CLASS III Drug recall · Reported 18 Dec 2013 · FDA Enforcement Report
Ciclopirox Shampoo recalled by Taro Pharmaceuticals U.S.A
Taro Pharmaceuticals U is recalling Ciclopirox Shampoo 1%, distributed nationwide in the US. The recall was initiated on 16 Oct 2013 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-347-2014
- FDA event ID
- 66519
- Recalling firm
- Taro Pharmaceuticals U, Hawthorne, NY
- Brand
- Ciclopirox
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 16 Oct 2013
- FDA classified
- 12 Dec 2013
- Reported
- 18 Dec 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Drug class
- Sunscreen & Personal Care
Timeline
| 16 Oct 2013 | Recall initiated by company | |
| 12 Dec 2013 | Classified by FDA | +57 days |
| 18 Dec 2013 | 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
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
Ciclopirox Shampoo 1%, Net Wt. 120 mL. bottles, Rx only. Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1. Dist. by: TARO Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-1351-8.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Subpotent. drug
Which lots are affected?
Lot #: H3135, Exp. January 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 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 |
Other Ciclopirox recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes recalled | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Ciclopirox shampoo recalled by Perrigo New YorkCiclopirox | Perrigo New York | Potency & Assay | Nationwide |