CLASS III Drug recall · Reported 14 Jan 2015 · FDA Enforcement Report
Triamcinolone Acetonide Lotion USP, 0.025% is supplied recalled by Akorn
Akorn is recalling Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: (, distributed nationwide in the US. The recall was initiated on 9 Dec 2014 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-0333-2015
- FDA event ID
- 70041
- Recalling firm
- Akorn, Lake Forest, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 9 Dec 2014
- FDA classified
- 6 Jan 2015
- Reported
- 14 Jan 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 9 Dec 2014 | Recall initiated by company | |
| 6 Jan 2015 | Classified by FDA | +28 days |
| 14 Jan 2015 | 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: The known impurity went out of specification at 12 months stability point.
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
Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.
Which lots are affected?
Lots 1413900, 1417200, 1417300, Exp. 02/15
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 26 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 Akorn
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|---|---|---|---|---|---|
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
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| Drug | CLASS II | Midazolam Injection, USP, 50 mg/ (5mg/mL) recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Lidocaine Ointment USP, 5%, 1 tubes recalled by Akorn | Akorn | Potency & Assay | Nationwide |
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Other Triamcinolone Acetonide recalls
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Triamcinolone Acetonide Cream recalled by Padagis US | Padagis US | Potency & Assay | Nationwide |
| Drug | CLASS II | Zilretta (triamcinolone acetonide extended-release recalledZilretta | Pacira Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Drug Vial Label: Zilretta¿ recalled by Pacira PharmaceuticalsZilretta | Pacira Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Triamcinolone Acetonide Injectable Suspension recalled by Eugia USTriamcinolone Acetonide | Eugia US | Particulate Matter | Nationwide |
| Drug | CLASS II | Triamcinolone Acetonide cream, 0.1% tube recalled by Direct RxTriamcinolone Acetonide | Direct Rx | Manufacturing (CGMP) Deviations | GA, ID |