettes due to a lack of assurance of sterility. The affected products were 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. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in a potent opioid) fall under the 'Severe' category, and the rule states that FDA Class I or II classifications with significant risk factors should not be scored below 4 if injury/hospitalization is a plausible outcome of the defect.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling Fentanyl Citrate 10mcg/mL in 0.9% Sodium Chloride, 50mL Cadd Cassettes (grey). The recall is being conducted due to a lack of assurance of sterility. The affected products are prescription-only and were compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana.
The recall covers all sterile compounded products within their expiry date. The distribution pattern includes nationwide distribution as well as specific VA/DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia.
Consumers and healthcare providers should stop using the affected products and contact Pharmakon Pharmaceuticals or their healthcare provider for further instructions. 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.
The recalled product
- Product
- Fentanyl Citrate 10mcg/mL in 0.9% Sodium Chloride, 50mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0505-41
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Affected units
- 5
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 failure
See all →- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22