CLASS II Drug recall · Reported 9 Nov 2016 · FDA Enforcement Report
Desoximetasone Cream recalled by Taro Pharmaceuticals
Taro Pharmaceuticals is recalling Desoximetasone Cream USP, 05%, distributed in Puerto Rico. The recall was initiated on 13 Sep 2016 and the FDA has classified it as Class II.
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-0117-2017
- FDA event ID
- 75349
- Recalling firm
- Taro Pharmaceuticals, Brampton
- Brand
- Desoximetasone
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Sep 2016
- FDA classified
- 1 Nov 2016
- Reported
- 9 Nov 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 13 Sep 2016 | Recall initiated by company | |
| 1 Nov 2016 | Classified by FDA | +49 days |
| 9 Nov 2016 | 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 Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
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
Desoximetasone Cream USP, 0.05% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1271-7
Where it was distributed
US & Puerto Rico
Questions about this recall
Is Desoximetasone Cream USP, 05% recalled?
Yes. Taro Pharmaceuticals recalled Desoximetasone Cream USP, 05% on 13 Sep 2016. The recall is Class II and its status is Terminated. Recall number D-0117-2017.
Why was it recalled?
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Which lots are affected?
Lot #: E0598-19624, E5099-19624, Exp. Jan 2017
Where was it sold?
US & Puerto Rico
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 Taro Pharmaceuticals
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP dropper recalledHydrocortisone And Acetic Acid | Taro Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Desoximetasone Cream recalled by Taro PharmaceuticalsDesoximetasone | Taro Pharmaceuticals | Potency & Assay | PR |
| Drug | CLASS III | Topicort (desoximetasone) Topical Spray recalled by Taro PharmaceuticalsTopicort | Taro Pharmaceuticals | Potency & Assay | Nationwide |
Other Desoximetasone recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Desoximetasone Ointment recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Desoximetasone Ointment recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Desoximetasone Ointment recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Desoximetasone USP (Micronized) for prescription compounding recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |
| Drug | CLASS III | Desoximetasone Ointment USP, 25% tubes recalled by Teligent | Teligent | Potency & Assay | TN |