Qualitest Recalls Dexamethasone Elixir Due to Failed Impurity Specifications
Vintage Pharmaceuticals is recalling 2,568 bottles of Dexamethasone Elixir because the product failed impurity and degradation specifications.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.
Plain-English summary
Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals is recalling 2,568 bottles of Dexamethasone Elixir, USP, 0.5 mg/5 mL, 8 fl.oz. The product is prescription-only and was distributed nationwide. The specific lot number is 0000007104 with an expiration date of 05/17.
The recall was initiated because the product failed impurity and degradation specifications. This indicates that the medication may not meet the required quality standards for safety and purity.
Consumers and healthcare providers should check their inventory for this specific lot and expiration date. If found, the product should be returned to the pharmacy or supplier for disposal or replacement.
The recalled product
- Product
- DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC 0603-1147-56
- Category
- Drug — Prescription Liquid
- Hazard
- Affected units
- 2,568
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)
- Lot # 0000007104
- Exp 05/17
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals
See all →- LowQualitest Recalls Hydrocortisone Lotion for Excessive Potency
FDA (Drugs) · 2017-05-31
- LowQualitest Recalls Temazepam Capsules Due to Failed Stability Specifications
FDA (Drugs) · 2017-01-11
- ModerateQualitest Recalls Hydrochlorothiazide Capsules Due to Particulate Matter
FDA (Drugs) · 2015-11-25
- LowQualitest Recalls Ranitidine Syrup Due to Preservative Stability Failure
FDA (Drugs) · 2015-11-11
- ModerateQualitest Recalls Lisinopril Tablets for Failed Dissolution Specifications
FDA (Drugs) · 2015-09-09
Same hazard · impurity
See all →- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17