New England Compounding Center Recalls Dexamethasone Sodium Phosphate Vials
New England Compounding Center is recalling Dexamethasone Sodium Phosphate vials due to a lack of assurance of sterility.
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 the hazard involves a lack of assurance of sterility in a drug product, which carries a risk of serious injury or death.
Plain-English summary
New England Compounding Center is recalling Dexamethasone Sodium Phosphate 4 mg/mL, 6 mg/mL, and 8 mg/mL vials. The recall is being conducted because of a lack of assurance of sterility.
The affected products were distributed nationwide. The recall includes all lot codes for these specific vials.
Consumers and healthcare providers should stop using the recalled vials and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufactured by New England Compounding Center, Framingham, MA
- Manufacturer
- New England Compounding Center
- Category
- Drug — Injectable Sterile Drug
- Hazard
- Affected units
- 20
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 lot codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by New England Compounding Center 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 17 products in this recall →Related recalls
Same manufacturer · New England Compounding Center
See all →- SevereNew England Compounding Center Recalls Lidocaine Vials Due to Sterility Concerns
FDA (Drugs) · 2013-01-09
- SevereNew England Compounding Center Recalls Isovue Vials Due to Sterility Concerns
FDA (Drugs) · 2013-01-09
- SevereNew England Compounding Center Recalls Lidocaine Dextrose Due to Sterility Concerns
FDA (Drugs) · 2013-01-09
- HighNew England Compounding Center Recalls Triamcinolone Vials Due to Sterility Concerns
FDA (Drugs) · 2013-01-09
- CriticalFDA Recalls Methylprednisolone Acetate Injection Due to Non-Sterility
FDA (Drugs) · 2013-01-09
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- 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
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- SevereUS Compounding Recalls Dexamethasone Sodium Phosphate Vials Due to Sterility Concerns
FDA (Drugs) · 2015-11-25
- SevereFDA Recalls Dexamethasone Injectable Vials Due to Sterility Concerns
FDA (Drugs) · 2014-11-12
- SevereDexamethasone Solution Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2014-01-22
- SevereUS Compounding Recalls Dex Combo Sterile Vials Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-11-25
- SeverePharmedium Recalls Dexamethasone Sodium Phosphate Due to Sterility Assurance Issues
FDA (Drugs) · 2018-02-28
- SevereDexamethasone Injectable Recalled for Sterility Concerns
FDA (Drugs) · 2013-06-12