CLASS III Drug recall · Reported 8 Jun 2016 · FDA Enforcement Report
¿Topicort (desoximetasone) Cream recalled by Taro Pharmaceuticals U.S.A
Taro Pharmaceuticals U is recalling ¿Topicort (desoximetasone) Cream USP, 0.05%, distributed in 9 states. The recall was initiated on 31 Mar 2016 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-0950-2016
- FDA event ID
- 73829
- Recalling firm
- Taro Pharmaceuticals U, Hawthorne, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 31 Mar 2016
- FDA classified
- 31 May 2016
- Reported
- 8 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 31 Mar 2016 | Recall initiated by company | |
| 31 May 2016 | Classified by FDA | +61 days |
| 8 Jun 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
Subpotent Drug
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) Cream USP, 0.05%, Packaged in 5 g Tubes, Professional Sample Only, Rx Only. Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: TaroPharma a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC: 51672-5205-5.
Where it was distributed
U.S. Including: CA, CT, MA, MD, NY, NJ, OK, TX, and WA
CaliforniaConnecticutMassachusettsMarylandNew JerseyNew YorkOklahomaTexasWashington
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
Lot # A5192-18338, Expiry: 12/2016
Where was it sold?
U.S. Including: CA, CT, MA, MD, NY, NJ, OK, TX, and WA
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 Taro Pharmaceuticals U
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Hydrocortisone 1% & Acetic Acid 2% Otic Solution recalled | Taro Pharmaceuticals U | Potency & Assay | NY |
| Drug | CLASS III | Clotrimazole and Betamethasone Dipropionate Cream recalledClotrimazole And Betamethasone Dipropionate | Taro Pharmaceuticals U | Potency & Assay | NY |
| Drug | CLASS I | Clobetasol Propionate Ointment USP, 0.05% tubes recalledClobetasol Propionate | Taro Pharmaceuticals U | Sterility | Nationwide |
| Drug | CLASS II | Nortriptyline HCl Capsules, USP equivalent to 10mg base recalledNortriptyline Hydrochloride | Taro Pharmaceuticals U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | H-e-b - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal recalledHEB | Taro Pharmaceuticals U | Potency & Assay | Nationwide |