Taro Pharmaceuticals U.S.A., Inc.

Complete recall history across all FDA and CPSC categories — 36 total recalls

Taro Pharmaceuticals U.S.A., Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (36)

FDA drug safety enforcement actions by Taro Pharmaceuticals U.S.A., Inc.

Date Product Reason Class
Aug 7, 2024 Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg ... Failed Impurities/Degradation Specifications: Out-of-specification results ob... Class III
Feb 25, 2022 Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, R... Failed Content Uniformity Specifications: Out-of-specification result for the... Class III
Dec 15, 2021 Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro ... Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bac... Class I
Jan 8, 2021 Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmac... CGMP deviations. Class II
Nov 17, 2020 H-E-B - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal NET WT. 0.... Failed Impurities/Degradation Specifications: An unknown degradation impurity... Class II
Nov 17, 2020 Equate Athlete's Foot, Clotrimazole USP 1%, Antifungal Cream, Packaged as a) ... Failed Impurities/Degradation Specifications: An unknown degradation impurity... Class II
Nov 17, 2020 Kaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream, NET WT 1 oz (2... Failed Impurities/Degradation Specifications: An unknown degradation impurity... Class II
Nov 17, 2020 Best Choice, Clotrimazole Cream, USP 1%, Antifungal, NET WT 0.5 OZ (14.2g), D... Failed Impurities/Degradation Specifications: An unknown degradation impurity... Class II
Nov 17, 2020 Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT 1 ... Failed Impurities/Degradation Specifications: An unknown degradation impurity... Class II
Nov 17, 2020 CVS Health Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET ... Failed Impurities/Degradation Specifications: An unknown degradation impurity... Class II
Nov 17, 2020 Kroger Jock Itch Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT ... Failed Impurities/Degradation Specifications: An unknown degradation impurity... Class II
Nov 17, 2020 RiteAid Pharmacy RIngworm Cream, Clotrimazole Cream USP, 1%, Antifungal NET W... Failed Impurities/Degradation Specifications: An unknown degradation impurity... Class II
Nov 17, 2020 TopCare Health, Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal,... Failed Impurities/Degradation Specifications: An unknown degradation impurity... Class II
Nov 17, 2020 Kroger Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 0... Failed Impurities/Degradation Specifications: An unknown degradation impurity... Class II
Jul 20, 2020 Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) ... Failed Content Uniformity: bulk lot used to make these two lots was found to ... Class III
Feb 7, 2020 Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only... Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL ma... Class I
Dec 20, 2019 Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro P... Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with ena... Class I
Sep 27, 2019 Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-... Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small p... Class II
Sep 27, 2019 Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-... Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small p... Class II
Sep 27, 2019 Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Man... Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small p... Class II
Sep 27, 2019 Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-... Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small p... Class II
Sep 27, 2019 Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manu... Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small p... Class II
Oct 19, 2018 Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, ... Failed Impurities/Degradation Specifications: unknown impurity higher than th... Class II
Oct 19, 2018 children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, ... Failed Impurities/Degradation Specifications: unknown impurity higher than th... Class II
Oct 19, 2018 children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHIS... Failed Impurities/Degradation Specifications: unknown impurity higher than th... Class II
Dec 21, 2017 Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Phar... Failed Content Uniformity Specifications Class III
Sep 20, 2017 Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceutical... Cross contamination with other products: traces of Dapsone were found in the ... Class III
Mar 28, 2017 Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units a... Failed Content Uniformity Specifications; out-of-specification (OOS) results ... Class II
Mar 17, 2017 Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx on... Cross contamination with other products: Certain lots of Fluocinonide Cream w... Class III
May 26, 2016 Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Ka... Subpotent Drug: Out of Specification assay values on stability for the active... Class III
Mar 31, 2016 ¿Topicort (desoximetasone) Cream USP, 0.05%, Packaged in 5 g Tubes, Professio... Subpotent Drug Class III
Dec 30, 2014 Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistami... Presence of Foreign Substance: Presence of blue plastic floating in loratadin... Class II
Oct 21, 2014 Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufact... Marketed without an Approved NDA/ANDA: One lot was on hold-pending release st... Class III
Aug 25, 2014 Warfarin Sodium Tablets, USP Crystalline, 2 mg, 100 and 1000 Tablet Bottles, ... Failed Content Uniformity Specifications. Class III
Oct 16, 2013 Ciclopirox Shampoo 1%, Net Wt. 120 mL. bottles, Rx only. Mfd. by: Taro Pharm... Subpotent. drug Class III
Nov 21, 2012 Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmac... Product Lacks Stability: Out-of-specification (OOS) results were observed for... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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