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Drug company (FDA labeler)

TaSun Pharmaceutical Industries, Inc.

NDC labeler code: 51672

What is a labeler?

The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.

Official FDA data only

Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.

Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.

At a glance

1Prescription medicines
3Products (NDC)
1FDA applications
30Recalls

Prescription medicines

FDA applications for these products

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
ApprovedApplicationMedicineSponsor
March 13, 2003ANDA076174 Etodolac
ETODOLAC		Taro

The sponsor is the company that holds the FDA application; it can differ from the labeler.

Recall timeline

2026

  1. September 25, 2026 · Class III · Ongoing · D-0033-2027 · Tretinoin

    Failed Impurities/Degradation Specifications

    Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-9.

  2. September 25, 2026 · Class III · Ongoing · D-0035-2027 · Tretinoin

    Failed Impurities/Degradation Specifications

    Tretinoin Cream UPS, 0.05%, 20g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-0.

  3. August 31, 2026 · Class II · Ongoing · D-0848-2026 · Lidocaine

    Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).

    Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, L6T1C, Canada, Dist By: Taro Pharmaceuticals U.S.A. Inc. Hawthorne NY 70532 NDC: 51672-3008-5

  4. August 3, 2026 · Class II · Ongoing · D-0770-2026 · Carbamazepine

    CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing

    Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51

  5. June 17, 2026 · Class II · Ongoing · D-0628-2026 · Perampanel

    Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.

    Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 51672-4206-6

  6. March 25, 2026 · Class II · Ongoing · D-0475-2026 · Fluocinonide

    Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

    Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-1

  7. March 25, 2026 · Class II · Ongoing · D-0476-2026 · Fluocinonide

    Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

    Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-2.

  8. March 25, 2026 · Class II · Ongoing · D-0477-2026 · Fluocinonide

    Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

    Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-3.

  9. January 27, 2026 · Class II · Ongoing · D-0342-2026 · Diclofenac

    Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.

    Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1363-7

2025

  1. December 30, 2025 · Class III · Ongoing · D-0256-2026 · Fluocinolone acetonide

    Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.

    Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4

  2. November 26, 2025 · Class III · Ongoing · D-0257-2026 · Clindamycin

    Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.

    Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 1

2023

  1. November 6, 2023 · Class III · Terminated · D-0089-2024 · Hydrocortisone and acetic acid

    Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.

    Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532.

2022

  1. February 25, 2022 · Class III · Terminated · D-0727-2022 · Clotrimazole and betamethasone dipropionate

    Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample

    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 Pharmaceuticals U.S.A., Inc. Hawt

2021

  1. December 15, 2021 · Class I · Terminated · D-0375-2022 · Clobetasol propionate

    Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria

    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. NDC 51672-1259-3

  2. January 8, 2021 · Class II · Terminated · D-0246-2021 · Nortriptyline hydrochloride

    CGMP deviations.

    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 51672-4001-1

2020

  1. February 7, 2020 · Class I · Terminated · D-0863-2020 · Phenytoin

    Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.

    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. Hawthorne, NY 10532, NDC 516

2019

  1. December 20, 2019 · Class I · Terminated · D-0833-2020 · Lamotrigine

    Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.

    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, NDC 51672-4131-1.

  2. September 27, 2019 · Class II · Terminated · D-0298-2020 · Ibuprofen

    Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

    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., Inc., Hawthorne, NY 1

  3. September 27, 2019 · Class II · Terminated · D-0299-2020 · Ibuprofen

    Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

    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., Hawthorne, NY 105

2017

  1. December 21, 2017 · Class III · Terminated · D-0249-2018 · Clobetasol propionate

    Failed Content Uniformity Specifications

    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 UPC 351672125837 NDC 516

  2. September 20, 2017 · Class III · Terminated · D-0146-2018 · Fluocinonide

    Cross contamination with other products: traces of Dapsone were found in the finished product.

    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

  3. March 28, 2017 · Class II · Terminated · D-0676-2017 · Nystatin and triamcinolone acetonide

    Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability

    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 grams (NDC 51672-1263-

  4. March 17, 2017 · Class III · Terminated · D-0790-2017 · Fluocinonide

    Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.

    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, NY 10532, NDC 51672-1

2016

  1. September 13, 2016 · Class II · Terminated · D-0116-2017 · Desoximetasone

    Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).

    Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1270-7

  2. September 13, 2016 · Class II · Terminated · D-0117-2017 · Desoximetasone

    Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).

    Desoximetasone Cream USP, 0.05% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1271-7

2015

  1. August 5, 2015 · Class III · Terminated · D-1370-2015 · Desoximetasone

    Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.

    Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles, Rx Only. Mfd by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada, L6T 1C1, Dist by: TaroPharma, Hawthorne, NY 10532. NDC: 51672-5281-7.

2014

  1. October 21, 2014 · Class III · Terminated · D-0049-2015 · Carbamazepine

    Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing site for the Carbamazepine API final intermediate was pending approval.

    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. Hawthorne, NY 10532, NDC

  2. August 25, 2014 · Class III · Terminated · D-1584-2014 · Warfarin sodium

    Failed Content Uniformity Specifications.

    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., Inc., Hawthorne, NY 105

2013

  1. October 16, 2013 · Class III · Terminated · D-347-2014 · Ciclopirox

    Subpotent. drug

    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.

2012

  1. November 21, 2012 · Class II · Terminated · D-086-2013 · Fluorouracil

    Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.

    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 51672-4118-6.

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

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