CLASS III Drug recall · Reported 1 Feb 2017 · FDA Enforcement Report
Dexamethasone Elixir, USP, 5 mg recalled by Vintage Pharmaceuticals
Vintage Pharmaceuticals is recalling Dexamethasone Elixir, USP, 5 mg, distributed nationwide in the US. The recall was initiated on 16 Jan 2017 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0438-2017
- FDA event ID
- 76272
- Recalling firm
- Vintage Pharmaceuticals, Huntsville, AL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 16 Jan 2017
- FDA classified
- 24 Jan 2017
- Reported
- 1 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 16 Jan 2017 | Recall initiated by company | |
| 24 Jan 2017 | Classified by FDA | +8 days |
| 1 Feb 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/ Degradation Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC 0603-1147-56
Where it was distributed
Nationwide
Questions about this recall
Is Dexamethasone Elixir, USP, 5 mg recalled?
Yes. Vintage Pharmaceuticals recalled Dexamethasone Elixir, USP, 5 mg on 16 Jan 2017. The recall is Class III and its status is Terminated. Recall number D-0438-2017.
Why was it recalled?
Failed Impurities/ Degradation Specifications
Which lots are affected?
Lot # 0000007104; Exp 05/17
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Vintage Pharmaceuticals
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lisinopril Tablets, USP, 40 mg, a) bottle recalled | Vintage Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg recalled | Vintage Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg recalled | Vintage Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Perphenazine Tablets recalled by Vintage Pharmaceuticals | Vintage Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Hydroxyzine Hydrochloride Oral Solution, USP, 10 mg/, 1 Pint recalled | Vintage Pharmaceuticals | Potency & Assay | Nationwide |