Wells Pharmacy Recalls Dexamethasone Sodium Phosphate Injectable Vials
Wells Pharmacy Network LLC is recalling 16 vials of Dexamethasone Sodium Phosphate 24 mg/mL injectable 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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or in this case, a sterility issue which is a significant safety concern, are rated as Severe (4).
Plain-English summary
Wells Pharmacy Network LLC is recalling 16 vials of Dexamethasone Sodium Phosphate 24 mg/mL (2.4%), Injectable, 2 mL vial. The product was compounded by Wells Pharmacy in Ocala, FL. The recall is being conducted due to a lack of assurance of sterility.
The affected product includes all lot codes prepared between 02/22/2016 and 09/14/2016, within expiry. One known lot code is 08082016@45. The product was distributed nationwide.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for instructions on disposal or replacement.
The recalled product
- Product
- Dexamethasone Sodium Phosphate 24 mg/mL (2.4%), Injectable, 2 mL vial, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Injectable Sterile
- Hazard
- Affected units
- 16
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 (2)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known lot code: 08082016@45.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 97 recalled by Wells Pharmacy Network LLC 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 97 products in this recall →Related recalls
Same manufacturer · Wells Pharmacy Network LLC
See all →- SevereWells Pharmacy Recalls Injectable Compounds Due to Sterility Concerns
FDA (Drugs) · 2017-01-11
- SevereWells Pharmacy Recalls Compounded Chorionic Gonadotropin Injectable Kits
FDA (Drugs) · 2017-01-11
- SevereWells Pharmacy Recalls Compounded Injectable Due to Sterility Concerns
FDA (Drugs) · 2017-01-11
- SevereWells Pharmacy Recalls Trimix with Atropine Injectable Due to Sterility Concerns
FDA (Drugs) · 2017-01-11
- SevereWells Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns
FDA (Drugs) · 2017-01-11
Same hazard · sterility
See all →- SevereK.C. Pharmaceuticals Recalls Target Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- SevereFDA Recalls Dexamethasone Injectable Vials Due to Sterility Concerns
FDA (Drugs) · 2014-11-12
- SevereGreen Valley Drugs Recalls Dexamethasone Sodium Phosphate Injection Due to Sterility Concerns
FDA (Drugs) · 2013-05-22
- ModerateWise Pharmacy Recalls Dexamethasone Sodium Phosphate Injection Due to Processing Controls
FDA (Drugs) · 2019-08-07
- LowWest-Ward Recalls Dexamethasone Sodium Phosphate Injection Due to Impurity
FDA (Drugs) · 2017-11-29
- LowWest-Ward Recalls Dexamethasone Sodium Phosphate Injection Due to Impurities
FDA (Drugs) · 2017-11-29
- SevereUS Compounding Recalls Dexamethasone Sodium Phosphate Vials Due to Sterility Concerns
FDA (Drugs) · 2015-11-25