Food, drugs, devices › Taro Pharmaceuticals U.S.A., Inc.

Drug recall: Ciclopirox Shampoo 1%, Net Wt. 120 mL. bottles, Rx only. Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6

FDA enforcement event 66519 · Class III · initiated 16 Oct 2013 · status Terminated · terminated 18 May 2018

DrugVoluntary: Firm initiated1 product recordHawthorne, NY

Taro Pharmaceuticals U.S.A., Inc. (Hawthorne, NY) initiated this drug recall on 16 Oct 2013; FDA lists 1 product record under event 66519, classified Class III.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 26% of the 370 drug enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 18 May 2018. Initiation: voluntary: firm initiated. Taro Pharmaceuticals U.S.A., Inc. has 21 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY.

Reason for recall

"Subpotent. drug"

Distribution

"Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-347-2014	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.	850 bottles	Class III	Terminated	18 Dec 2013

Context

26%of 2013 drug events are Class III370 events that year

1product record in this eventfirm median: 1

21events on this register for the firm

Other enforcement events for Taro Pharmaceuticals U.S.A., Inc.

Initiated	Product (first record)	Type	Class	Records
7 Aug 2024	Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, O	Drug	Class III	1
25 Feb 2022	Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceutica	Drug	Class III	1
15 Dec 2021	Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay,	Drug	Class I	1
8 Jan 2021	Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2	Drug	Class II	1
17 Nov 2020	CVS Health Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 1 OZ (28.4 g) Distributed by: CVS Pharma	Drug	Class II	10
20 Jul 2020	Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) 45 g tube, NDC: 60429-902-45, Rx Only, For E	Drug	Class III	1
7 Feb 2020	Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries Lt	Drug	Class I	1
20 Dec 2019	Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Isr	Drug	Class I	1
27 Sep 2019	Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Manufactured by: Taro Pharmaceuticals, Inc., B	Drug	Class II	5
19 Oct 2018	Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 F	Drug	Class II	3

All 21 events for Taro Pharmaceuticals U.S.A., Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Subpotent. drug"

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 18 May 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.