Taro Pharmaceuticals U.S.A., Inc.

Hawthorne, NY, United States

36

Total Recalls

3

Class I Recalls

0

Ongoing Recalls

Recalls by Taro Pharmaceuticals U.S.A., Inc.

FDA Drug Class III Completed

Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawth

August 7, 2024 Taro Pharmaceuticals U.S.A., Inc. 96 vials units
FDA Drug Class III Terminated

Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceutica

February 25, 2022 Taro Pharmaceuticals U.S.A., Inc. 768 tubes units
FDA Drug Class I Terminated

Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532

December 15, 2021 Taro Pharmaceuticals U.S.A., Inc. 96 tubes units
FDA Drug Class II Terminated

Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 NDC 51672

January 8, 2021 Taro Pharmaceuticals U.S.A., Inc. 44,256 bottles units
FDA Drug Class II Terminated

RiteAid Pharmacy RIngworm Cream, Clotrimazole Cream USP, 1%, Antifungal NET W 0.5 oz. (14.2g), Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011 Made in Canada. UPC 0 11822 53812 1

November 17, 2020 Taro Pharmaceuticals U.S.A., Inc. 34,920 0.5 oz tubes units
FDA Drug Class II Terminated

H-E-B - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal NET WT. 0.5 oz. (14.2 g), Made with Pride & Care for H-E-B San Antonio, TX 78204 Made in Canada NDC 37808-305-01

November 17, 2020 Taro Pharmaceuticals U.S.A., Inc. N/A units
FDA Drug Class II Terminated

Equate Athlete's Foot, Clotrimazole USP 1%, Antifungal Cream, Packaged as a) NET WT. 0.5 oz (14.2g), NDC 49035-812-01, b) NET WT 2 OZ (60g), NDC 49035-812-27. Distributed by: Walmart Inc., Bentonville

November 17, 2020 Taro Pharmaceuticals U.S.A., Inc. 481,896 tubes units
FDA Drug Class II Terminated

Kaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream, NET WT 1 oz (28.4 g), Manufactured by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T1C1 Distributed by Kaiser Foundation Hospita

November 17, 2020 Taro Pharmaceuticals U.S.A., Inc. 30,816 1 oz tubes units
FDA Drug Class II Terminated

Best Choice, Clotrimazole Cream, USP 1%, Antifungal, NET WT 0.5 OZ (14.2g), Distributed by: Valu Merchandisers, CO . 5000 Kansas Ave. Kansas City, KS 66106 Made in Canada. UPC 0-70038-20355-1

November 17, 2020 Taro Pharmaceuticals U.S.A., Inc. 11,088 1 oz tubes units
FDA Drug Class II Terminated

Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT 1 oz (30 g), Distributed by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10531. Made in Canada. UPC 3 51672 20022 0

November 17, 2020 Taro Pharmaceuticals U.S.A., Inc. 40,896 1 oz tube units
FDA Drug Class II Terminated

CVS Health Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 1 OZ (28.4 g) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. Made in Canada NDC 59779-305-03

November 17, 2020 Taro Pharmaceuticals U.S.A., Inc. 64,692 1 oz tubes units
FDA Drug Class II Terminated

Kroger Jock Itch Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT .5 OZ (15 g), Distributed by The Kroger CO, Cincinnati, Ohio 45202 Made in Canada, NDC 30142-510-01

November 17, 2020 Taro Pharmaceuticals U.S.A., Inc. 45,396 units units
FDA Drug Class II Terminated

Kroger Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 0.5 OZ (15g), Distributed by The Kroger Co. Cincinnati, Ohio 45202 Made in Canada. NDC 30142-305-01

November 17, 2020 Taro Pharmaceuticals U.S.A., Inc. 133,452 0.5 oz tubes units
FDA Drug Class II Terminated

TopCare Health, Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT. 0.5 oz. (14.2 g). Distributed by Topco Associates LLC, Elk Grove Village, IL 60007. NDC 36800-495-69 UPC 0 36800 4

November 17, 2020 Taro Pharmaceuticals U.S.A., Inc. N/A units
FDA Drug Class III Terminated

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 External Use Only, Not for Ophthalmic Use, Mfd by: Taro Pharmaceuticals Inc. Bra

July 20, 2020 Taro Pharmaceuticals U.S.A., Inc. 7632 tubes units
FDA Drug Class I Terminated

Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A. Inc. Hawthor

February 7, 2020 Taro Pharmaceuticals U.S.A., Inc. 29,172 8 Fl Oz bottles units
FDA Drug Class I Terminated

Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, ND

December 20, 2019 Taro Pharmaceuticals U.S.A., Inc.
FDA Drug Class II Terminated

Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz. (120 mL), Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2

September 27, 2019 Taro Pharmaceuticals U.S.A., Inc. 182,986 bottles units
FDA Drug Class II Terminated

Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc

September 27, 2019 Taro Pharmaceuticals U.S.A., Inc. 639,325 bottles units
FDA Drug Class II Terminated

Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(240 mL), Distributed by: Taro Pharmaceuticals, U.S.A., Inc., Hawthorne, NY 10532, NDC 51672

September 27, 2019 Taro Pharmaceuticals U.S.A., Inc. 5,190 bottles units
FDA Drug Class II Terminated

Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Manufactured by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., I

September 27, 2019 Taro Pharmaceuticals U.S.A., Inc. 138,886 bottles units
FDA Drug Class II Terminated

Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz.(120 mL), Distributed by: Winco Foods, LLC, Boise, ID 83704, NDC 67091-321-04

September 27, 2019 Taro Pharmaceuticals U.S.A., Inc. 5,280 bottles units
FDA Drug Class II Terminated

children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120 mL) bottle, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Par

October 19, 2018 Taro Pharmaceuticals U.S.A., Inc. 8328 bottles units
FDA Drug Class II Terminated

Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 FL OZ (120 mL) bottle, Dist. by Meijer Distribution, Inc., Grand Rapids, MI 40644

October 19, 2018 Taro Pharmaceuticals U.S.A., Inc. 12,432 bottles units
FDA Drug Class II Terminated

children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Free, 4 FL OZ (120 mL) bottle, Distributed by Rite-Aid, 30 Hunter Lane, Camp Hill, PA 17011,

October 19, 2018 Taro Pharmaceuticals U.S.A., Inc.
FDA Drug Class III Terminated

Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761 Dist. by : Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 U

December 21, 2017 Taro Pharmaceuticals U.S.A., Inc. 27,792 tubes units
FDA Drug Class III Terminated

Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton Ontario Canada L6T1C1, Dist. by: Taro Pharmaceuticals U.S.A . Inc. Hawthorne NY 10532, NDC 51672-1279-1

September 20, 2017 Taro Pharmaceuticals U.S.A., Inc. 16,944 tubes units
FDA Drug Class II Terminated

Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distributed in a) 15 grams (NDC 51672-1263-1), b) 30 grams (NDC 51672-1263-2) and c) 60 g

March 28, 2017 Taro Pharmaceuticals U.S.A., Inc. 278,304 tubes units
FDA Drug Class III Terminated

Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, N

March 17, 2017 Taro Pharmaceuticals U.S.A., Inc. 7,776 tubes units
FDA Drug Class III Terminated

Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.1% PYRITHIONE ZINC, STEP 1 PRE-TREAT Concentrated Botanical Scalp Lotion (0.1% Pyrithione

May 26, 2016 Taro Pharmaceuticals U.S.A., Inc. 17,100 kits units
FDA Drug Class III Terminated

¿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 div

March 31, 2016 Taro Pharmaceuticals U.S.A., Inc. 62,800 Tubes units
FDA Drug Class II Terminated

Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistamine, Grape Flavored Syrup, 24 Hour Non-Drowsy Allergy Relief Sugar Free, 4 FL OZ (120 mL) Bottles, Distributed by: Taro Phar

December 30, 2014 Taro Pharmaceuticals U.S.A., Inc. 36,684 Bottles units
FDA Drug Class III Terminated

Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 26110 Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawt

October 21, 2014 Taro Pharmaceuticals U.S.A., Inc. 1,966 bottles units
FDA Drug Class III Terminated

Warfarin Sodium Tablets, USP Crystalline, 2 mg, 100 and 1000 Tablet Bottles, Rx Only. Mfd. by: Taro Pharmaceutical Industries, Ltd., Haifa Bay, Israel 26110. Dist. by: Taro Pharmaceuticals U.S.A., I

August 25, 2014 Taro Pharmaceuticals U.S.A., Inc. 1396 Bottles units
FDA Drug Class III Terminated

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 5

October 16, 2013 Taro Pharmaceuticals U.S.A., Inc. 850 bottles units
FDA Drug Class II Terminated

Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmaceutical Industries, Ltd. Haifa Bay, Israel 26110, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 5167

November 21, 2012 Taro Pharmaceuticals U.S.A., Inc. 39,982 Tubes units