Pharmakon Recalls Epinephrine Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling Epinephrine HCI syringes because the company cannot ensure the products are 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 assurance of sterility in a compounded drug, which poses a significant risk of infection or serious injury.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling Epinephrine HCI 5 mcg/mL in 0.9% Sodium Chloride, 10mL syringes. The recall is being conducted because the company lacks assurance of the sterility of the affected products.
The recall covers 1,200 units of the compounded prescription medication. The products were distributed nationwide, with specific distribution to VA/DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. The recall includes all sterile compounded products within their expiry dates.
Healthcare providers and patients should stop using the recalled Epinephrine HCI syringes and contact Pharmakon Pharmaceuticals for further instructions or a replacement.
The recalled product
- Product
- Epinephrine HCI 5 mcg/mL in 0.9% Sodium Chloride, 10mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0800-72
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Category
- Drug — Compounded Injectable
- Affected units
- 1,200
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
- HighPharmakon Recalls Subpotent Epinephrine Injectable Syringes Nationwide
FDA (Drugs) · 2016-02-03
- ModeratePharmakon Recalls Ephedrine Sulfate Syringes Due to Stability Data Issues
FDA (Drugs) · 2016-02-03
- ModeratePharmakon Recalls Phenylephrine Syringes Due to Stability Data Issues
FDA (Drugs) · 2016-02-03
- CriticalPharmakon Recalls Morphine Sulfate Syringes Due to High Potency
FDA (Drugs) · 2016-06-01
- HighEpinephrine Injection Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2022-07-27
- SevereSCA Pharmaceuticals Recalls Phenylephrine Syringes Due to Sterility Concerns
FDA (Drugs) · 2021-01-13