CLASS III Drug recall · Reported 23 Jul 2014 · FDA Enforcement Report
Triamcinolone Acetonide Lotion recalled by Fougera Pharmaceuticals
Fougera Pharmaceuticals is recalling Triamcinolone Acetonide Lotion USP, 1%, distributed nationwide in the US. The recall was initiated on 3 Jul 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-1440-2014
- FDA event ID
- 68683
- Recalling firm
- Fougera Pharmaceuticals, Melville, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 3 Jul 2014
- FDA classified
- 17 Jul 2014
- Reported
- 23 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Eye Drops
Timeline
| 3 Jul 2014 | Recall initiated by company | |
| 17 Jul 2014 | Classified by FDA | +14 days |
| 23 Jul 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Product as listed by the FDA
Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0337-60.
Where it was distributed
Nationwide
Questions about this recall
Is Triamcinolone Acetonide Lotion USP, 1% recalled?
Yes. Fougera Pharmaceuticals recalled Triamcinolone Acetonide Lotion USP, 1% on 3 Jul 2014. The recall is Class III and its status is Terminated. Recall number D-1440-2014.
Why was it recalled?
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Which lots are affected?
Lot(s): 497R, 498R, Exp 01/2015; 635R, 636R, Exp 03/2015; 850R, Exp 04/2015; 073S, Exp 05/2015; 074S, Exp 06/2015.
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 Fougera Pharmaceuticals
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|---|---|---|---|---|---|
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| Drug | CLASS II | Fluocinonide Gel recalled by Fougera Pharmaceuticals | Fougera Pharmaceuticals | Potency & Assay | Nationwide |
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| Drug | CLASS III | Triamcinolone Acetonide Cream recalled by Fougera PharmaceuticalsTriamcinolone Acetonide | Fougera Pharmaceuticals | Other | Nationwide |
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Other Triamcinolone acetonide recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Triamcinolone Acetonide Cream recalled by Padagis US | Padagis US | 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 USP, 1% tube recalled by Padagis USTriamcinolone Acetonide | Padagis US | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Triamcinolone Acetonide cream, USP, 1% tube recalledTriamcinolone Acetonide | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Triamcinolone Acetonide Lotion recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |