CLASS III Drug recall · Reported 2 Sep 2015 · FDA Enforcement Report
Topicort (desoximetasone) Topical Spray recalled by Taro Pharmaceuticals
Taro Pharmaceuticals is recalling Topicort (desoximetasone) Topical Spray, 25%, distributed nationwide in the US. The recall was initiated on 5 Aug 2015 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-1370-2015
- FDA event ID
- 71845
- Recalling firm
- Taro Pharmaceuticals, Brampton, N/A
- Brand
- Topicort
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Aug 2015
- FDA classified
- 25 Aug 2015
- Reported
- 2 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 5 Aug 2015 | Recall initiated by company | |
| 25 Aug 2015 | Classified by FDA | +20 days |
| 2 Sep 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: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.
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
Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles, Rx Only. Mfd by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada, L6T 1C1, Dist by: TaroPharma, Hawthorne, NY 10532. NDC: 51672-5281-7.
Where it was distributed
U.S. Nationwide
Questions about this recall
Is Topicort (desoximetasone) Topical Spray, 25% recalled?
Yes. Taro Pharmaceuticals recalled Topicort (desoximetasone) Topical Spray, 25% on 5 Aug 2015. The recall is Class III and its status is Terminated. Recall number D-1370-2015.
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.
Which lots are affected?
Lot #: C4177-14965, Expiry: February 2016; Lot #: C4178-14965, Expiry: February 2016.
Where was it sold?
U.S. 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 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 II | Desoximetasone Cream recalled by Taro PharmaceuticalsDesoximetasone | Taro Pharmaceuticals | Potency & Assay | PR |
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 |